Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (Treat HF)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Determine feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
研究概览
简要总结
To determine feasibility of recruitment and tolerability of treatment with sacubitril-valsartan among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
详细描述
The current study will test the hypothesis that among adult age survivors of cancer diagnosed at age < 39 years treatment of Stage B heart failure with sacubitril-valsartan is feasible and safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Cardiac magnetic resonance studies will be de-identified and assigned a study number. The identification key will not be available to cardiac magnetic resonance readers so that they are blinded to treatment allocation
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Age \/=40% on echocardiogram or cardiac magnetic resonance imaging (MRI)
- •* No symptoms of heart failure (shortness of breath, fatigue, swelling). Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
排除标准
- •-Age <18 years
- •Inability to obtain consent from patient or legally authorized representative
- •Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent compliance with study instructions
- •Limited English or Spanish proficiency that in the opinion of the investigator may prevent understanding the content of the informed consent form or safely completing the study procedures
- •Participation in another concurrent intervention study within 30 days or treatment with an investigational drug within 5 half-lives prior to randomization
- •Greater than mild mitral or aortic valve regurgitation/stenosis known pre-cancer therapy
- •Severe kidney disease (glomerular filtration rate (GFR) <30 milliliters (mL)/minute (min)/1.73 meters squared (m2))
- •Chronic hyperkalemia (>5millimoles per liter (mmol/L))
- •Evidence of Coronavirus (COVID-19) within the last 60 days or recent (21 days) exposure to close personal contact with COVID-
- •Greater than moderate tricuspid or pulmonary valve regurgitation/stenosis known pre-cancer therapy
- •Hemodynamically significant congenital heart disease in the opinion of the investigator (not including patent foramen ovale (PFO)/small atrial septal defect (ASD) or small ventricular septal defect (VSD))
- •Greater than moderate pericardial effusion
- •Constrictive cardiomyopathy diagnosed pre-cancer therapy
- •Family history of genetic cardiomyopathy
- •Evidence of infiltrative cardiomyopathy
- •Symptomatic heart disease based on New York Heart Association (NYHA) classification
- •Allergy to valsartan or sacubitril
- •Inability to complete cardiac magnetic resonance (CMR) or 6-minute walk test
- •Inability to measure non-invasive blood pressure and heart rate in the ambulatory/home setting
- •Pregnant/lactating
- •History of severe hypersensitivity reactions to gadolinium-based contrast agents (will perform limited cardiac imaging without contrast)
- •Concomitant use of other angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), aliskiren, non-steroidal anti-inflammatories (NSAIDs) or lithium or the inability to stop these medications for the study
研究组 & 干预措施
Arm 3: Carvedilol
Administered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily)
干预措施: Carvedilol (Drug)
Arm 1: Sacubitril-valsartan
Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
干预措施: Sacubitril-valsartan (Drug)
Arm 2: Valsartan
Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
干预措施: Valsartan (Drug)
结局指标
主要结局
Determine feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
时间窗: 24 Months
Number of participants screened for the clinical trial.
Determine the feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
时间窗: 27 Months
Number of participants enrolled on the trial
Determine tolerability of treatment with sacubitril-valsartan among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
时间窗: 27 Months
Number of participants that complete therapy
次要结局
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(30 Days after start of treatment)
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(180 Days)
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(270 Days)
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(365 Days)
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(Baseline, Day 60 days, 365 Days)
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(Baseline, 90 Days, 365 Days)
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(Baseline, 90 Days, 365 days)
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(90 Days)
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(27 Months)
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(30 Days)
- Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.(60 Days)