The STOP-MED CTRCD Trial

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorDinesh Thavendiranathan

About this trial

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.

Eligibility criteria

Qualifiers

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 <10% drop to 40-49.9% with a reduction in GLS by >15% or new abnormal Troponin I/T or NT-proBNP or SEVERE: new LVEF reduction to <40% from normal baseline LVEF), diagnosed within 1 year of completing potentially cardiotoxic cancer therapy.

Current use of ≥1 HF medication started for CTRCD for at least 6 months with LVEF ≥55% by recently performed (≤6 months) echocardiogram, normal sex and age adjusted NT-proBNP or BNP ≤97.5th Centile, and no symptoms attributable to HF.

Disqualifiers

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 will be switched to other guideline-based antihypertensive therapy).

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.

Trial design

Treatments tested in this trial

  • Stopping Heart Failure Medication(s)

Treatment groups

335 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dinesh Thavendiranathan

Lead sponsor

University Health Network, Toronto

Sponsor institution

Unity Health Toronto

Collaborator

Hamilton Health Sciences Corporation

Collaborator

St. Boniface Hospital

Collaborator

Ottawa Heart Institute Research Corporation

Collaborator

University College London Hospitals

Collaborator

Brigham and Women's Hospital

Collaborator

Baker Heart and Diabetes Institute

Collaborator

University of California, Los Angeles

Collaborator

Alberta Health services

Collaborator

Hospital Universitario La Paz

Collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

Collaborator

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborator