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

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR0 sitesMarch 13, 2012

Overview

No summary available.

Registry

who.int

Start Date

March 13, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

•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

•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