Preventing heart failure in cancer survivors through a guided management plan
Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
This study is testing a special management plan to see if it can help cancer survivors over 55 who had chemotherapy more than five years ago lower their risk of heart failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 685 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Baker Heart and Diabetes Institute Academic / other |
| Drugs / interventions | Trastuzumab, sunitinib, chemotherapy |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT04962711 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to identify and reduce the risk of heart failure in cancer survivors over 55 years old who received chemotherapy more than five years ago. Participants will be randomized to a cardio-oncology disease management plan (CO-DMP) that includes surveillance imaging for subclinical left ventricular dysfunction, clinical reviews for optimal risk factor control, and exercise interventions over six months. After this period, those receiving usual care will crossover to the CO-DMP for an additional six months. The study seeks to demonstrate the feasibility of this approach in reducing heart failure risk factors among long-term cancer survivors.
Who should consider this trial
Good fit: Ideal candidates are cancer survivors over 55 years old who received potentially toxic chemotherapy more than ten years ago.
Not a fit: Patients with a history of heart failure, significant valvular disease, or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of heart failure in cancer survivors, improving their long-term health outcomes.
How similar studies have performed: Previous studies have shown promise in similar approaches to managing heart health in cancer survivors, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Melbourne, Victoria
- Baker Heart and Diabetes Institute — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Thomas H Marwick, MD,PhD,MPH — Baker Heart and Diabetes Institute
- Study coordinator: Joel Smith
- Email: joel.smith@baker.edu.au
- Phone: +61385321962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.