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NCT Number: NCT04962711

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

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.

Recruiting

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location status: Recruiting

Location contact

Thomas Marwick

CONTACT

[email protected]

+61385321550

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 Care

Other

provided by participants' usual healthcare professional(s)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Medication adherence

    Time frame: Over a period of 6 months

    proportion of ACEi and beta blocker tablets taken

  2. Neuromuscular strength

    Time frame: Over a period of 6 months

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

  3. Endurance

    Time frame: Over a period of 6 months

    Increase in total exercise duration.

  4. Left ventricular function

    Time frame: Over a period of 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Joel Smith

CONTACT

[email protected]

+61385321962

Thomas H Marwick, MD,PhD,MPH

CONTACT

[email protected]

+61385321550

Sponsors and collaborators

Lead sponsor

Baker Heart and Diabetes Institute

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2021
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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