Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start: 2025-09-26
Primary completion:
Study completion finish:
Study type
SCREENING
Phase
- NA
Study ID
NCT04962711
Intervention or treatment
OTHER: Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)
OTHER: Usual care
Conditions
- Heart Failure
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Baker Heart and Diabetes Institute
Select from list below to view details:
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Baker Heart and Diabetes Institute
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Heart failure intervention ( Cardio-Oncology Disease Management Plan (CO-DMP)
| Other: Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP) |
ACTIVE_COMPARATOR: Usual care
| Other: Usual care |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in exercise capacity | Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up. | Over a period of 6 months |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence | proportion of ACEi and beta blocker tablets taken | Over a period of 6 months |
| Neuromuscular strength | Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer | Over a period of 6 months |
| Endurance | Increase in total exercise duration. | Over a period of 6 months |
| Left ventricular function | Change in global longitudinal strain (GLS) using echocardiographic speckle-tracking | Over a period of 6 months |
References
Clinical Trials Gov: Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)Other trials to consider
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