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

Primary Purpose

Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)

Usual care

About this trial

This is an interventional screening trial for Heart Failure

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Baker Heart and Diabetes InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in exercise capacity

Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.

Secondary Outcome Measures

Medication adherence

proportion of ACEi and beta blocker tablets taken

Neuromuscular strength

Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer

Endurance

Increase in total exercise duration.

Full Information

NCT ID

NCT04962711

First Posted

June 22, 2021

Last Updated

September 26, 2023

Sponsor

Baker Heart and Diabetes Institute

1. Study Identification

Unique Protocol Identification Number

NCT04962711

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baker Heart and Diabetes Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomization to CO-DMP or usual care

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

Usual care

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)

Intervention Description

A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.

Intervention Type

Other

Intervention Name(s)

Usual care

Intervention Description

provided by participants' usual healthcare professional(s)

Primary Outcome Measure Information:

Title

Change in exercise capacity

Description

Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.

Time Frame

Over a period of 12 months

Secondary Outcome Measure Information:

Title

Medication adherence

Description

proportion of ACEi and beta blocker tablets taken

Time Frame

Over a period of 12 months

Title

Neuromuscular strength

Description

Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer

Time Frame

Over a period of 12 months

Title

Endurance

Description

Increase in total exercise duration.

Time Frame

Over a period of 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joel Smith

Phone

+61385321962

joel.smith@baker.edu.au

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas H Marwick, MD,PhD,MPH

Phone

+61385321550

tom.marwick@baker.edu.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas H Marwick, MD,PhD,MPH

Organizational Affiliation

Baker Heart and Diabetes Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baker Heart and Diabetes Institute

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Marwick

Phone

+61385321550

tom.marwick@baker.edu.au

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data sharing based available on application to the study PI

Learn more about this trial

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

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