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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

Next steps

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (9)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Germans Trias i PujolBadalonaSpainActive, not recruiting
Hospital Universitario Severo OchoaLeganésSpainActive, not recruiting
Hospital Universitario Fundación Jiménez DíazMadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de MajadahondaMajadahondaSpainActive, not recruiting
Hospital Universitario Virgen de la VictoriaMálagaSpainActive, not recruiting
University Clinical Hospital Virgen De La ArrixacaMurciaSpainActive, not recruiting
Complexo Hospitalario Universitario De SantiagoSantiago de CompostelaSpainActive, not recruiting
Hospital Universitario Y Politecnico La FeValenciaSpainActive, not recruiting
Hospital Alvaro CunqueiroVigoSpainActive, not recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.