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

Not Applicable

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT04962711
• Lead Sponsor: Baker Heart and Diabetes Institute

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 Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-15
• Study Start: 2023-03-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 685

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in exercise capacity	Over a period of 6 months	Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.

Secondary Outcome Measures

Name	Time	Method
Left ventricular function	Over a period of 6 months	Change in global longitudinal strain (GLS) using echocardiographic speckle-tracking
Medication adherence	Over a period of 6 months	proportion of ACEi and beta blocker tablets taken
Neuromuscular strength	Over a period of 6 months	Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer
Endurance	Over a period of 6 months	Increase in total exercise duration.

Trial Locations

Locations (1)

Baker Heart and Diabetes Institute; 🇦🇺 Melbourne, Victoria, Australia