EUCTR2021-001327-41-ESActive, not recruitingPhase 1
Withdrawal of pharmacological treatment in patients responding to cardiac resynchronization therapy: Open and randomized study - Remove
Fundación para la formación e investigación sanitarias de la Región de Murcia0 sites60 target enrollmentStarted: June 11, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects must meet all of the following inclusion criteria:
- •Patient with a CRT device for at least one year due to the presence of LBBB and LVEF <40% of non-ischemic origin
- •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.
- •Normally functioning CRT device with stimulation> 95%.
- •NYHA functional class I-II.
- •Absence of admissions for HF in the last year.
- •NT-proBNP <450 pg / ml in sinus rhythm and <900 pg / ml in patients with atrial fibrillation, in the previous 6 months.
- •Pharmacological treatment with beta-blockers, ACEIs / AIIRA / RNAI with or without MRA.
- •older than 18 years.
- •Patients who have given their informed consent in writing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- •1. Previous episode of sustained ventricular tachycardia / recovered sudden death / appropriate shock (in the case of a patient with an implantable cardioverter-defibrillator associated with CRT).
- •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 <30 ml / min / 1.73m2.
- •7. Fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women.
- •8. You are currently participating in a clinical trial or have participated in the past 30 days.
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