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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

SCREENING

Phase

Trial ID

NCT04962711

Intervention or treatment

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

OTHER: Usual care

Conditions

• 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

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Find a site

Closest Location:

Baker Heart and Diabetes Institute

Research sites nearby

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Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia

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/Arm	Intervention/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)

Participant Group/Arm

Intervention/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 Measure	Primary Outcome Description	Primary Outcome Time Frame
Change in exercise capacity	Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.	Over a period of 12 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Medication adherence	proportion of ACEi and beta blocker tablets taken	Over a period of 12 months
Neuromuscular strength	Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer	Over a period of 12 months
Endurance	Increase 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)