RecruitingNot ApplicableNCT04962711
Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
Sponsor
Baker Heart and Diabetes Institute
Enrollment
685 participants
Start Date
Mar 30, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 40 YearsMax Age: 85 Years
Inclusion Criteria2
- 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 Criteria10
- 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
Interventions
OTHERHeart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)
A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
OTHERUsual care
provided by participants' usual healthcare professional(s)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04962711
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