Heart FailureNCT04962711
Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
A study testing Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP) in people with Heart Failure, run by Baker Heart and Diabetes Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 685 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004
Thomas Marwick, +61385321550, tom.marwick@baker.edu.au
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP), Usual care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Usual careOther
provided by participants' usual healthcare professional(s)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise capacity
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.
Measured: Over a period of 6 months
Secondary outcomes (4)
Medication adherence
proportion of ACEi and beta blocker tablets taken
Measured: Over a period of 6 months
Neuromuscular strength
Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer
Measured: Over a period of 6 months
Endurance
Increase in total exercise duration.
Measured: Over a period of 6 months
Left ventricular function
Change in global longitudinal strain (GLS) using echocardiographic speckle-tracking
Measured: Over a period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start30 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to CO-DMP or usual care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 685 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas H Marwick, MD,PhD,MPH, Principal investigator, Baker Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962711
- Sponsor's protocol ID
- 82/21
- Status last verified
- May 2025
- First submitted
- 22 Jun 2021
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing based available on application to the study PI
Publications
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.
PubMed 40967296
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
- ClinicalTrials.gov ID
- NCT04962711
- Acronym / sponsor ID
- 82/21
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 685 participants (estimated)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization to CO-DMP or usual care
| Arm | Type | Receives |
|---|---|---|
| Heart failure intervention ( Cardio-Oncology Disease Management Plan (CO-DMP) | Experimental | Other: 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 | Active comparator | Other: Usual careProvided by participants' usual healthcare professional(s), guided by a brochure regarding optimal risk factor management addressing hypertension, lipids, alcohol intake and tobacco use. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Heart failure intervention ( Cardio-Oncology Disease Management Plan (CO-DMP) |
| Usual careprovided by participants' usual healthcare professional(s) | Other | Usual care |
Primary outcome
Change in exercise capacity
Time frame: Over a period of 6 months
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.
4 secondary outcomes
Medication adherence
Time frame: Over a period of 6 months
Neuromuscular strength
Time frame: Over a period of 6 months
Endurance
Time frame: Over a period of 6 months
Left ventricular function
Time frame: Over a period of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 40967296Wong 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.
- Individual participant dataSharing planned: No. Data sharing based available on application to the study PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas H Marwick, MD,PhD,MPH principal investigator
Baker Heart and Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP) in people with Heart Failure, run by Baker Heart and Diabetes Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joel Smith (+61385321962, joel.smith@baker.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exercise capacity (time frame: Over a period of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04962711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.