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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
Removal of treatment
Maintenance of pharmacological treatment
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
RECRUITING1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%
Number of patients with echocardiographic studies
Time frame: 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
Time frame: 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
Time frame: Up to 48 weeks
total mortality, (Number )
Total Number
Time frame: Up to 48 weeks
Cardiovascular mortality,
Total Number
Time frame: Up to 48 weeks
Unplanned hospital admission or emergency room visit for HF (Heart Failure)
Total Number
Time frame: Up to 48 weeks
Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).
Total Number
Time frame: Up to 48 weeks
Changes with respect to baseline levels of BP (Blood pressure )
Time frame: Up to 48 weeks
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Changes with respect to baseline levels of HR figures. (heart rate)
Time frame: Up to 48 weeks
Change from baseline LVEF
Time frame: Up to 48 weeks
Change from baseline left ventricular end-diastolic volume (VTDVIi)
Time frame: Up to 48 weeks
Change from baseline body surface indexed left atrium volume (VAIi)
Time frame: 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).
Time frame: Up to 48 weeks
Changes in the quality of life questionnaires according to The Minnesota Living with Heart Failure (MLHFQ) scales.
The response options range from 0, which indicates unaffected HRQL, to 5, which indicates the maximum impact on HRQL.
Time frame: Up to 48 weeks
Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) scales.
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.
Time frame: Up to 48 weeks