Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 685
- Locations
- 2
- Primary Endpoint
- Change in exercise capacity
Study Overview
Brief 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.
Detailed Description
Participants enrolled in this study will be randomized to cardio-oncology disease management plan ( CO-DMP) that involves the use of surveillance imaging to detect subclinical left ventricular dysfunction (LVD), clinical review to ensure optimal risk factor control and cardio-protection and exercise/sedentariness intervention. The intervention will be delivered over a period of 6 months. Usual care patients will then cross over the CO-DMP for 6 months. The outcome from this study will show that subclinical LVD is more common among long term cancer survivors, and a CO-DMP is feasible in reducing HF risk factors in this sub group of survivors.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes assessor will receive study data based on pooled de identified dataset.
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in exercise capacity
Time Frame: Over a period of 6 months
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.
Secondary Outcomes
- Medication adherence(Over a period of 6 months)
- Neuromuscular strength(Over a period of 6 months)
- Endurance(Over a period of 6 months)
- Left ventricular function(Over a period of 6 months)