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Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: (REMOVE)
EU CTIS ID: 2023-504946-70-00
What this study is testing
To determine the effect of withdrawing pharmacologic treatment in patients with cardiac resynchronization therapy with recovered LVEF, in terms of both imaging parameters (changes in LVEF and LV volume) as well as clinical parameters that reflect worsening of the heart failure.
- Therapeutic use (Phase IV)
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
- Patients who have received cardiac resynchronization therapy at least one year before for left bundle branch block and LVEF <40% of non-ischemic origin.
- Current LVEF ≥ 50% and normal volumes in two studies consecutive echocardiograms, separated by at least 3 months, with the last performed in the previous six months.
- NYHA functional class I-II
- Absence of admissions for heart failure in the last year
- NT-proBNP <450 pg/mL in patients in sinus rhythm or <900 pg/mL in patients with atrial fibrillation, in the previous 6 months.
- Pharmacological treatment with beta-blockers, ACEIs/ARA II/ARNI with or without ARM
You likely can't join if
- Previous episode of sustained ventricular tachycardia/sudden death recovered/appropriate discharge (in case of being a carrier of implantable cardioverter-defibrillator associated with cardiac resynchronization therapy)
- Uncontrolled arterial hypertension (figures >140/90 mmHg).
- Need for the use of beta-blockers at the medical discretion of other indications such as heart rate (HR) control in atrial fibrillation (in the absence of ablation of the atrioventricular node) or to control other supra or ventricular arrhythmias.
- Severe valve disease.
- Diabetics or hypertensives with microalbuminuria or proteinuria
- Renal failure with creatinine clearance < 30 ml/min/1.73m2.
See the full eligibility criteria
- Patients who have received cardiac resynchronization therapy at least one year before for left bundle branch block and LVEF <40% of non-ischemic origin.
- Current LVEF ≥ 50% and normal volumes in two studies consecutive echocardiograms, separated by at least 3 months, with the last performed in the previous six months.
- NYHA functional class I-II
- Absence of admissions for heart failure in the last year
- NT-proBNP <450 pg/mL in patients in sinus rhythm or <900 pg/mL in patients with atrial fibrillation, in the previous 6 months.
- Pharmacological treatment with beta-blockers, ACEIs/ARA II/ARNI with or without ARM
- Normally functioning cardiac resynchronization therapy device with >95% pacing
- Older than 18 years
- Patients who have given their written informed consent.
- Previous episode of sustained ventricular tachycardia/sudden death recovered/appropriate discharge (in case of being a carrier of implantable cardioverter-defibrillator associated with cardiac resynchronization therapy)
- Uncontrolled arterial hypertension (figures >140/90 mmHg).
- Need for the use of beta-blockers at the medical discretion of other indications such as heart rate (HR) control in atrial fibrillation (in the absence of ablation of the atrioventricular node) or to control other supra or ventricular arrhythmias.
- Severe valve disease.
- Diabetics or hypertensives with microalbuminuria or proteinuria
- Renal failure with creatinine clearance < 30 ml/min/1.73m2.
- Fertile women who do not use contraception or are sterilizedsurgically; pregnant or lactating women.
- Currently participating in a clinical trial or have participated in the previous 30 days
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
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.