Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy:
NCT ID: NCT05151861
Last Updated: 2021-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2021-12-03
2023-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Experimental
Complete removal of pharmacological treatment
Complete removal of pharmacological treatment
Removal of treatment
Control
Maintenance of pharmacological treatment
Control
Maintenance of pharmacological treatment
Interventions
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Complete removal of pharmacological treatment
Removal of treatment
Control
Maintenance of pharmacological treatment
Eligibility Criteria
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Inclusion Criteria
2. Current LVEF ≥50% and normal volumes in two consecutive echocardiographic studies, separated at least 3 months, and the last one performed in the previous 6 months.
3. Normally functioning CRT device with stimulation\> 95%.
4. NYHA functional class I-II.
5. Absence of admissions for HF in the last year.
6. NT-proBNP \<450pg/ml in sinus rhythm and \<900pg/ml in patients with atrial fibrillation, in the previous 6 months.
7. Pharmacological treatment with beta-blockers, ACEIs/AIIRA/RNAI with or without MRA.
8. Older than 18 years.
9. Patients who have given their informed consent in writing.
Exclusion Criteria
2. Uncontrolled arterial hypertension (figures\> 140/90 mmHg).
3. Need to use beta-blockers at the medical discretion for 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.
4. Severe valve disease.
5. Diabetic or hypertensive with microalbuminuria or proteinuria.
6. Renal failure with creatinine clearance \<30ml/min/1.73m2.
7. Fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women.
8. Patients are currently participating in a clinical trial or have participated in the past 30 days.
18 Years
ALL
No
Sponsors
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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
OTHER
Responsible Party
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Principal Investigators
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Francisco José Pastor Pérez, MD
Role: PRINCIPAL_INVESTIGATOR
HCUVA
Locations
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Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Countries
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Central Contacts
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References
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Pastor-Perez FJ, Garrido-Bravo IP, Penafiel-Verdu P, Fernandez-Villa N, Manzano-Fernandez S, Oliva-Sandoval MJ, Perez-Martinez MT, Caro-Martinez C, Hernandez-Vicente A, Pascual-Figal DA; clinical trial REMOVE researches. Withdrawal of drug therapy in responders to cardiac resynchronization therapy: rationale and design of the REMOVE trial. Rev Esp Cardiol (Engl Ed). 2024 Oct;77(10):851-858. doi: 10.1016/j.rec.2024.02.021. Epub 2024 May 1. English, Spanish.
Other Identifiers
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IMIB-RMV-2021-02
Identifier Type: -
Identifier Source: org_study_id