Clinical trial NCT04962711: Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
Official title: Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 685
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to CO-DMP or usual care
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in exercise capacity
timeFrame: Over a period of 6 months
Secondary outcomes:
measure: Medication adherence
timeFrame: Over a period of 6 months
measure: Neuromuscular strength
timeFrame: Over a period of 6 months
measure: Endurance
timeFrame: Over a period of 6 months
measure: Left ventricular function
timeFrame: Over a period of 6 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker Heart and Diabetes Institute
state: Victoria
Study officials:
affiliation: Baker Heart and Diabetes Institute
name: Thomas H Marwick, MD,PhD,MPH
role: PRINCIPAL_INVESTIGATOR
References: