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

Sponsor

Baker Heart and Diabetes Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04962711

Collaborator

(none)

840

Enrollment

Location

Arms

Anticipated Duration (Months)

46.7

Patients Per Site Per Month

Study Details

Study Description

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 >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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP) Other: Usual care	N/A

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

840 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomization to CO-DMP or usual careRandomization to CO-DMP or usual care

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes assessor will receive study data based on pooled de identified dataset.

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Heart failure intervention ( Cardio-Oncology Disease Management Plan (CO-DMP) Optimization of pharmacotherapy: Cardioprotection with angiotensin-converting enzyme inhibitor (ACEi, Ramipril) and beta blocker (Metoprolol).Participants will be initially treated with ramipril at a dose of 1.25 or 2.5mg (according to baseline systemic arterial pressure), once or twice a day, and gradually up-titrated to 10mg/day, or to the maximal-tolerated dose. In patients receiving at least 2.5mg/day of ramipril, metoprolol will be started at an initial dose of 50 (25mg twice a day) and progressively up-titrated to the maximal dose of 100mg/day. Patients will be reviewed every 2 weeks during the up titration phase. Exercise intervention: Individualized training program provided by an exercise physiologist.	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.
Active Comparator: Usual care Provided by participants' usual healthcare professional(s), guided by a brochure regarding optimal risk factor management addressing hypertension, lipids, alcohol intake and tobacco use.	Other: Usual care provided by participants' usual healthcare professional(s)

Arm

Intervention/Treatment

Experimental: Heart failure intervention ( Cardio-Oncology Disease Management Plan (CO-DMP)

Optimization of pharmacotherapy: Cardioprotection with angiotensin-converting enzyme inhibitor (ACEi, Ramipril) and beta blocker (Metoprolol).Participants will be initially treated with ramipril at a dose of 1.25 or 2.5mg (according to baseline systemic arterial pressure), once or twice a day, and gradually up-titrated to 10mg/day, or to the maximal-tolerated dose. In patients receiving at least 2.5mg/day of ramipril, metoprolol will be started at an initial dose of 50 (25mg twice a day) and progressively up-titrated to the maximal dose of 100mg/day. Patients will be reviewed every 2 weeks during the up titration phase. Exercise intervention: Individualized training program provided by an exercise physiologist.

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.

Active Comparator: Usual care

Provided by participants' usual healthcare professional(s), guided by a brochure regarding optimal risk factor management addressing hypertension, lipids, alcohol intake and tobacco use.

Other: Usual care

provided by participants' usual healthcare professional(s)

Outcome Measures

Primary Outcome Measures

Change in exercise capacity [Over a period of 12 months]
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.

Secondary Outcome Measures

Medication adherence [Over a period of 12 months]
proportion of ACEi and beta blocker tablets taken
Neuromuscular strength [Over a period of 12 months]
Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer
Endurance [Over a period of 12 months]
Increase in total exercise duration.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baker Heart and Diabetes Institute	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

Baker Heart and Diabetes Institute

Investigators

Principal Investigator: Thomas H Marwick, MD,PhD,MPH, Baker Heart and Diabetes Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Baker Heart and Diabetes Institute

ClinicalTrials.gov Identifier:

NCT04962711

Other Study ID Numbers:

82/21

First Posted:

Jul 15, 2021

Last Update Posted:

Jun 28, 2022

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jun 28, 2022