CClinicalTrials.gg
RecruitingNCT04962711Updated May 31, 2025

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

An interventional study of Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP) and Usual care in Heart Failure, sponsored by Baker Heart and Diabetes Institute. Recruiting at 1 site in Australia. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Baker Heart and Diabetes Institute · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
685
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure

Browse trials for

03

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
685 participants (estimated)

Study arms

  • Experimental
    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.

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

  • Active comparator
    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.

    Other: Usual care

Interventions

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

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

  • OtherUsual care

    provided by participants' usual healthcare professional(s)

05

What researchers measure

Primary outcomes

  1. Change in exercise capacity

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

    Time frame: Over a period of 6 months

Secondary outcomes

  1. Medication adherence

    proportion of ACEi and beta blocker tablets taken

    Time frame: Over a period of 6 months

  2. Neuromuscular strength

    Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer

    Time frame: Over a period of 6 months

  3. Endurance

    Increase in total exercise duration.

    Time frame: Over a period of 6 months

  4. Left ventricular function

    Change in global longitudinal strain (GLS) using echocardiographic speckle-tracking

    Time frame: Over a period of 6 months

06

Study locations

1 of 1 sites recruiting
  • Baker Heart and Diabetes Institute
    Melbourne, Victoria 3004, Australia
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Data sharing based available on application to the study PI

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04962711
Lead sponsor
Baker Heart and Diabetes Institute
Responsible party
Sponsor
First posted
Jul 15, 2021
Start date
Mar 30, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 31, 2025

Study contacts

Joel Smith
Contact
joel.smith@baker.edu.au
+61385321962
Thomas H Marwick, MD,PhD,MPH
Contact
tom.marwick@baker.edu.au
+61385321550
Thomas H Marwick, MD,PhD,MPH
principal investigator · Baker Heart and Diabetes Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion