2023-509898-23-00招募中4 期
DECISION; Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 982
- 试验地点
- 1
- 主要终点
- The primary endpoint is the composite of (repeated) HF hospitalizations, (repeated) urgent HF hospital visits and cardiovascular death.
研究概览
简要总结
To study whether low-level digoxin reduces the composite primary endpoint of (repeated) HF hospitalizations, (repeated) urgent HF hospital visits and cardiovascular mortality, compared to placebo, in chronic HF.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18year
- •Outpatients with chronic HF, NYHA II - ambulatory IV
- •Serum NT-proBNP concentrations (max 1 month old): Previous HF hospitalization ≤ 1 year before randomisation ≥400pg/mL if sinus rhythm; ≥800pg/mL if AF Previous HF hospitalization > 1 year before randomisation or in the absence of HF hospitalizations ≥ 600pg/mL if sinus rhythm; ≥1000 pg/mL. if AF BNP concentrations (max 1 month old): Previous HF hospitalization ≤ 1 year before randomisation ≥100pg/mL if sinus rhythm; ≥200pg/mL if AF Previous HF hospitalization > 1 year before randomisation or in absence of HF hospitalization ≥150pg/mL if sinus rhythm; ≥250pg/mL if AF.
- •≥14 days stable on guideline-recommended therapy (doses and number of therapies as tolerated by each patient)
排除标准
- •Heart rate ≤60bpm (if sinus rhythm); heart rate ≤70bpm (if AF)
- •Accessory atrio-ventricular pathway (e.g. Wolf-Parkinson-White syndrome)
- •(Intermittent) complete heart block or second-degree AV block type Mobitz without pace maker or ICD
- •Severe (grade III/III) aortic valve disease
- •Complex congenital heart disease
- •Proven hypersensitivity to digoxin (prior side effects)
- •Concomitant medication that interacts with digoxin (see appendix 2, prohibited medication)
- •Use of digoxin ≤6 months prior to inclusion
- •Participation in another (intervention) clinical trial (registry studies not included)
- •Women who are pregnant, breastfeeding or may be considering pregnancy during the study period
- •History of HF hospitalization ≤7days
- •History of myocardial infarction, myocarditis, percutaneous intervention, RCT, pacemaker/ICD implantation, cardiac surgery or stroke ≤30 days
- •Estimated glomerular filtration rate (eGFR), ≤30ml/min/1.73m2 (max 1 month old)
- •The presence of a mechanical assist device
- •Use of inotropic drugs (dopamine, dobutamine, (nor)adrenaline, and milrinon)
- •Scheduled for mechanical assist device or heart transplant
- •Other non-cardiac conditions with limited life expectancy (≤ duration of the study)
- •Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
结局指标
主要结局
The primary endpoint is the composite of (repeated) HF hospitalizations, (repeated) urgent HF hospital visits and cardiovascular death.
The primary endpoint is the composite of (repeated) HF hospitalizations, (repeated) urgent HF hospital visits and cardiovascular death.
次要结局
- All-cause mortality
- Cardiovascular death.
- (Repeated) HF hospitalization
- (repeated) urgent HF hospital visits
- Cost-effectiveness.
- All-cause hospitalizations.
- Unscheduled cardiovascular hospital visits.
- Days alive out of hospital.
- Quality of Life.
- Heart rate in both AF and sinus rhythm.
- To assess side effects (including SUSARs) associated with study medication.
- Initiation of (recurrence of) AF in patients with sinus rhythm at baseline.
- Proteomics and validating hits in elisa's
- Conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline
研究者
Ester Maas
Scientific
Universitair Medisch Centrum Groningen
研究点 (1)
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