PhotobiomoduLation for pAtientS With Advanced hEart failuRe
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Echocardiographic response
研究概览
简要总结
The objective of the study is to examine the effectiveness of photobiomodulation therapy in patients with advanced-stage heart failure with reduced ejection fraction (HFrEF), who have been referred but ineligible for a heart transplantation. The primary endpoint is a 15% relative reduction in left ventricular end-systolic volume (LV ESV) as determined by echocardiography over a 12-month follow-up period. The secondary objective is to determine the change in NT-proBNP, a biomarker for heart failure, the change in heart failure symptoms based on the NYHA functional classification, the change in quality of life questionnaire (KCCQ), additional echocardiographic parameters, and the detection of changes in heart failure and fibrosis biomarkers. Additionally, the study aims to examine hospitalization due to heart failure and overall mortality.
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
- •Advanced-stage HFrEF patients who were ineligible for heart transplantation Patients over 18 years of age The expected lifespan exceeds 1 year Consent form
排除标准
- •Non-compliant patient Pregnant women Drug or alcohol abuse The patient is participating in another clinical trial
结局指标
主要结局
Echocardiographic response
时间窗: 12 months
At least 15% reduction of end-systolic volume
次要结局
- Other echocardiographic response(12 months)
- Biomarker changes(12 months)
- Qulaity of Life(12 months)
- Symptomes(12 months)
- All-cause mortality or HF hospitalisation(12 months)
研究者
Annamaria Kosztin MD, PhD
Principal Investigator
Semmelweis University Heart and Vascular Center