Heart failure
Conditions
Interventions
Trade Name: Furosemide
Product Name: furosemide
Pharmaceutical Form: Coated tablet
INN or Proposed INN: FUROSEMIDE
Other descriptive name: furosemide
Trade Name: Bisoprolol
Product Name: bisoprolol
P
Sponsors
Fundación para la formación e investigación sanitarias de la Región de Murcia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria: Patient with a CRT device for at least one year due to the presence of LBBB and LVEF 95%. NYHA functional class I-II. Absence of admissions for HF in the last year. NT-proBNP =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 <30 ml / min / 1.73m2. 7. Fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women. 8. You are currently participating in a clinical trial or have participated in the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of TF withdrawal in CRT patients with recovered LVEF, in terms of both image parameters, assessed by changes in LVEF and LV indexed end-systolic volume (VTSVIi) and clinical parameters that translate into worsening of HF. .;Secondary Objective: 1. To determine the safety of TF withdrawal in CRT patients with recovered LVEF, in terms of adverse events during follow-up (total death, cardiovascular death, hospital admission or consultation in the Emergency Department for HF and sustained supraventricular or ventricular arrhythmias) 2. The determination of changes in other echocardiographic measures as well as in the levels of natriuretic peptides, vital signs and scores in the quality of life tests. 3. The influence of cardiomyopathy genotype on the response to medication withdrawal.;Primary end point(s): Relapse of cardiomyopathy at any time in the study after withdrawal of medication, defined by at least one of the following: 1. A reduction in LVEF of more than 10% (provided that the overall LVEF is 15% in the VTSVIi compared to the previous one and in a range higher than the normal value. 3. Clinical evidence of HF 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.;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Combined total mortality, cardiovascular mortality, unplanned hospital admission or emergency room visit for HF and sustained atrial or ventricular arrhythmias (> 30 seconds). Changes with respect to baseline levels of BP and HR figures Change from baseline LVEF, left ventricular end-diastolic volume (VTDVIi), body surface indexed left atrium volume (VAIi), and changes from baseline in longitudinal global strain (GLS). Quantitative changes in NT-proBNP numbers. Changes from baseline blood pressure and heart rate figures Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) and Minnesota Living With Heart Failure (MLHFQ) scales.;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Countries
Spain
Contacts
Public ContactMaria Muñoz
Plataforma EECC IMIB
Outcome results
None listed