Clinical trial for Heart Failure
Official title The STOP-MED CTRCD Trial
ClinicalTrials.gov ID: NCT06183437
What this study is testing
- What it's testing
- The study wants to find out whether stopping heart failure medication is as safe as continuing it for patients whose heart function has returned to normal after cancer treatment.
- Who it's for
- Adults who have finished cancer therapy, have had heart problems from the treatment, and now have normal heart function.
- What's involved
- Participants will be randomly assigned to keep taking their heart medicines or to stop them, and will have heart scans (MRI) and safety check‑ups at several time points.
- Time commitment
- The trial lasts up to 5 years with visits at about 6‑8 weeks, 6 months, 1 year, 3 years and 5 years, plus MRI scans at baseline, 1 year and 5 years.
- Phase 4: studies an already-approved treatment
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (age ≥18 years) with cancer therapy completed more than 6 months prior (other than hormonal therapy) and no plan for further cancer...
- Prior cancer therapy with anthracyclines and/ or HER2-targeted therapy.
- Prior asymptomatic, moderate to severe CTRCD, defined using the ESC/ICOS criteria (MODERATE: ≥10% drop in LVEF from baseline to 40% to 49.9% OR \ 15%...
- Current use of ≥1 HF medication started for CTRCD for at least 6 months with LVEF ≥50% by recently performed (≤6 months) echocardiogram, normal sex...
- Reference ranges for NT-proBNP and BNP by age and sex: \<30 years: Female: NT-proBNP ≤196 pg/ml, BNP ≤55 pg/ml Male: NT-proBNP ≤104 pg/ml, BNP ≤29...
You likely can't join if
- Indication for continuation of HF medications i.e., ongoing HF symptoms, chronic kidney disease (CKD), vascular disease, atrial or ventricular...
- Contraindications for CMR (e.g., MRI non-compatible implanted pacemakers).
- Patients with cardiac devices i.e. defibrillator, CRT, pacemaker, etc.
- Continued use of loop diuretic therapy for heart failure purposes i.e., furosemide.
- Life expectancy \<1 year or metastatic disease.
- Prior history of major cardiovascular event (defined as myocardial infarction, cerebral vascular event, admission for HF) or therapeutic...
See the full eligibility criteria
- 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.
- Prior asymptomatic, moderate to severe CTRCD, defined using the ESC/ICOS criteria (MODERATE: ≥10% drop in LVEF from baseline to 40% to 49.9% OR \ 15% or new abnormal Troponin I/T or NT-proBNP or SEVERE: new LVEF...
- Current use of ≥1 HF medication started for CTRCD for at least 6 months with LVEF ≥50% by recently performed (≤6 months) echocardiogram, normal sex and age adjusted NT-proBNP or BNP ≤97.5th Centile, and no symptoms...
- Reference ranges for NT-proBNP and BNP by age and sex: \<30 years: Female: NT-proBNP ≤196 pg/ml, BNP ≤55 pg/ml Male: NT-proBNP ≤104 pg/ml, BNP ≤29 pg/ml 30-39 years: Female: NT-proBNP ≤209 pg/ml, BNP ≤59 pg/ml Male...
- Confirmation of LVEF ≥50% and normal volumes at baseline CMR (i.e., some patients recruited based on echocardiography, may be excluded if baseline CMR LVEF/volumes are not normal).
- Normal Ventricular end-diastolic volumes by CMR as defined by the Society of Cardiac Magnetic Resonance 2025 update.
- Indication for continuation of HF medications i.e., ongoing HF symptoms, chronic kidney disease (CKD), vascular disease, atrial or ventricular arrythmias, other (note: participants with hypertension pre-CTRCD will...
- Contraindications for CMR (e.g., MRI non-compatible implanted pacemakers).
- Patients with cardiac devices i.e. defibrillator, CRT, pacemaker, etc.
- Continued use of loop diuretic therapy for heart failure purposes i.e., furosemide.
- Life expectancy \<1 year or metastatic disease.
- Prior history of major cardiovascular event (defined as myocardial infarction, cerebral vascular event, admission for HF) or therapeutic cardiovascular procedure (e.g., percutaneous coronary intervention (PCI), coronary...
- Issues that prevent communication, understanding or presentation for study-related visits and inability to provide informed consent.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
- Melbourne, Victoria, Australia
- Edmonton, Alberta, Canada
- Winnipeg, Manitoba, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- London, London, United Kingdom
- Liverpool, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States; Melbourne, Victoria, Australia; Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.