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NCT04962711Recruiting

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

Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
685 (estimated)
First submitted
22 Jun 2021
Start date
30 Mar 2023
Primary completion date
31 Dec 2025
Lead sponsor
Baker Heart and Diabetes Institute
NCT number
NCT04962711

What you commit to

  • Study type: Interventional
  • Planned participants: 685
  • From 30 Mar 2023 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of previous heart failure (baseline New York Heart Association (NYHA) classification \>2)
  • Contraindications to beta blockers or angiotensin-converting enzyme inhibitors

Other illness

  • 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.

Lab values

  • Ejection fraction at baseline echo \<50%

Other

  • Valvular stenosis or regurgitation of \>moderate severity
  • Systolic BP \<110 mmHg
  • Pulse \<60/minute if not on beta blocker
  • Inability to acquire interpretable images (identified from baseline echo)
  • Unable to provide written informed consent to participate in this study

Who the study is looking for

  • 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

Age in the registry: 40 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Baker Heart and Diabetes Institute
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.