A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure (DANUTRIO-HF: Q10, DANUTRIO-HF: Selenium)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4,044
- 试验地点
- 1
- 主要终点
- Time to the first occurrence of hospitalization for heart failure or cardiovascular death
研究概览
简要总结
Heart failure is a common and serious condition. Despite rapid advancements in heart failure treatment, the prognosis remains severe. Smaller studies have shown that two simple, safe, and relatively inexpensive nutritional supplements-coenzyme Q10 and selenium-may reduce the risk of complications associated with heart failure. The DANUTRIO-HF trial will investigate whether these supplements can make a difference for individuals with heart failure. The study will assign approximately 4,044 patients from across Denmark to either coenzyme Q10 (100 mg twice daily) or a corresponding placebo, as well as selenium (100 μg twice daily) or its corresponding placebo, and follow how many of them end up being hospitalized for heart failure or dying from heart problems over an estimated two to three-year period.
详细描述
This investigator-initiated, pragmatic, registry-based, double-blinded, placebo-controlled, 2x2 factorial, individually randomized trial aims to evaluate the efficacy of daily intake of the nutritional supplements coenzyme Q10 versus placebo, and selenium versus placebo, in preventing heart failure hospitalizations and cardiovascular death in heart failure patients. The trial plans to randomize approximately 4,044 participants in an event-driven design. Participants will be identified through the Danish Administrative Health Registries, which will also serve as the primary source for data collection. Contact with potential participants will be made via the mandatory Danish electronic letter system. No scheduled in-person visits are required in the main study, and all study interventions will be mailed to participants.
A substudy involving up to 600 participants will assess the effects of coenzyme Q10 and selenium on functional capacity, treatment compliance, biochemical biomarkers, and cardiac function and structure. This group will attend two in-person visits for additional evaluations, including echocardiography, blood sampling, and a 6-minute walk test at baseline and at the 1-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Individuals aged ≥ 18 years.
- •Registered with a heart failure diagnosis (ICD-10: I50) as a primary discharge diagnosis in The Danish National Patient Registry and at least one claimed prescription of a renin-angiotensin-system inhibitor and a β-blocker within 120 days after HF diagnosis.
- •Informed consent form has been signed and dated.
排除标准
- •Use of vitamin K-antagonist
- •Registered with a cancer diagnosis (C00-C97 not C44) within the last 5 years excluding cutaneous squamous cell or basal cell carcinoma in The Danish National Patient Registry.
研究组 & 干预措施
Coenzyme Q10 intervention, active
100 mg capsules given twice daily, per oral use
干预措施: Coenzyme Q10 100 Milligrams Oral Capsule (Dietary Supplement)
Coenzyme Q10 intervention, placebo
Placebo matching coenzyme Q10
干预措施: Coenzyme Q10 100 Milligrams Oral Capsule (Dietary Supplement)
Selenium intervention, active
100 μg tables given twice daily, per oral use
干预措施: Selenium 100 Micrograms Oral Tablets (Dietary Supplement)
Selenium intervention, placebo
100 μg tables given twice daily, per oral use
干预措施: Selenium 100 Micrograms Oral Tablets (Dietary Supplement)
结局指标
主要结局
Time to the first occurrence of hospitalization for heart failure or cardiovascular death
时间窗: From date of randomization until end of study (Up to approximately 33 months)
次要结局
- Time to first occurrence of hospitalization for heart failure(From date of randomization until end of study (Up to approximately 33 months))
- Time to cardiovascular death(From date of randomization until end of study (Up to approximately 33 months))
研究者
Tor Biering-Sørensen
Professor, MD, MSc, MPH, PhD
Herlev and Gentofte Hospital