Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06183437

The STOP-MED CTRCD Trial

Led by Dinesh Thavendiranathan · Updated on 2026-03-30

335

Participants Needed

14

Research Sites

404 weeks

Total Duration

On this page

Sponsors

D

Dinesh Thavendiranathan

Lead Sponsor

U

Unity Health Toronto

Collaborating Sponsor

AI-Summary

What this Trial Is About

Cancer therapy-related cardiac dysfunction (CTRCD) is when the heart's ability to pump oxygenated blood to the body is compromised. It is a side effect of cancer therapy which can occur as commonly as in 1 in 5 patients. When this occurs, heart failure medications are started to protect the heart from progressing to heart failure. With early detection and treatment, heart function recovers to normal in \>80% of patients. Unfortunately, heart failure medications are associated with an undesirable long-term pill burden, financial costs, and side-effects (e.g., dizziness and fatigue). As a result, cancer survivors frequently ask if they can safely stop their heart failure medications once their heart function has returned to normal. Currently there is no scientific evidence in this area of Cardio-Oncology. To address this knowledge gap, the investigators have designed a randomized control trial to assess the safety of stopping heart failure medication in patients with CTRCD and recovered heart function. The investigators will enrol patients who have completed their cancer therapy and are on heart medications for their CTRCD, which has now normalized. The investigators will randomize patients with no other reasons to continue heart failure medications (e.g., kidney disease) to continuing or stopping their heart medications safely. All patients will undergo a cardiac MRI at baseline, 1 and 5 years with safety assessments at 6-8 weeks, 6 months and 3 and 5 years. The investigators will determine if stopping medications is non-inferior to continuing medications by counting the numbers of patients who develop heart dysfunction by 1 year in each group.

CONDITIONS

Official Title

The STOP-MED CTRCD Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 years or older
  • Completed cancer therapy more than 6 months ago, excluding hormonal therapy, with no planned further cancer treatments that could cause CTRCD
  • Prior treatment with anthracyclines and/or HER2-targeted therapy
  • History of moderate to severe asymptomatic CTRCD diagnosed within 1 year after cancer therapy
  • Currently using at least one heart failure medication for CTRCD for at least 6 months
  • Normal heart function with left ventricular ejection fraction (LVEF) of 55% or higher confirmed by recent echocardiogram and cardiac MRI
  • Normal age- and sex-adjusted NT-proBNP or BNP levels
Not Eligible

You will not qualify if you...

  • Need to continue heart failure medications due to ongoing symptoms, chronic kidney disease, vascular disease, or heart rhythm problems
  • Contraindications to cardiac MRI, such as having non-compatible implanted pacemakers
  • Presence of cardiac devices like defibrillators, CRT, or pacemakers
  • Current use of loop diuretics for heart failure
  • Life expectancy less than 1 year or presence of metastatic cancer
  • History of major cardiovascular events like heart attack, stroke, heart failure hospitalization, or heart procedures
  • Conditions preventing study communication, understanding, or consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

University of California, Los Angeles

Los Angeles, California, United States, 90095

Not Yet Recruiting

2

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

3

Baker Heart and Diabetes Institute

Melbourne, Victoria, Australia, 3004

Actively Recruiting

4

Cardio-Oncology Clinic, MAHI, University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 1C9

Not Yet Recruiting

5

St. Boniface Hospital

Winnipeg, Manitoba, Canada, R2H 2A6

Actively Recruiting

6

Hamilton General Hospital

Hamilton, Ontario, Canada, L8L 2X2

Not Yet Recruiting

7

University of Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7

Actively Recruiting

8

St Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Not Yet Recruiting

9

University Health Network

Toronto, Ontario, Canada, M5G2C4

Actively Recruiting

10

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Not Yet Recruiting

11

La Paz University Hospital

Madrid, Spain, 28046

Not Yet Recruiting

12

Barts Health NHS Trust, University College London

London, London, United Kingdom

Actively Recruiting

13

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom, L14 3PE

Not Yet Recruiting

14

Guy's and St Thomas' NHS Foundation Trust (Royal Brompton Hospital)

London, United Kingdom

Not Yet Recruiting

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Research Team

P

Paaladinesh Thavendiranathan, MD

CONTACT

S

Sadia Khan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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