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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962711
• Other study ID #: 82/21
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Baker Heart and Diabetes Institute
• Contact: Joel Smith
• Phone: +61385321962
• Email: joel.smith[@]baker.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• Usual care
provided by participants' usual healthcare professional(s)

Locations

Country	Name	City	State
Australia	Baker Heart and Diabetes Institute	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Baker Heart and Diabetes Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in exercise capacity	Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.	Over a period of 12 months
Secondary	Medication adherence	proportion of ACEi and beta blocker tablets taken	Over a period of 12 months
Secondary	Neuromuscular strength	Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer	Over a period of 12 months
Secondary	Endurance	Increase in total exercise duration.	Over a period of 12 months