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

NCT05151861 | Unknown Phase 4

• 1 other identifier: IMIB-RMV-2021-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized trial is to investigate the effect of the complete removal of pharmacological treatment in patients responding to cardiac resynchronization therapy with recuperated LVEF in terms of imaging parameters (changes in LVEF and LV volume), as well as, clinical parameters that translate into worsening of heart failure.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• 1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%

  Number of patients with echocardiographic studies

  Up to 48 weeks

• 2. An increase >15% in the VTSVIi (The end-systolic volume of the indexed left ventricle) to the previous one and in a range higher than the normal value

  Number of patients with echocardiographic studies

  Up to 48 weeks

• 3. Clinical evidence of HF (Heart Failure) based on a global assessment, both clinical and analytical, together with the need to increase the dose of diuretics, as adjudicated by the research team.

  Number of patients with echocardiographic studies

  Up to 48 weeks

Secondary Outcomes (12)

• total mortality, (Number )

  Up to 48 weeks

• Cardiovascular mortality,

  Up to 48 weeks

• Unplanned hospital admission or emergency room visit for HF (Heart Failure)

  Up to 48 weeks

• Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).

  Up to 48 weeks

• Changes with respect to baseline levels of BP (Blood pressure )

  Up to 48 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Complete removal of pharmacological treatment

Other: Complete removal of pharmacological treatment

Control

ACTIVE COMPARATOR

Maintenance of pharmacological treatment

Drug: Control

Interventions

Complete removal of pharmacological treatment OTHER

Removal of treatment

Experimental

Control DRUG

Maintenance of pharmacological treatment

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<450pg/ml in sinus rhythm and \<900pg/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.

You may not qualify if:

• 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).
• Uncontrolled arterial hypertension (figures\> 140/90 mmHg).
• 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.
• Severe valve disease.
• Diabetic or hypertensive with microalbuminuria or proteinuria.
• Renal failure with creatinine clearance \<30ml/min/1.73m2.
• Fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women.
• Patients are currently participating in a clinical trial or have participated in the past 30 days.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Related Publications (1)

• Pastor-Perez FJ, Garrido-Bravo IP, Penafiel-Verdu P, Fernandez-Villa N, Manzano-Fernandez S, Oliva-Sandoval MJ, Perez-Martinez MT, Caro-Martinez C, Hernandez-Vicente A, Pascual-Figal DA; clinical trial REMOVE researches. Withdrawal of drug therapy in responders to cardiac resynchronization therapy: rationale and design of the REMOVE trial. Rev Esp Cardiol (Engl Ed). 2024 Oct;77(10):851-858. doi: 10.1016/j.rec.2024.02.021. Epub 2024 May 1. English, Spanish.

  PMID: 38701881 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Francisco José Pastor Pérez, MD

  HCUVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco José Pastor Pérez, MD

CONTACT

968369500; franpastor79@hotmail.com

Lola Serna Guirao

CONTACT

lola.serna@carm.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 9, 2021
• Study Start: December 3, 2021
• Primary Completion: November 15, 2022
• Study Completion: May 15, 2023
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

ES (1)