Clinical trial NCT05151861: Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy:
Official title: Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: Open and Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%
timeFrame: Up to 48 weeks
measure: 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
timeFrame: Up to 48 weeks
measure: 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.
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: total mortality, (Number )
timeFrame: Up to 48 weeks
measure: Cardiovascular mortality,
timeFrame: Up to 48 weeks
measure: Unplanned hospital admission or emergency room visit for HF (Heart Failure)
timeFrame: Up to 48 weeks
measure: Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).
timeFrame: Up to 48 weeks
measure: Changes with respect to baseline levels of BP (Blood pressure )
timeFrame: Up to 48 weeks
measure: Changes with respect to baseline levels of HR figures. (heart rate)
timeFrame: Up to 48 weeks
measure: Change from baseline LVEF
timeFrame: Up to 48 weeks
measure: Change from baseline left ventricular end-diastolic volume (VTDVIi)
timeFrame: Up to 48 weeks
measure: Change from baseline body surface indexed left atrium volume (VAIi)
timeFrame: Up to 48 weeks
measure: 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).
timeFrame: Up to 48 weeks
measure: Changes in the quality of life questionnaires according to The Minnesota Living with Heart Failure (MLHFQ) scales.
timeFrame: Up to 48 weeks
measure: Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) scales.
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
affiliation: HCUVA
name: Francisco José Pastor Pérez, MD
role: PRINCIPAL_INVESTIGATOR
References: