EECP (Enhanced External Counter Pulsation) & HBOT (Hyper Baric Oxygen Therapy) as an adjuvant therapy in ischemic cardiomyopathy.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
100 patients with refractory ischemic heart failure with reduced ejection fraction will be included in this study by invitation.
A prospective cohort study design will be employed and patient volunteers will be followed up over a period of 2 years. The volunteers after fulfilling the inclusion exclusion criteria will be subjected to baseline investigations involving 6 MWD, MLHFS, NT pro BNP, LVEF by Simpson’s biplane method and GLS using 2 dimensional echocardiography.
Patients will be subjected to daily sessions of Hyperbaric oxygen therapy ( 20 x 90 minute sessions ) followed by 40 EECP sessions ( 1 hour each ) over a period of 6 weeks. They will be assessed at the end of therapy with same investigations at baseline. Follow up will continue at frequent intervals at 6 months , 1 year and 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Ischemic HFrEF( ejection fraction less than 50%) with NYHA Class 2 or more symptoms despite optimal GDMT.
- •Post revascularization on GDMT with worsening heart failure symptoms.
- •Coronary anatomy not suitable for repeat revascularization.
排除标准
- •Recent acute coronary syndrome (within 1 month).
- •Recent PTCA ( less than 2 weeks) or CABG (within 3 months).
- •Severe peripheral arterial disease, greater than Moderate Aortic regurgitation or stenosis, HOCM, severe Mitral regurgitation, DVT , Arterial aneurysms, AFib with FVR , bleeding disorders, and uncontrolled hypertension.
- •Volume overloaded pts.
结局指标
主要结局
MACE
时间窗: 6 months | 1 year | 2 year
First hospitalization due to heart failure
时间窗: 6 months | 1 year | 2 year
次要结局
- All cause mortality.(Change from baseline in the clinical summary on the Minnesota living with heart failure score(MLFHS).)
研究者
Dr Sama Akber DNB DM
Oxymed Hospital