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

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 40 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-03-30

    Primary completion: 2025-12-31

    Study completion finish: 2025-12-31

    study type

    Study type

    SCREENING

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04962711

    Intervention or treatment

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

    OTHER: Usual care

    Conditions

    • Heart Failure
    Image related to Heart Failure
    • Condition: Heart Failure

    • OTHER: Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP) and other drugs

    • Melbourne, Victoria, Australia

    • Sponsor: Baker Heart and Diabetes Institute

    Find a site

    Closest Location:

    Baker Heart and Diabetes Institute

    Research sites nearby

    Select from list below to view details:

    • Baker Heart and Diabetes Institute

      Melbourne, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    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)
    • A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
    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
    • provided by participants' usual healthcare professional(s)

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change in exercise capacityCardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.Over a period of 12 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Medication adherenceproportion of ACEi and beta blocker tablets takenOver a period of 12 months
    Neuromuscular strengthMaximal isometric grip strength (kg) assessed using a digital grip strength dynamometerOver a period of 12 months
    EnduranceIncrease in total exercise duration.Over a period of 12 months

    Frequently Asked Questions

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    References

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

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