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

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Other: Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP); Other: Usual care

• 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: 2023-09
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 840

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

Arm && Interventions

Group	Intervention	Description
Heart failure intervention ( Cardio-Oncology Disease Management Plan (CO-DMP)	Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)	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.
Usual care	Usual care	Provided by participants' usual healthcare professional(s), guided by a brochure regarding optimal risk factor management addressing hypertension, lipids, alcohol intake and tobacco use.

Primary Outcome Measures

Name	Time	Method
Change in exercise capacity	Over a period of 12 months	Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.

Secondary Outcome Measures

Name	Time	Method
Neuromuscular strength	Over a period of 12 months	Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer
Medication adherence	Over a period of 12 months	proportion of ACEi and beta blocker tablets taken
Endurance	Over a period of 12 months	Increase in total exercise duration.

Trial Locations

Locations (1)

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