Phase II Study of Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Peak Aerobic Exercise Capacity
研究概览
简要总结
Non-ischemic cardiomyopathy and heart failure are highly influenced by the presence of systemic inflammation.
Doxycycline is a FDA-approved drug to treat bacterial infections which also shows powerful anti-inflammatory effects.
In this study we plan to determine the effects of Doxycycline in patients with stable heart failure and non-ischemic cardiomyopathy on peak of aerobic exercise capacity (peak V02) and ventilator efficiency measured with a cardiopulmonary test.
详细描述
In this study of Safety and Efficacy of Doxycycline in Patients with Non-Ischemic Cardiomyopathy Population, we will enroll 24 patients with a clinical diagnosis of heart failure and non-ischemic cardiomyopathy (recent imaging study documenting LV ejection fraction <50%, and no history of coronary or ischemic heart disease) in a single-center, randomized, double-blinded, placebo-controlled clinical trial with allocation 1:1:1 to Doxycycline 100 mg twice daily or Doxycycline 20 mg twice daily or Placebo for 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-ischemic cardiomyopathy (LVEF<40%)
- •Heart failure NYHA II-III
排除标准
- •Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme [ACE] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
- •Hospitalization for worsening HF or acute decompensated HF within the previous 12 months
- •History of coronary or ischemic heart disease
- •Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD) or coronary revascularization or cardiac surgery
- •Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
- •Active infection including chronic infection
- •Active cancer (or prior diagnosis of cancer within the past 10 years)
- •Recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
- •Pregnancy
- •Inability to give informed consent
- •Other conditions limiting completion of cardiopulmonary exercise test or completion of the study
研究组 & 干预措施
Placebo
Placebo
干预措施: placebo (Drug)
Doxycycline 100 mg
Doxycycline 100 mg twice daily for 14 days
干预措施: Doxycycline (Drug)
Doxycycline 20 mg
Doxycycline 20 mg twice daily for 14 days
干预措施: Doxycycline (Drug)
结局指标
主要结局
Peak Aerobic Exercise Capacity
时间窗: 14 days
Interval change in peak VO2 measured at cardiopulmonary test
次要结局
未报告次要终点