Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04962711




Registration number
NCT04962711
Ethics application status
Date submitted
22/06/2021
Date registered
15/07/2021
Date last updated
28/09/2023

Titles & IDs
Public title
Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
Scientific title
Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
Secondary ID [1] 0 0
82/21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)
Other interventions - Usual care

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.

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 interventions: 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.

Other interventions: Usual care
provided by participants' usual healthcare professional(s)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in exercise capacity
Timepoint [1] 0 0
Over a period of 12 months
Secondary outcome [1] 0 0
Medication adherence
Timepoint [1] 0 0
Over a period of 12 months
Secondary outcome [2] 0 0
Neuromuscular strength
Timepoint [2] 0 0
Over a period of 12 months
Secondary outcome [3] 0 0
Endurance
Timepoint [3] 0 0
Over a period of 12 months

Eligibility
Key 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
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Screening
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
840
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04962711
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas H Marwick, MD,PhD,MPH
Address 0 0
Baker Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Joel Smith
Address 0 0
Country 0 0
Phone 0 0
+61385321962
Fax 0 0
Email 0 0
joel.smith@baker.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04962711