Instrumental and clinical effects of withdrawal of beta blockers therapy in patients with heart failure and right ventricular dysfunction'' - Destro

• Conditions: heart failure; MedDRA version: 14.1Level: LLTClassification code 10011949Term: Decompensation cardiacSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-000890-29-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-13
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <10 cm / sec or TAPS <1.6 cm and FAC <35%); c) presence of pulmonary hypertension (PAPs = 40 mmHg) 5) Taking medication ceiling optimized for the treatment of heart failure for at least 1 month, this therapy must include a beta-blocker given on a continuous basis of the following approved for the treatment of heart failure: beta-1 selective (bisoprolol, metoprolol, nebivolol), nonselective (carvedilol).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.