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

NCT ID: NCT04962711

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 685 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2025-12-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)

Intervention Type: OTHER

A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

provided by participants' usual healthcare professional(s)

Interventions

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.

Intervention Type: OTHER

Usual care

provided by participants' usual healthcare professional(s)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baker Heart and Diabetes Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas H Marwick, MD,PhD,MPH

Role: PRINCIPAL_INVESTIGATOR

Baker Heart and Diabetes Institute

Locations

Baker Heart and Diabetes Institute

Melbourne, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Joel Smith

Role: CONTACT

joel.smith@baker.edu.au

+61385321962

Thomas H Marwick, MD,PhD,MPH

Role: CONTACT

tom.marwick@baker.edu.au

+61385321550

Facility Contacts

Thomas Marwick

Role: primary

tom.marwick@baker.edu.au

+61385321550

References

Wong J, Smith J, Soh CH, Howden E, Talbot JS, Nolan M, Whitmore K, Wright L, Sherriff AG, Sivaraj E, Wheeler G, Wiltshire K, Campbell P, Ramkumar S, Tam C, Marwick TH. Risk-guided disease management to prevent heart failure in adult cancer survivors of previous cardiotoxic cancer treatments: Baseline results of the REDEEM trial. Am Heart J. 2025 Sep 16;292:107277. doi: 10.1016/j.ahj.2025.09.009. Online ahead of print.

Reference Type: DERIVED

PMID: 40967296 (View on PubMed)

Other Identifiers

82/21

Identifier Type: -

Identifier Source: org_study_id