2023-504946-70-00Active, not recruitingPhase 4
Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: (REMOVE)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Apr 2023
- Start date
- 1 Dec 2021
- Lead sponsor
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Diseases
- Heart failure
- EU CT number
- 2023-504946-70-00
- EudraCT number
- 2021-001327-41
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Lab values
- Renal failure with creatinine clearance < 30 ml/min/1.73m2.
Other
- Diabetics or hypertensives with microalbuminuria or proteinuria
- Fertile women who do not use contraception or are sterilizedsurgically; pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Badalona | Spain | Active, not recruiting |
| Hospital Universitario Severo Ochoa | Leganés | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Active, not recruiting |
| Hospital Alvaro Cunqueiro | Vigo | Spain | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.