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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    840
  • sponsor
    Baker Heart and Diabetes Institute
Updated on 13 July 2022
cancer
heart failure
rehabilitation program
HER2
Accepts healthy volunteers

Summary

This is a prospective study in which a process of identifying and reducing heart failure (HF) risk will be applied to cancer survivors >65 years old with chemotherapy >10 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.

Description

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 12 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.

Details
Condition Heart Failure
Treatment Usual Care, Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)
Clinical Study IdentifierNCT04962711
SponsorBaker Heart and Diabetes Institute
Last Modified on13 July 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note