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Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
NCT04962711 · Baker Heart and Diabetes Institute
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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
Study design
Enrollment target: 685 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-03-30
Estimated completion: 2025-12-31
Last updated: 2025-05-31
Interventions
Other: Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)Other: Usual care
Primary outcomes
- • Change in exercise capacity (Over a period of 6 months)
Sponsor
Baker Heart and Diabetes Institute · other
Contacts & investigators
ContactJoel Smith · contact · joel.smith@baker.edu.au · +61385321962
ContactThomas H Marwick, MD,PhD,MPH · contact · tom.marwick@baker.edu.au · +61385321550
InvestigatorThomas H Marwick, MD,PhD,MPH · principal_investigator, Baker Heart and Diabetes Institute
All locations (1)
Baker Heart and Diabetes InstituteRecruiting
Melbourne, Victoria, Australia