Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: Open and Randomized Study

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia1 site in 1 country60 target enrollmentDecember 3, 2021

ConditionsHeart Failure

InterventionsComplete removal of pharmacological treatment Control

Overview

Phase: Phase 4
Intervention: Complete removal of pharmacological treatment
Conditions: Heart Failure
Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Enrollment: 60
Locations: 1
Primary Endpoint: 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.
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 3, 2021

End Date

May 15, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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/1.73m
•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.

Arms & Interventions

Experimental

Complete removal of pharmacological treatment

Intervention: Complete removal of pharmacological treatment

Control

Maintenance of pharmacological treatment

Intervention: Control

Outcomes

Primary Outcomes

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.

Time Frame: Up to 48 weeks

Number of patients with echocardiographic studies

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

Time Frame: Up to 48 weeks

Number of patients with echocardiographic studies

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

Time Frame: Up to 48 weeks

Number of patients with echocardiographic studies

Secondary Outcomes

Cardiovascular mortality,(Up to 48 weeks)
Unplanned hospital admission or emergency room visit for HF (Heart Failure)(Up to 48 weeks)
total mortality, (Number )(Up to 48 weeks)
Changes with respect to baseline levels of BP (Blood pressure )(Up to 48 weeks)
Changes with respect to baseline levels of HR figures. (heart rate)(Up to 48 weeks)
Change from baseline LVEF(Up to 48 weeks)
Change from baseline left ventricular end-diastolic volume (VTDVIi)(Up to 48 weeks)
Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).(Up to 48 weeks)
Changes from baseline in global longitudinal strain (GLS).GLS is a simple parameter that expresses longitudinal shortening as a percentage (change in length as a proportion to baseline length).(Up to 48 weeks)
Changes in the quality of life questionnaires according to The Minnesota Living with Heart Failure (MLHFQ) scales.(Up to 48 weeks)
Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) scales.(Up to 48 weeks)
Change from baseline body surface indexed left atrium volume (VAIi)(Up to 48 weeks)