REMOVE: Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy:
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Complete removal of pharmacological treatment |
Other: Complete removal of pharmacological treatment
Removal of treatment
|
| Active Comparator: Control Maintenance of pharmacological treatment |
Drug: Control
Maintenance of pharmacological treatment
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Secondary Outcome Measures
- total mortality, (Number ) [Up to 48 weeks]
Total Number
- 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
- Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds). [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]
- Change from baseline body surface indexed left atrium volume (VAIi) [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]
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.
Eligibility Criteria
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.
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Renal failure with creatinine clearance <30ml/min/1.73m2.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clínico Universitario Virgen de la Arrixaca | Murcia | Spain | 30120 |
Sponsors and Collaborators
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Investigators
- Principal Investigator: Francisco José Pastor Pérez, MD, HCUVA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMIB-RMV-2021-02