TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,973
- 试验地点
- 60
- 主要终点
- All-cause Mortality, as Measured by Follow-up Phone Call or NDI
研究概览
简要总结
TRANSFORM-HF is a large-scale, pragmatic, randomized, unblinded clinical effectiveness study comparing torsemide versus furosemide as treatment for heart failure. Approximately 6,000 patients with heart failure will be enrolled. The primary objective of the TRANSFORM-HF study is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized.
详细描述
- This study will be a randomized, unblinded, two-arm, multi-center clinical trial of patients with heart failure who are hospitalized. Heart failure need not be the reason for hospitalization. Patients will be randomized 1:1 to either oral torsemide OR oral furosemide prior to hospital discharge. Oral dosing of torsemide compared to furosemide will be 1mg:2mg. The specific loop diuretic dose will be at the discretion of the treating physician with the above noted conversion.
- Trial enrollment occurs before hospital discharge, at the discretion of the healthcare provider.
- As appropriate, adherence to the randomized medication will be encouraged during the remainder of hospitalization and will continue post-discharge. Patients will receive follow-up per standard care without any additional study-specific visits.
- Patients will have 30-day, 6-month and 12-month follow-up phone contacts for assessments of vital status, interval hospitalizations, adherence, and quality of life. "Central follow-up" and collection of hospital discharge summaries via IRB-approved mechanisms. Subsets of patients enrolled early in the study have additional phone contacts beyond 12 months, up to 30 months, at six month intervals, to document vital status.
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
- •Patient hospitalized (≥ 24 hours or over a change in calendar date) with worsening of chronic heart failure, or new diagnosis of heart failure AND meets one of the following criteria:
- •Has a left ventricular ejection fraction (EF) ≤40% within 24 months prior to and including index hospitalization by any method (with most recent value used to determine eligibility)
- •Has an elevated natriuretic peptide level (either NT-pro-B-type natriuretic peptide or B-type natriuretic peptide) during index hospitalization as measured by local laboratory (with most recent value used to determine eligibility)
- •Plan for a daily outpatient oral loop diuretic regimen upon hospital discharge with anticipated need for long-term loop diuretic use
- •≥ 18 years of age
- •Signed informed consent
排除标准
- •End-stage renal disease requiring renal replacement therapy
- •Inability or unwillingness to comply with the study requirements
- •History of heart transplant or actively listed for heart transplant
- •Implanted left ventricular assist device or implant anticipated <3 months
- •Pregnant or nursing women
- •Malignancy or other non-cardiac condition limiting life expectancy to <12 months
- •Known hypersensitivity to furosemide, torsemide, or related agents
研究组 & 干预措施
Torsemide
Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.
干预措施: Torsemide (Drug)
Furosemide
Oral dosing of torsemide compared to furosemide will be 1mg:2-4mg.
For patients receiving loop diuretics other than furosemide, conversion to furosemide equivalents will be as follows:
1 mg oral torsemide = 2-4 mg oral furosemide
1 mg oral or intravenous bumetanide = 40 mg oral furosemide
干预措施: Furosemide (Drug)
结局指标
主要结局
All-cause Mortality, as Measured by Follow-up Phone Call or NDI
时间窗: up to 30 months
Death information was obtained from the Call Center through 30 months for patients 1-500, through 24 months for patients 501-1000, through 18 months for patients 1001-1500, and through 12 months for the remaining patients (except those who were randomized \< 12 months when the study was stopped by the DSMB). Also death information was obtained through searches of the 2018-2021 National Death Index (NDI) database.
次要结局
- All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death)(30 days)
- Total Re-hospitalizations, as Measured by Follow-up Phone Call(up to 12 months)
- Change in Health-related Quality of Life (QOL), as Measured by Follow-up Phone Call(Baseline, 1 month, 6 months, 12 months)
- Symptoms of Depression as Measured by the Patient Health Questionnaire-2 (PHQ-2)(Month 1, month 6, month 12)