Preventing heart failure in cancer survivors through a guided management plan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study aims to identify and reduce the risk of heart failure in cancer survivors over 55 years old who received chemotherapy more than five years ago. Participants will be randomized to a cardio-oncology disease management plan (CO-DMP) that includes surveillance imaging for subclinical left ventricular dysfunction, clinical reviews for optimal risk factor control, and exercise interventions over six months. After this period, those receiving usual care will crossover to the CO-DMP for an additional six months. The study seeks to demonstrate the feasibility of this approach in reducing heart failure risk factors among long-term cancer survivors.

Why it matters

Who can join: the full rules

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:

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

Where it's running

• Baker Heart and Diabetes Institute
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Thomas H Marwick, MD,PhD,MPH — Baker Heart and Diabetes Institute
• Study coordinator: Joel Smith
• Email: joel.smith@baker.edu.au
• Phone: +61385321962

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.