Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: (REMOVE)

Phase 1

Recruiting

Conditions: Heart Failure
MedDRA version: 20.0Level: LLTClassification code: 10019279Term: Heart failure Class: 10007541
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: CTIS2023-504946-70-00

Lead Sponsor: Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion 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.

Exclusion Criteria

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