Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan

Официальное название

Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (Treat HF)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Sacubitril-valsartan
  Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
• Препарат Valsartan
  Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
• Препарат Carvedilol
  Administered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily)

Первичные конечные точки

• 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. [Срок оценки: 24 Months]
• 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. [Срок оценки: 27 Months]
• 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. [Срок оценки: 27 Months]

Вторичные конечные точки (12)

• Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 60 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Baseline, 90 Days, 365 days]

Критерии участия

Критерии включения

• Age </= 39 years old at time of cancer diagnosis
• Clinical records adequate to determine diagnosis and treatment regimen
• Previous anthracycline chemotherapy
• Global longitudinal strain <18% and/or
• Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal but >/=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).

Критерии исключения

• -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-19.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT05194111 · MCC-21-18830 · HM20023601

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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