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Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
RECRUITINGN/ASponsored by Baker Heart and Diabetes Institute
Actively Recruiting
PhaseN/A
SponsorBaker Heart and Diabetes Institute
Started2023-03-30
Est. completion2025-12-31
Eligibility
Age40 Years – 85 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04962711
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
Age: 40 Years – 85 YearsHealthy volunteers accepted
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
Conditions2
Heart DiseaseHeart Failure
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Actively Recruiting
PhaseN/A
SponsorBaker Heart and Diabetes Institute
Started2023-03-30
Est. completion2025-12-31
Eligibility
Age40 Years – 85 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04962711