NCT04962711

Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 685 (estimated)
• Sponsor: Baker Heart and Diabetes Institute · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)	A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
OTHER	Usual care	provided by participants' usual healthcare professional(s)

Timeline

• Start date: 2023-03-30
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-07-15
• Last updated: 2025-05-31

Locations

1 site across 1 country: Australia