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Withdrawal of neurohormonal therapy in patients with non-ischemic cardiomyopathy, no late gadolinium enhancement, and negative genetic testing, who have exhibited super-response to cardiac resynchronization therapy. DRUGLESS-CRT clinical trial.
EU CTIS ID: 2025-521780-12-00
What this study is testing
Demonstrate that the withdrawal of neurohormonal treatment is not inferior to its maintenance in terms of recurrence of left ventricular dysfunction or heart failure symptoms, in patients with non-ischemic cardiomyopathy, without significant arrhythmia, with negative genetic testing who have been super-responders to cardiac resynchronization therapy
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age >18 years
- NYHA Class I or II
- NT-proBNP <450 ng/L (or <1000 ng/L if atrial fibrillation or atrial flutter)
- Neurohormonal treatment with at least two medications
- Diagnosis of non-ischemic cardiomyopathy
- Negative genetic test (at least 50 genes evaluated)
You likely can't join if
- Severe valvulopathy
- History of sustained ventricular arrhythmia or treated by ICD
- Need to maintain beta-blocker therapy for other arrhythmias
- Hypertension that cannot be controlled with other medications
- Resynchronization devices implanted as an upgrade from previous pacemaker or ICD, where the pacing percentage before the upgrade was >20%.
See the full eligibility criteria
- Age >18 years
- NYHA Class I or II
- NT-proBNP <450 ng/L (or <1000 ng/L if atrial fibrillation or atrial flutter)
- Neurohormonal treatment with at least two medications
- Diagnosis of non-ischemic cardiomyopathy
- Negative genetic test (at least 50 genes evaluated)
- Cardiac magnetic resonance imaging without evidence of late gadolinium enhancement (RTG is accepted at the insertion points of the right ventricle).
- Carrier of a resynchronization device (ICD or pacemaker, biventricular stimulation or left branch area stimulation) with >95% pacing and stimulated QRS <140ms.
- Indication for resynchronization device: LVEF ≤35% and LBBB with QRS >150ms
- LVEF ≥50% and normal indexed left ventricular volumes on echocardiogram performed at least 6 months after the resynchronization device implantation.
- No heart failure decompensations (no hospital admissions, no emergency visits, or day care hospital visits) since the implantation of the resynchronization device.
- No need for loop diuretic treatment.
- Severe valvulopathy
- History of sustained ventricular arrhythmia or treated by ICD
- Need to maintain beta-blocker therapy for other arrhythmias
- Hypertension that cannot be controlled with other medications
- Resynchronization devices implanted as an upgrade from previous pacemaker or ICD, where the pacing percentage before the upgrade was >20%.
The study team makes the final eligibility decision.
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.