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

NCT04962711 | Recruiting

• 1 other identifier: 82/21
• Study Type: interventional
• Target: 685
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in exercise capacity

  Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.

  Over a period of 6 months

Secondary Outcomes (4)

• Medication adherence

  Over a period of 6 months

• Neuromuscular strength

  Over a period of 6 months

• Endurance

  Over a period of 6 months

• Left ventricular function

  Over a period of 6 months

Study Arms (2)

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

EXPERIMENTAL

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)

Usual care

ACTIVE COMPARATOR

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

Interventions

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

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

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

Usual care OTHER

provided by participants' usual healthcare professional(s)

Usual care

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of cancer \> 10 years ago
• 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

You may not qualify if:

• Ejection fraction at baseline echo \<50%
• Valvular stenosis or regurgitation of \>moderate severity
• History of previous heart failure (baseline New York Heart Association (NYHA) classification \>2)
• Systolic BP \<110 mmHg
• Pulse \<60/minute if not on beta blocker
• Inability to acquire interpretable images (identified from baseline echo)
• Contraindications to beta blockers or angiotensin-converting enzyme inhibitors
• 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
• Already taking both angiotensin converting enzyme inhibitors/angiotensin receptor blockers and beta blockers, or intolerance (or allergy) to both.
• Unable to provide written informed consent to participate in this study

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead

Study Sites (1)

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

RECRUITING

Related Publications (1)

• 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. 2026 Feb;292:107277. doi: 10.1016/j.ahj.2025.09.009. Epub 2025 Sep 16.

  PMID: 40967296 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Thomas H Marwick, MD,PhD,MPH

  Baker Heart and Diabetes Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Smith

CONTACT

+61385321962; joel.smith@baker.edu.au

Thomas H Marwick, MD,PhD,MPH

CONTACT

+61385321550; tom.marwick@baker.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will receive study data based on pooled de identified dataset.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization to CO-DMP or usual care

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 15, 2021
• Study Start: March 30, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)