A Phase IV Randomized, Double-blind, Active-controlled, Single-center Study of the Safety and Effects on Cardiac Structure and Function of Hydralazine and Isosorbide Dinitrate in Patients With Hemodialysis Dependent ESRD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Rate of Hypotension, Serious Adverse Events, GI Events and Cardiovascular Death
研究概览
简要总结
This study is a pilot study designed to compare the safety and cardiovascular effects of 26 weeks of combination hydralazine/isorsorbide dinitrate therapy with placebo therapy in patients receiving chronic hemodialysis.
The investigators hypothesize that treatment of chronic hemodialysis (ESRD) patients with a combination of hydralazine/isosorbide dinitrate compared with placebo is safe and that it will improve heart function as well blood flow/blood vessel supply.
详细描述
Sixteen patients receiving maintenance hemodialysis will be randomized to 26 weeks of therapy with combination hydralazine/isosorbide dinitrate or placebo. Study medications will be titrated to goal dose during the first 4 weeks and maintained at goal dose (as tolerated) between weeks 4-26. A final study visit to assess symptoms after drug discontinuation will occur 4 weeks after drug discontinuation.
Study duration-Maximum of 32 weeks with 26 weeks of active therapy.
Efficacy Measures -Tissue Doppler echocardiography and myocardial perfusion scanning using radioactive NH3 PET will be assessed at weeks 0 and 26.
Safety Measures-Adverse events rates including inter- and intra-dialytic hypotension, ,cardiovascular death and gastrointestinal symptoms will be assessed throughout the duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hydralazine/Isorsorbide Dinitrate
Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.
Allowable Dosage Forms:
ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35mg-3x/day ISD/HY 40 mg/75 mg-3x/day
干预措施: Hydralazine/Isorsorbide Dinitrate (Drug)
Placebo
Placebo will be administered Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of Hypotension, Serious Adverse Events, GI Events and Cardiovascular Death
时间窗: 6 months
Rate of primary Safety Outcomes(hypotension, serious adverse events, GI events and CV death)
Change in E' on TDI Echo From 0-6 Months
时间窗: 0 to 6 months
Co-primary efficacy measure measured on Tissue Doppler Echocardiography
Reduction in Drug Dose or Discontinuation of Study Drug
时间窗: 0 to 6 months
Primary Tolerability measure
Efficacy-Change in Coronary Flow Reserve (CFR) From 0-6 Months
时间窗: 0 to 6 months
Primary Efficacy Measure-CFR measured on rest and stress Positron Emission Tomography
Number of Patients Completing Study From 0 to 6 Months
时间窗: 0 to 6 months
Primary Feasibility Measure
次要结局
- Change in Circulating Fibrosis Markers and Angiogenesis Markers(0 to 6 months)
- Change in LVMI(0 to 6 months)
研究者
David Charytan M.D.
Assistant Professor of Medicine
Brigham and Women's Hospital