Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)

Обзор

This is a prospective study in which a process of identifying and reducing heart failure (HF) risk will be applied to cancer survivors \>55 years old with chemotherapy \>5 years ago. The overall goal of this study to identify the feasibility and value of risk-guided cardiac rehabilitation (exercise, risk factor modification, and behavioural support) as a component of survivorship care.

Подробное описание

Participants enrolled in this study will be randomized to cardio-oncology disease management plan ( CO-DMP) that involves the use of surveillance imaging to detect subclinical left ventricular dysfunction (LVD), clinical review to ensure optimal risk factor control and cardio-protection and exercise/sedentariness intervention. The intervention will be delivered over a period of 6 months. Usual care patients will then cross over the CO-DMP for 6 months. The outcome from this study will show that subclinical LVD is more common among long term cancer survivors, and a CO-DMP is feasible in reducing HF risk factors in this sub group of survivors.

Вмешательства

• Другое Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)
  A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
• Другое Usual care
  provided by participants' usual healthcare professional(s)

Первичные конечные точки

• Change in exercise capacity [Срок оценки: Over a period of 6 months]

Вторичные конечные точки (4)

• Medication adherence [Срок оценки: Over a period of 6 months]
• Neuromuscular strength [Срок оценки: Over a period of 6 months]
• Endurance [Срок оценки: Over a period of 6 months]
• Left ventricular function [Срок оценки: Over a period of 6 months]

Критерии участия

Критерии включения

• History of cancer > 10 years ago
• Have received potentially toxic chemotherapy Anthracycline (any dose) Trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR Tyrosine kinase inhibitors (e.g. sunitinib) OR Left chest radiotherapy

Критерии исключения

• Ejection fraction at baseline echo <50%
• Valvular stenosis or regurgitation of >moderate severity
• History of previous heart failure (baseline New York Heart Association (NYHA) classification >2)
• Systolic BP <110 mmHg
• Pulse <60/minute if not on beta blocker
• Inability to acquire interpretable images (identified from baseline echo)
• Contraindications to beta blockers or angiotensin-converting enzyme inhibitors
• Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
• Already taking both angiotensin converting enzyme inhibitors/angiotensin receptor blockers and beta blockers, or intolerance (or allergy) to both.
• Unable to provide written informed consent to participate in this study

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

Австралия · 1 центр

• Baker Heart and Diabetes Institute — Melbourne

Публикации

• Wong J, Smith J, Soh CH, Howden E, Talbot JS, Nolan M, Whitmore K, Wright L, Sherriff AG, Sivaraj E, Wheeler G, Wiltshire K, Campbell P, Ramkumar S, Tam C, Marwick TH. Risk-guided disease management to prevent heart failure in adult cancer survivors of previous cardiotoxic cancer treatments: Baseline results of the REDEEM trial. Am Heart J. 2026 Feb;292:107277. doi: 10.1016/j.ahj.2025.09.009. Epub PMID 40967296

Идентификаторы

NCT: NCT04962711 · 82/21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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