Heart Failure With Reduced Ejection Fraction Polypill Implementation Strategy in Sri Lanka: A Pilot Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Adherence to study procedures
研究概览
简要总结
The primary objective of this trial is to see if the research team can successfully recruit participants and carry out study related procedures in Sri Lanka. This will help the research team plan and execute a future large-scale trial in Sri Lanka.
The secondary objective is to assess whether a polypill for patients with heart failure with reduced ejection fraction (a type of heart condition) may help patients adhere to medications without an increase in serious adverse events.
An exploratory objective is to understand the process of implementation.
Participants will be randomly assigned to one of two groups, intervention or usual care. The intervention group will be given four guideline-recommended medications for heart failure with reduced ejection fraction, combined in one over-encapsulated pill, with three dose strength options (at the discretion of their treating physician). Both groups will be observed over 4-weeks of follow-up to assess their medication adherence, clinical symptoms, laboratory measures, health related quality of life, and need for medication adjustment amongst other measures.
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
- None
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
- •Adults (age ≥18 years old)
- •Diagnosis of heart failure with reduced ejection fraction (HFrEF) including clinical symptoms or clinical signs or natriuretic peptide elevation AND echocardiographic or other evidence of reduced ejection fraction (EF 40%)
- •New York Heart Association Class II, III, or IV symptoms
排除标准
- •Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others).
- •Significant renal impairment (estimated glomerular filtration rate <=30 mL/min/1.73 m2 or creatinine clearance <=30mL/min).
- •Raised serum potassium >5 mEq/L.
- •Symptomatic hypotension or systolic BP <100 mmHg as per the average of last 2 of the 3 measurements at visit
- •Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit
- •Cardiogenic shock and/or current use of inotropes.
- •Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrollment.
- •Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).
- •Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary physician could interfere with the conduct of the study including outcome assessment.
- •Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.
- •Participant's responsible physician believes it is not appropriate for participant to participate in the study.
- •Inability or unwillingness to provide written informed consent.
- •Involvement in the planning and/or conduct of the study.
- •Unable to complete study procedures and/or plan to move out of the study site area in the next 2 months.
研究组 & 干预措施
Comparator (control) arm
Participants in the comparator control arm will receive usual care, as per their physician's discretion.
干预措施: Comparator Arm (Other)
Study Intervention arm
Participants in the intervention group will be provided the HFrEF polypill by the study.
干预措施: HFrEF Polypill (Drug)
结局指标
主要结局
Adherence to study procedures
时间窗: 0 - 14 weeks, baseline to study end
Adherence to study procedures based on completion of the following: completion of study-related procedures (screening, randomization, study drug allocation, follow-up procedures, retention, and outpatient transition).
Feasibility of recruitment
时间窗: 0 - 10 weeks, start of enrollment to completion of participant enrollment
Feasibility of recruitment based on completion of the following: recruitment of up to 40 participants at a rate of 4 participants per week.
次要结局
- Adherence to overall and individual components of GDMT(4 weeks)
- Serious Adverse Events(From enrollment to the end of treatment at 4 weeks)
- Mean Change in Serum Potassium(4 weeks)
- Withdrawals due to Adverse Events(From enrollment to the end of treatment at 4 weeks)
- Adverse Events of Special Interest(From enrollment to the end of treatment at 4 weeks)
- Change in Serum Creatinine(4 weeks)