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

Phase 4

• Conditions: Heart Failure
• Interventions: Other: Complete removal of pharmacological treatment; Drug: Control

• Registration Number: NCT05151861
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-26
• Status Verified: 2021-12
• Study Start: 2021-12-03
• Study First Posted: 2021-12-09
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-30
• Primary Completion: 2022-11-15
• Study Completion: 2023-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patient with a CRT device for at least one year due to the presence of LBBB and LVEF <40% of non-ischemic origin
2. 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.
3. Normally functioning CRT device with stimulation> 95%.
4. NYHA functional class I-II.
5. Absence of admissions for HF in the last year.
6. NT-proBNP <450pg/ml in sinus rhythm and <900pg/ml in patients with atrial fibrillation, in the previous 6 months.
7. Pharmacological treatment with beta-blockers, ACEIs/AIIRA/RNAI with or without MRA.
8. Older than 18 years.
9. Patients who have given their informed consent in writing.

Exclusion Criteria

1. 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).
2. Uncontrolled arterial hypertension (figures> 140/90 mmHg).
3. 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.
4. Severe valve disease.
5. Diabetic or hypertensive with microalbuminuria or proteinuria.
6. Renal failure with creatinine clearance <30ml/min/1.73m2.
7. Fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women.
8. Patients are currently participating in a clinical trial or have participated in the past 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Complete removal of pharmacological treatment	Complete removal of pharmacological treatment
Control	Control	Maintenance of pharmacological treatment

Primary Outcome Measures

Name	Time	Method
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.	Up to 48 weeks	Number of patients with echocardiographic studies
1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%	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	Up to 48 weeks	Number of patients with echocardiographic studies

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality,	Up to 48 weeks	Total Number
Unplanned hospital admission or emergency room visit for HF (Heart Failure)	Up to 48 weeks	Total Number
total mortality, (Number )	Up to 48 weeks	Total Number
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	Total Number
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	The response options range from 0, which indicates unaffected HRQL, to 5, which indicates the maximum impact on HRQL.
Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) scales.	Up to 48 weeks	The KCCQ is a 23-item (15 question) self-administered questionnaire designed to quantify physical limitations, symptoms (frequency, severity and recent change over time), social limitations, self-efficacy, and quality of life.As described, all KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Change from baseline body surface indexed left atrium volume (VAIi)	Up to 48 weeks

Trial Locations

Locations (1)

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain