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Behavioural Intervention

Stopping Heart Medications for Cancer Survivors (STOP-MED Trial)

Phase 4
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients (age ≥18 years) with cancer therapy completed more than 6 months prior (other than hormonal therapy) and no plan for further cancer treatments with potential risk for CTRCD
Prior cancer therapy with anthracyclines and/ or HER2-targeted therapy
Must not have
Prior history of major cardiovascular event (defined as myocardial infarction, cerebral vascular event, admission for HF) or therapeutic cardiovascular procedure (e.g., PCI, CABG)
Patients with severe CTRCD defined as having a nadir LVEF <40%1 due to the known poor prognosis in these patients2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 5 years
Awards & highlights

Summary

This trial is studying whether it is safe for cancer survivors with heart problems to stop taking their heart failure medications once their heart function has returned to normal. Currently, there is not enough scientific evidence in this

Who is the study for?
This trial is for cancer survivors who've had heart issues (CTRCD) due to cancer therapy but now have normal heart function. They should have completed their cancer treatment and be on heart medications with no other reason, like kidney disease, to keep taking them.
What is being tested?
The study tests if it's safe for these patients to stop taking their heart failure meds compared to those who continue. It involves regular check-ups and cardiac MRIs over five years to see if there's any difference in the return of heart problems between the two groups.
What are the potential side effects?
While not directly about side effects, stopping meds may lead to risks like the return of heart dysfunction. Continuing meds can cause dizziness, fatigue, financial burden, and managing long-term medication schedules.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I finished cancer treatment over 6 months ago and have no plans for more treatments that could affect my heart.
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I have previously received treatment with anthracyclines or drugs targeting HER2.
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I had a heart condition with reduced function after cancer treatment, diagnosed within the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a major heart event or heart surgery in the past.
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My heart's pumping ability is severely reduced.
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I am currently taking water pills for heart failure.
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My doctor expects I have less than a year to live or my cancer has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cancer Therapy Related Cardiac Dysfunction Relapse
Secondary study objectives
Changes in cardiac magnetic resonance parameters
Cost effectiveness analysis
Left ventricular diastolic function
+2 more
Other study objectives
Changes in quality of life score
Clinical heart failure
Impact of gender
+3 more

Side effects data

From 2022 Phase 4 trial • 58 Patients • NCT04290624
4%
Headache
4%
Burn oral cavity
4%
Lower respiratory tract infection
4%
COVID-19
4%
Hypercholesterolemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention Group
Non-intervention Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Stop GroupExperimental Treatment1 Intervention
This group will stop their heart failure medication(s) under the supervision of the study team. The investigators expect most participants in the STOP group to only be on beta-blockers and/or angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). The ACEi or ARB will be stopped first. The ACEi or ARB will be reduced by 50% every 7 days and stopped 7 days after 25% of maximal recommended dose for HF is reached. At this point (or at baseline if only on BB), the BB dose will be reduced by 50% every 7 days then stopped once 25% of the maximal dose is reached.
Group II: Standard of Care GroupActive Control1 Intervention
This group with continue with their heart failure medication(s) for at least 1 year.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
499,870 Total Patients Enrolled
Unity Health TorontoOTHER
554 Previous Clinical Trials
453,956 Total Patients Enrolled
Hamilton Health Sciences CorporationOTHER
374 Previous Clinical Trials
339,701 Total Patients Enrolled
~223 spots leftby Dec 2027
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