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Recruiting NCT04962711

NCT04962711 Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)

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Clinical Trial Summary
NCT ID NCT04962711
Status Recruiting
Phase
Sponsor Baker Heart and Diabetes Institute
Condition Heart Failure
Study Type INTERVENTIONAL
Enrollment 685 participants
Start Date 2023-03-30
Primary Completion 2025-12-31

Trial Parameters

Condition Heart Failure
Sponsor Baker Heart and Diabetes Institute
Study Type INTERVENTIONAL
Phase N/A
Enrollment 685
Sex ALL
Min Age 40 Years
Max Age 85 Years
Start Date 2023-03-30
Completion 2025-12-31
Interventions
Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)Usual care

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Brief Summary

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.

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 co

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