Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
- Conditions
- Heart Failure
- Registration Number
- NCT04962711
- Lead Sponsor
- Baker Heart and Diabetes Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 840
Inclusion Criteria:<br><br> 1. History of cancer > 10 years ago<br><br> 2. Have received potentially toxic chemotherapy Anthracycline (any dose) Trastuzumab<br> (Herceptin) in breast-cancer with the HER2 mutation OR Tyrosine kinase inhibitors<br> (e.g. sunitinib) OR Left chest radiotherapy<br><br>Exclusion Criteria:<br><br> 1. Ejection fraction at baseline echo <50%<br><br> 2. Valvular stenosis or regurgitation of >moderate severity<br><br> 3. History of previous heart failure (baseline New York Heart Association (NYHA)<br> classification >2)<br><br> 4. Systolic BP <110 mmHg<br><br> 5. Pulse <60/minute if not on beta blocker<br><br> 6. Inability to acquire interpretable images (identified from baseline echo)<br><br> 7. Contraindications to beta blockers or angiotensin-converting enzyme inhibitors<br><br> 8. Oncologic (or other) life expectancy <12 months or any other medical condition<br> (including pregnancy) that results in the belief (deemed by the Chief Investigators)<br> that it is not appropriate for the patient to participate in this trial<br><br> 9. Already taking both angiotensin converting enzyme inhibitors/angiotensin receptor<br> blockers and beta blockers, or intolerance (or allergy) to both.<br><br> 10. Unable to provide written informed consent to participate in this study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in exercise capacity
- Secondary Outcome Measures
Name Time Method Medication adherence;Neuromuscular strength;Endurance