Will it be better to use Beta Blocker and Procoralan when suffering of chronical heart failure, in order to reduce heart frequence at rest?

• Conditions: Patients with chronic heart failure and resting heart rate of = 75 bmp; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-000269-27-DE
• Lead Sponsor: German Foundation for Chronically Ill

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-23
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

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

Inclusion Criteria

•Symptomatic heart failure with reduced left ventricular function caused by dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICMP)
•Heart rate = 75 bpm
•NYHA Class II-IV
•Sinus rhythm
•Cognitive capacity
•Age = 18 years
•Stable HF medication including beta-blocker
•Dose of beta-blocker = 50% of advised dose according to German product information or beta-blocker naive patient
•Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Pregnancy
•Systolic blood pressure < 95 mm Hg
Cardiac decompensation within the last 8 weeks prior to recruitment
•Significantly reduced renal function (GFR < 30)
•Planned invasive medical intervention within the next 8 weeks
•Lack of communication skills
•Permanent atrial fibrillation and/or paroxysmal AF documented in two ECGs
•Implanted active CRT-Device or active pacemaker
•Patients with a contraindication for beta-blocker therapy
•Patients under current Ivabradine-therapy
•Patients paticipats in a competing clinical trial (identical/overlapping) inclusion criteria
•Patients living in a geographic region without sufficient cell network coverage

Study & Design

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