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Набира участници Не е приложимо NCT04962711

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

Не е приложима фаза (напр. обсервационно)
Заболявания: Heart Failure

Спонсор: Baker Heart and Diabetes Institute

Налично на: БГ
Обобщение
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.
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.
Кой може да участва
Inclusion Criteria: 1. History of cancer \> 10 years ago 2. 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 Exclusion Criteria: 1. Ejection fraction at baseline echo \<50% 2. Valvular stenosis or regurgitation of \>moderate severity 3. History of previous heart failure (baseline New York Heart Association (NYHA) classification \>2) 4. Systolic BP \<110 mmHg 5. Pulse \<60/minute if not on beta blocker 6. Inability to acquire interpretable images (identified from baseline echo) 7. Contraindications to beta blockers or angiotensin-converting enzyme inhibitors 8. 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 9. Already taking both angiotensin converting enzyme inhibitors/angiotensin receptor blockers and beta blockers, or intolerance (or allergy) to both. 10. Unable to provide written informed consent to participate in this study
Места на провеждане 1
Австралия (1)
Baker Heart and Diabetes Institute
Melbourne , Victoria
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
40 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
30.03.2023
Крайна дата
31.12.2025
Регистрационен номер
NCT04962711
Източник
anzctr
Запитване за медицински туризъм

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