heart failure MedDRA version: 14.1 Level: LLT Classification code 10011949 Term: Decompensation cardiac System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Carvedilol
Concentration unit: mg milligram(s)
Concentration number: 25-
Pharmaceutical Form: Tablet
INN or Proposed INN: Nebivolol
Concentration unit
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) age = 18 years, of both sexes 2) Presence of symptoms of congestive heart failure in particular belonging to NYHA II B class or higher 3) Presence of one or more signs of congestive heart failure: fluid retention (edema slopes, swelling of the jugular veins, ascites, anasarca), signs of reduced cardiac output (reduced functional capacity, fatigue) and, but not necessarily signs of pulmonary congestion (dyspnea, rales auscultation, pulmonary edema) 4) Presence of all of the following echocardiographic criteria: a) obvious left ventricular systolic dysfunction: EF = 45%, b) clear right ventricular systolic dysfunction (TDI S =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pulmonary embolism occurred in the 3 months period prior to enrollment 2) System of AICD-CRT made for less than 6 months from the date of enrollment 3)unstable angina or acute coronary syndrome in the month period prior to enrollment 4) hemodynamically significant arrhythmia (ventricular tachycardia, atrial fibrillation / atrial flutter with high ventricular response [> 130 bpm], atrioventricular block second degree Mobitz II or 3rd degree atrioventricular block, bradyarrhythmias [<45 bpm]) 5) severe renal insufficiency (GFR <15 mL/min/1.73 m2) 6) neoplasm in a non remission phase 7) Severe comorbidity so that they are expected to live less than one year 8) Taking beta-blocker therapy for prophylaxis of bleeding from esophageal varices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall Objective: Assess the effects of beta-blocker discontinuation of therapy in patients with biventricular heart failure and persistence of symptoms of heart failure. Main Objective: exercise tolerance;Secondary Objective: Secondary objective: effects on symptoms and signs of heart failure; effects on bi ventricular function and pulmonary pressure; rehospitalization for heart failure; cardiac mortality.;Primary end point(s): The primary outcome of the study is the exercise tolerance as measured by VO2 measured at 6 months. | — |
Countries
Italy
Outcome results
None listed