Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: (REMOVE)
Key facts
- Where
- Badalona, Leganés, Madrid, Majadahonda, Málaga, Murcia, Santiago de Compostela, Valencia és Vigo, SpanyolországSee the 9 sites
- Phase
- 4. fázis
Where in Spanyolország
- Hospital Universitari Germans Trias i PujolBadalona, SpanyolországNo longer taking part
- Hospital Universitario Severo OchoaLeganés, SpanyolországNo longer taking part
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországNo longer taking part
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpanyolországNo longer taking part
- Hospital Universitario Virgen de la VictoriaMálaga, SpanyolországNo longer taking part
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpanyolországNo longer taking part
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpanyolországNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországNo longer taking part
- Hospital Alvaro CunqueiroVigo, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Trial code
- EU 2023-504946-70-00
- Record updated
- 2024. május 20.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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); Currently participating in a clinical trial or have participated in the previous 30 days; 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; Renal failure with creatinine clearance < 30 ml/min/1.73m2; Diabetics or hypertensives with microalbuminuria or proteinuria; Fertile women who do not use contraception or are sterilizedsurgically; pregnant or lactating women.