An interventional study of Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP) and Usual care in Heart Failure, sponsored by Baker Heart and Diabetes Institute. Recruiting at 1 site in Australia. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Baker Heart and Diabetes Institute · Not applicable, Interventional, and Screening
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.
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.
Exclusion Criteria:
1. Optimization of pharmacotherapy: Cardioprotection with angiotensin-converting enzyme inhibitor (ACEi, Ramipril) and beta blocker (Metoprolol).Participants will be initially treated with ramipril at a dose of 1.25 or 2.5mg (according to baseline systemic arterial pressure), once or twice a day, and gradually up-titrated to 10mg/day, or to the maximal-tolerated dose. In patients receiving at least 2.5mg/day of ramipril, metoprolol will be started at an initial dose of 50 (25mg twice a day) and progressively up-titrated to the maximal dose of 100mg/day. Patients will be reviewed every 2 weeks during the up titration phase. 2. Exercise intervention: Individualized training program provided by an exercise physiologist.
Other: Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)
Provided by participants' usual healthcare professional(s), guided by a brochure regarding optimal risk factor management addressing hypertension, lipids, alcohol intake and tobacco use.
Other: Usual care
A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
provided by participants' usual healthcare professional(s)
Change in exercise capacity
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.
Time frame: Over a period of 6 months
Medication adherence
proportion of ACEi and beta blocker tablets taken
Time frame: Over a period of 6 months
Neuromuscular strength
Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer
Time frame: Over a period of 6 months
Endurance
Increase in total exercise duration.
Time frame: Over a period of 6 months
Left ventricular function
Change in global longitudinal strain (GLS) using echocardiographic speckle-tracking
Time frame: Over a period of 6 months
Plan to share: No — Data sharing based available on application to the study PI
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Baker Heart and Diabetes Institute