A Registry-Based Randomised Controlled Trial With Heart 4 Data - SELEnium and CoQ10 NuTrition for Heart Failure: H4D-SELEQT-HF
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,100
- 试验地点
- 13
- 主要终点
- Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death
研究概览
简要总结
The goal of this clinical trial is to learn whether taking selenium and coenzyme Q10 (CoQ10) can reduce HF related events and deaths related to cardiovascular disease.
Researchers will compare selenium-CoQ10 supplements with a placebo to see if the supplements improve heart health and patient outcomes.
Participants will:
Receive either selenium-CoQ10 or placebo in addition to their usual heart failure treatment
Attend standard clinical visits according to routine clinical care.
The study will include 1,100 adults with chronic heart failure. Selenium and CoQ10 are natural nutrients with no known health risks. If effective, this supplement could provide a safe new way to improve outcomes for people with heart failure.
详细描述
This randomized controlled trial will be a pragmatic registry based clinical trial (RBRCT), using existing infrastructure on quality reporting of cardiovascular disease management in the Netherlands. This registration platform (Netherlands Heart Registration (NHR) forms the basis of incorporating information of patients with HF in hospitals in the Netherlands. Using the data gathered through this registry, these data will serve as source documentation for the electronic case report form of the current RBRCT and requires only limited additional information. Through the same system, randomization, (Serious) adverse event reporting, endpoint reporting and investigational product allocation will be conducted. Investigational product (selenium/CoQ10 supplementation or placebo) will be distributed from central pharmacy to the home of the patient. Apart from telephone calls at 6 months after randomization and every 12 months thereafter, there will be no study visits and the data gathering will be conducted through routine clinical care and registrations that are already in place. SELEQT-HF is an event driven RBRCT, with an expected median follow up of 2 years.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age >18 years
- •Outpatients with chronic HF, NYHA II - ambulatory IV
- •Serum NT-proBNP concentrations >600 pg/mL (71 pmol/L) if in sinus rhythm; >1000pg/mL (118 pmol/L) if in Atrial fibrillation*
排除标准
- •History of myocardial infarction, myocarditis, percutaneous intervention, cardiac surgery or stroke <30 days
- •The presence of a mechanical assist device
- •Scheduled for mechanical assist device or heart transplant
- •Other non-cardiac conditions with limited life expectancy (<1 year)
- •Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
- •End stage kidney disease for which chronic intermittent peritoneal or haemodialysis
- •Unable to sign informed consent
- •(Unwilling to stop) use of over the counter supplements coQ10/selenium
- •Peanut and/or soy allergy
研究组 & 干预措施
Placebo
干预措施: Matching Placebo (B) (Drug)
Selenium/CoQ10
Oral dosage of twice daily Selenium/CoQ10 (2 x 100 μg selenium tablets (SelenoPrecise 100 μg, Pharma Nord, Denmark) and 2 x 100 mg Q10 capsules (Bio-Quinon 100 mg B.I.D, Pharma Nord, Denmark)
干预措施: Selenium/CoQ10 (Dietary Supplement)
结局指标
主要结局
Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death
时间窗: ongoing, up to ~30 months
Total (first and subsequent) HF hospitalizations, urgent visits for HF visits and cardiovascular deaths with selenium/coQ10 compared to placebo.
次要结局
- Total number of events of (repeated) HF hospitalization and (repeated) urgent HF visits(ongoing, up to ~30 months)
- Time to death from any cause(ongoing, up to ~30 months)
- Time to cardiovascular death(ongoing, up to ~30 months)