Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
Recruiting · NCT04962711 · Interventional (participants receive a specific treatment) · Lead sponsor: Baker Heart and Diabetes Institute
View the official record on ClinicalTrials.gov →Interventions studied
Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)Usual care
What this trial is about
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.
Who can take part
Age range
40 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Baker Heart and Diabetes Institute - Melbourne, Victoria, Australia