Clinical trials in degenerative diseases最新文献

{"title":"Changes in insulin resistance and inflammatory factors in cataract patients with glaucoma after phacoemulsification and trabeculectomy: a self-controlled trial","authors":"Jianfeng Zhao, Yu Geng, Qian-bo Chen, Jinghong Yang, Yan Li","doi":"10.4103/2542-3975.267998","DOIUrl":"https://doi.org/10.4103/2542-3975.267998","url":null,"abstract":"Background and objective: Cataract with glaucoma can adversely affect visual acuity and corneal endothelial cells. Studies have shown that after phacoemulsification combined with trabeculectomy in patients with cataract and glaucoma, blood lipid ratio and insulin sensitivity are associated with intraocular pressure, visual acuity and corneal endothelial cells, which may be used for the evaluation of efficacy. Interleukins are the main mediators of the inflammatory response and are involved in the pathogenesis of cataract. In this trial, we will examine the postoperative changes in interleukin-10, interleukin-2 and interleukin-1β levels in patients with cataract with glaucoma, and analyze the correlation between insulin sensitivity and corneal endothelial cell density to assess whether inflammatory factors can be used to evaluate efficacy. Participants and methods: This prospective, single-center, open-label, self-controlled clinical trial will include 160 patients with cataract combined with glaucoma, 35–65 years of age, from the Department of Ophthalmology, First Affiliated Hospital of Kunming Medical University, China. All patients will receive phacoemulsification and trabeculectomy, and will be followed up at 5 days, and at 1 and 3 months. Patient recruitment will begin on December 30, 2019 and end on December 30, 2020. Analysis of the results will be performed from May 1, 2021 to May 30, 2021. This study is scheduled to end on June 30, 2021. This study was approved by the Medical Ethics Committee, First Affiliated Hospital of Kunming Medical University, China, on December 15, 2013 (approval No. 20131215085), and will be performed in accordance with the principles of the Declaration of Helsinki, adopted by the World Medical Association. Study protocol version is 1.0. Written informed consent to participate will be obtained from each participant. Results: The primary outcome measure will be serum interleukin-2 level, as an index of the inflammatory response, 3 months after surgery. Secondary outcome measures will include serum interleukin-2 level before and 5 days and 1 month after surgery, serum levels of interleukin-1β, interleukin-10, C-reactive protein and tumor necrosis factor-α, best corrected visual acuity, endothelial cell density, mean cell area, coefficient of variation, insulin sensitivity index and intraocular pressure before and 5 days and 1 and 3 months after surgery, and incidence of adverse reactions at 5 days and 1 and 3 months after surgery. From January 2014 to June 2017, our team undertook and completed a small-sample study of 80 cataract patients (95 eyes) with glaucoma. The best corrected visual acuity was significantly improved, endothelial cell density and intraocular pressure were significantly reduced, interleukin-1β, interleukin-2, interleukin-10, C-reactive protein and tumor necrosis factor-α levels were significantly decreased (P < 0.05), and mean cell area, coefficient of variation and insulin sensitivity index wer","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"28 1","pages":"81 - 87"},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82051231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A study protocol on effectiveness of theory-based intervention on self-care and glycated hemoglobin among type 2 diabetes patients in National Center for Diabetes in Yemen","authors":"A. Al-Washali, A. Hejar, K. Hayati, I. Suriani, Yahya A Elezzy","doi":"10.4103/2542-3975.267995","DOIUrl":"https://doi.org/10.4103/2542-3975.267995","url":null,"abstract":"Background and objectives: Diabetes is a complex, chronic illness that needs unceasing medical care with multifactorial risk-reduction strategies. Adequate glycemic control is recommended to reduce diabetes complication. Adequate self-care is important to improve glycemic control. Despite the importance of glycemic control, the majority of diabetic patients in Yemen have poor glycemic control. Poor glycemic control is a sign of poor self-care behaviors. Inadequate self-care increases patient’s morbidity and mortality, costs of medication and laboratory tests and cost in time and effort of care providers. The purpose of this study was to develop, implement, and evaluate the effect of Information-Motivation-Behavioral Skills (IMB) model-based Diabetes Self-Management on diabetes self-care behaviors (diet, physical activity, and foot care) and glycated hemoglobin among patients with type 2 diabetes in the National Center for Diabetes in Yemen. Subjects and methods: This is a parallel-randomized controlled trial, which will be conducted at the National Center of Diabetes in Yemen. Eligible participants who give consent will be randomized to an intervention group and a control group (usual care) after baseline assessment. The intervention group will receive the intervention, which is a 3-hour session, based on the information motivation behavioral skills model to improve the self-care behaviors (diet, physical activity, and foot care) and glycated hemoglobin. A post-intervention assessment will be done at 6 months after the intervention. Patient recruitment began in February, 2018. Analysis of primary outcome measure will be completed in July 2019, and the study will be finished in September 2019. Study protocol: 1.0. The protocol was approved by the Ethics Committee for Research Involving Human Subjects from Universiti Putra Malaysia on February 7, 2017 (reference No. FPSK (FR16) 015) and Al Thawra Hospital Ethics Committee (reference No. 2/2018). Outcome measures: The primary outcomes of this study are the changes in diabetes self-care behaviors (diet, physical activity, foot care) and glycated hemoglobin. The secondary outcomes are the changes in information motivation and behavioral skills of diet, physical activity, and foot care. Discussion: This theory-based randomized controlled trial aims to improve the glycemic control of patients with type 2 diabetes through improving the adherence to diabetes self-care behaviors. Trial registration: This trial was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) (registration number: ACTRN12617001037392) on July 17, 2017. http://www.anzctr.org.au/ACTRN12617001037392.aspx","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"7 1","pages":"65 - 69"},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81758244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of electroanalgesia on knee osteoarthritis: study protocol for a randomized, triple-blind, placebo-controlled trial","authors":"C. Almeida, K. Azevedo, T. Cacho, Júlia Leal, Geovanna Montanini, Danielly NeryT Silva, Patrícia Garcia, J. Durigan","doi":"10.4103/2542-3975.267996","DOIUrl":"https://doi.org/10.4103/2542-3975.267996","url":null,"abstract":"Background and objectives: Osteoarthritis of the knee is considered the major cause of pain and dysfunction of the motor apparatus and mainly affects female individuals over 60 years. Electrotherapy presents a reasonable level of evidence for pain control and inconsistent results. Thus, this study aims to verify the efficacy of electroanalgesia, using different currents, for knee osteoarthritis. Subjects and methods: This is a randomized, triple-blind, placebo-controlled clinical trial. Individuals will be randomly divided into four groups, and subjected to four different types of currents: transcutaneous electric nerve stimulation in Group 1, bipolar interferential current in Group 2, Aussie in Group 3, and placebo in Group 4, presenting different modulations and 20 minutes of intervention each. Patients have been recruited since August 2017. The primary outcome measures will be analyzed in June 2020 and the study will finish in August 2020. Protocol version: 1.0. This study was approved by the Ethics Committee of University of Brasilia on July 18, 2017 (CAEE: 62256516.2.0000.0030). Outcome measures: Primary and secondary outcomes will be analyzed at baseline, 1, 3 and 6 months after the start of the study. The primary outcome is pain assessed by numerical verbal scale, pain-pressure threshold, and brief pain inventory. The secondary outcomes are function and quality of life (including Western Ontario and McMaster Universities Osteoarthritis Index, The Medical Outcomes Study 36-item Short-Form Health Survey, Timed Get-Up-and-Go test, 30-second Sit-to-Stand test, Stair-ascend test, 6-minute walk test, 40-meter fast-walk test). Discussion: We hope to provide evidence for finding suitable electroanalgesia on knee osteoarthritis. Trial registration: Registered in the Brazilian Clinical Trials Registry (ReBEC) (RBR-875zsw) on November 24, 2017.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"9 1","pages":"70 - 75"},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90970917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Relationship between low vitamin D status and extra-skeletal diseases: a systematic review on effects of prophylaxis with vitamin D","authors":"L. Magnani","doi":"10.4103/2542-3975.260959","DOIUrl":"https://doi.org/10.4103/2542-3975.260959","url":null,"abstract":"Background and objective: A recent body of observational evidence has suggested that the low vitamin D status is related to various diseases, both skeletal and extra-skeletal muscle, including cardiovascular disease, chronic obstructive pulmonary disease and cystic fibrosis, inflammatory bowel disease, cancer, diabetes, immune system diseases (allergies), generating a growing use of supplementation, and at high doses. We conducted this systematic review with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)statement, to summarize the scientific literature concerning the role of low-level vitamin D in the extra-skeletal outcomes and the effects of supplementation. Materials and methods: Articles from PubMed, MEDLINE,and Cochrane Library were searched. Finally, 18 systematic reviews/meta-analyses, 11 documents of scientific societies/guidelines/editorials/books, and 19 interventions and observational studies (of which 5 randomized controlled trials) were included. Results: It has been found that, despite there is a large amount of observational cohort studies and anecdotal evidence of the benefits of vitamin D supplementation both on skeletal and extra-skeletal outcomes, more research is needed to verify the causality (and not only correlation) of low vitamin D status on extra-skeletal outcomes, considering that solid evidence from randomized controlled trials or other intervention studies are few, that the results of different randomized controlled trials cancel each other coming to opposite conclusions and that pervasive methodological defects make the evidence unreliable. Conclusion: Vitamin D supplementation for extra-skeletal outcomes does not seem justified, if not in clinically documented deficiencies or in specially designed clinical trials.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"33 1","pages":"56 - 63"},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74546003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Role of trace mineral in periodontal health: a review","authors":"Adiya Apon, P. Kamble","doi":"10.4103/2542-3975.260960","DOIUrl":"https://doi.org/10.4103/2542-3975.260960","url":null,"abstract":"Periodontal diseases are microbial induced chronic inflammatory conditions characterized by infiltration of leukocytes, loss of connective tissue, alveolar bone resorption, and formation of periodontal pockets. In response to periodontal pathogens, leukocytes elaborate destructive oxidants, proteinases and other factors. Periodontal disease is a chronic inflammatory disease, which leads to alteration of the micronutrient levels such as zinc, selenium, iron and copper. The imbalance of the micronutrient levels leads to increased susceptibility to oxidative damage of tissues. These micronutrients play a role in both health and disease. The vitality of the periodontal tissues in both health and disease depends on the adequate source of essential nutrients being available to the host. Micronutrients are imperative for optimum host response. Populations worldwide are prone to their insufficiency due to lifestyle changes or poor nutritional intake. Balanced levels of these trace minerals such as iron, zinc, selenium and copper are essential to prevent progression of chronic conditions like periodontitis. Their excess as well as deficiency is detrimental to periodontal health. Selenium, zinc and copper are integral components of antioxidant enzymes and prevent reactive oxygen species induced destruction of tissues. Their deficiency can worsen periodontitis associated with systemic conditions like diabetes mellitus. This review focused on the role of micronutrients, namely, iron, zinc, selenium and copper in periodontal health and their association with chronic periodontitis.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"225 1","pages":"30 - 36"},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76215456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical progress of cell therapy in treating age-related macular degeneration","authors":"L. Diao, Pan-Feng Fang","doi":"10.4103/2542-3975.260958","DOIUrl":"https://doi.org/10.4103/2542-3975.260958","url":null,"abstract":"Age-related macular degeneration is a retinal degenerative lesion caused by cell atrophy and dysfunction of retinal pigment epithelium. The degeneration of retinal pigment epithelium cells further leads to the apoptosis of photoreceptor cells, causes vision deterioration and eventually even blindness. Age-related macular degeneration is one of the top three retinal diseases causing blindness in the world. In recent years, exogenous retinal pigment epithelium cell therapy has emerged as a breakthrough treatment for age-related macular degeneration disease. In this review, we will briefly introduce the policies and regulations of cell therapy and discuss the clinical progress in the treatment of age-related macular degeneration using retinal pigment epithelium cells.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"6 1","pages":"37 - 42"},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87041217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hemodynamic responses of patients with stable coronary artery disease to a comedy film: study protocol for a randomized controlled trial","authors":"R. Nery, R. Buhler, D. Macedo, J. Delfino, F. Ferrari, A. Silveira, Marco Aurélio Lumertz Saffi, R. Stein","doi":"10.4103/2542-3975.260956","DOIUrl":"https://doi.org/10.4103/2542-3975.260956","url":null,"abstract":"Background and objective: Alternative and complementary interventions have been developed in an attempt to improve treatment and increase the survival of patients with coronary artery disease (CAD); one such intervention is laughter therapy. However, there is very little information on the effect of this therapeutic modality in patients with CAD. The present randomized controlled trial will compare the effect of 24 sessions of a comedy film and neutral documentary in patients with CAD. Subjects and methods: This is a randomized, parallel-design, examiner-blinded and controlled clinical trial. Patients with stable CAD of both sexes, aged ≥ 18 years, receiving regular follow-up at a public university hospital in Southern Brazil will be included in the trial. Subjects will be randomly allocated to an intervention group (will watch a 30-minute comedy film) or a control group (will watch a 30-minute neutral documentary). Patient recruitment will end in December 2019. Analysis of the primary outcome measure will be completed in December 2019. The current protocol version is 1.0. The study protocol was approved by the Institutional Review Board of Hospital de Clínicas de Porto Alegre (protocol No. 13-0124) on July 9, 2013. Outcome measures: The primary outcomes are the difference from baseline to the 2-month time point (corresponding to 24 sessions) in endothelial function, as assessed by brachial artery flow-mediated dilation measurement and peak oxygen consumption (peak VO2) on cardiopulmonary exercise testing. Secondary outcome measures include concentrations of inflammatory markers in blood, biochemical parameters, and quality of life. Discussion: This study will provide new evidence on the effect of an easy-to-use, inexpensive, readily deployable non pharmacological therapeutic intervention for patients with stable CAD. Trial registration: ClinicalTrials.gov identifier: NCT02824120. Date of registration: July 6, 2016.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"22 1","pages":"43 - 48"},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85907850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tanreqing injection with ambroxol hydrochloride for heart failure and pulmonary infection in senile degenerative heart disease: a randomized controlled trial","authors":"Guang Zhao","doi":"10.4103/2542-3975.260957","DOIUrl":"https://doi.org/10.4103/2542-3975.260957","url":null,"abstract":"Background and objective: Degenerative changes in the heart with age and decreased immune function mean that older adult patients with heart failure are vulnerable to infection by pathogenic bacteria. Tanreqing injection, a traditional Chinese compound medicine, has the functions of clearing heat, eliminating phlegm, and detoxifying, and can be used to treat pulmonary infection. We hypothesized that Tanreqing injection combined with ambroxol hydrochloride, a mucolytic drug, may effectively alleviate pulmonary infection and improve cardiac function in older adult patients with heart failure and pulmonary infection caused by degenerative heart disease. Participants and methods: This prospective, single-center, randomized, controlled clinical trial will include 320 patients with heart failure combined with pulmonary infection induced by senile degenerative heart disease from Sanya People’s Hospital, Sanya, China. All patients will receive conventional anti-heart failure treatment, and will be equally and randomly divided into a control group and a trial group. Patients in both groups will be treated with intravenous infusion of ambroxol hydrochloride, while patients in the trial group will additional receive Tanreqing injection. The treatment period will be 7 days. Patient recruitment and data collection will begin on July 1, 2019 and end on August 30, 2021. Analysis of the results will be performed from September 10–30, 2021. This study is scheduled to end on December 30, 2021. The study protocol was approved by the Medical Ethics Committee of Sanya People’s Hospital in October 2015 (approval No. S2015-065-03). Study protocol version is 1.0. This study will be performed in accordance with the principles of the Declaration of Helsinki. Written informed consent to participate will be obtained from participants or their family members. Results: The primary outcome measure is total effective rate after 7 days of treatment. Secondary outcome measures are change from baseline in left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular ejection fraction, left ventricular fractional shortening, number of pathogenic bacteria in the lung, serum procalcitonin level, and C-reactive protein level after 7 days of treatment, as well as incidence of adverse reactions after 7 days of treatment. In a pilot study among 120 patients with senile heart failure conducted from May 2016 to October 2017, patients were randomly assigned to trial and control groups (n = 60 per group). Gram-positive bacteria were found to be the main pathogens responsible for pulmonary infection in senile patients with heart failure, with a positive rate of 53.7% in both control and trial groups. After treatment, the number of pathogenic bacteria in the trial group was markedly lower than that in the control group (11 strains versus 17 strains). Furthermore, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and left ventri","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"13 1","pages":"49 - 55"},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79488347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of exergames on motor coordination and balance in convalescent drug addicts: a feasibility study","authors":"Adriele Nunes Sales, Jane Terezinha Finckler Botelho, A. Dumont, A. Kleiner, G. Melo","doi":"10.4103/2542-3975.254108","DOIUrl":"https://doi.org/10.4103/2542-3975.254108","url":null,"abstract":"Background and objectives: Drugs are public health problem in terms of mental and physical impairments. As respect to the physical commitments, addicted people present severe motor coordination and balance disturbances. The aim of this study was to evaluate the effect of exergames on the rehabilitation of motor coordination and balance in recovering drug addicts. Participants and methods: This is a prospective non-randomized, self-controlled study. Nine male addicts aged 25.78 ± 6.76 years were recruited from the Rescuing Lives Center for Recovery from Alcohol and Drugs, Altamira, Brazil. The intervention consisted of sixteen 45-minute sessions involving the use of virtual reality games (Xbox 360 Kinect console). Evaluations were performed before and after the intervention. The static and dynamic balance was accessed by the Berg Balance Scale, Timed Up and Go test and 6-minute walk test. The motor coordination was assessed by the Senior Motor Scale. Gait was also analyzed using an inertial sensor (G-Walk). This study was conducted at the Rescuing Lives Center for Recovery from Alcohol and Drugs, Altamira, Brazil and received approval from the Human Research Ethics Committee of the Universidade do Estado do Para - XII Campus (certificate number: 2.129.360) on April 7, 2017. Written informed consent was obtained from each participant. Results: Significant improvements were found in the Berg Balance Scale, Senior Motor Scale and Timed Up and Go test (sitting and standing) after intervention (P 0.05). Conclusion: Virtual reality is a promising technology for improving motor coordination and balance in recovering drug addicts.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"128 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85599692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of beraprost sodium on pulmonary hypertension due to left ventricular systolic dysfunction: protocol for a randomized controlled clinical trial","authors":"Li Wang, Yuqi Chen, Liangping Zhao, Xiansong Chang, Xiang Liu, Wen-Jing Wang, Jianchang Chen, Wei-ting Xu","doi":"10.4103/2542-3975.254107","DOIUrl":"https://doi.org/10.4103/2542-3975.254107","url":null,"abstract":"Background and objectives: Beraprost sodium is mainly adapted to peripheral chronic arterial occlusive disease. However, the efficacy and safety of beraprost sodium in patients with pulmonary hypertension (PH) due to left ventricular systolic dysfunction (PH-HFrEF) remain unknown. The main objective of this study is to ascertain the efficacy and safety of beraprost sodium in the treatment of PH-HFrEF. Subjects and methods: In this prospective, multi-center, randomized, controlled clinical trial, 462 consecutively recruited patients with PH-HFrEF are randomly assigned to receive routine treatment only or routine treatment in combination with oral administration of beraprost sodium 1 μg/kg for 1 year. All patients are followed up at 3, 6, 9 and 12 months after treatment. Systolic pulmonary artery pressure and left ventricular ejection fraction are assessed by echocardiography, and exercise tolerance is assessed by a 6-minute walk test. Cardiac events are also recorded. This trial was approved by the Medical Ethics Committee of the Second Affiliated Hospital of Soochow University (approval number: JD-LK-2017-021-02). Patient recruitment began in February 2018. Analysis of primary outcome measure will be completed in September 2021, and the study will be finished in September 2021. Outcome measures: Outcome measures are assessed at baseline and at 3, 6, 9 and 12 months after treatment. The primary outcome measure is the reduction rate of systolic pulmonary artery pressure. The secondary outcome measures are the incidence of major adverse cardiac events, left ventricular ejection fraction, and 6-minute walking distance. Discussion: Results of this study will provide evidence to validate whether application of beraprost sodium based on routine treatment can further reduce pulmonary artery pressure, improve cardiac function, reduce the incidence of heart events, and finally determine whether beraprost sodium is suitable for the treatment of PH-HFrEF. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-17012961) on October 12, 2017.","PeriodicalId":92014,"journal":{"name":"Clinical trials in degenerative diseases","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81884701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}