Comparison of Bisoprolol and Carvedilol in elderly heart failure (HF) patients: a randomised, double-blind multicentre study

Not Applicable

Completed

• Conditions: Chronic heart failure; Circulatory System; Heart failure

• Registration Number: ISRCTN34827306
• Lead Sponsor: German Heart Failure Competence Network (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-07
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1040

Inclusion Criteria

Current inclusion criteria as of 15/01/2008:
1. Age greater than or equal to 65 years
2. Current diagnosis of chronic heart failure from New York Heart Association (NYHA) II - IV or ejection fraction (EF) less than 40%
3. Clinically stable heart failure for 2 weeks before inclusion
4. Informed consent

Previous inclusion criteria:
1. Age greater than or equal to 65 years
2. Chronic heart failure New York Heart Association (NYHA) II - IV or ejection fraction (EF) less than 40%
3. Clinically stable heart failure for 2 weeks before inclusion
4. Informed consent given

Exclusion Criteria

Current exclusion criteria as of 15/01/2008:
Most relevant exclusion criteria:
1. Acute/decompensated HF
2. Shock, pulmonary embolism
3. Obstructive/restrictive cardiomyopathy
4. Severe pulmonary disorders/asthma
5. Inflammatory heart diseases
6. Standard exclusion criteria (as listed in the protocol)
7. Contraindications against beta blockers (as listed in the protocol)
8. Restricted concomittant medication (as listed in the protocol)

Previous exclusion criteria:
Most relevant exclusion criteria:
1. Acute/decompensated HF
2. Shock, pulmonary embolism
3. Obstructive/restrictive cardiomyopathy
4. Severe pulmonary disorders/asthma
5. HTN not controlled
6. Inflammatory heart diseases
7. Standard exclusion criteria (as listed in the protocol)
8. Contraindications against beta blockers (as listed in the protocol)
9. Restricted concomittant medication (as listed in the protocol)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 15/01/2008:<br>Tolerance (yes/no) of the study medication target dose as per cardiology guidelines. Tolerance (= yes) is defined when:<br>1. Dose titration was possible up to the target dose<br>2. The study medication dose was not reduced. It is irrelevant whether unscheduled T-visits took place if the titration aim was not affected<br>3. The target dose is to be taken at the time of last visit. This dose has remained stable for at least 10 days. Tolerance is ascertained (i.e. there is no reason for dose reduction and the patient did not reduce it independently either)<br><br>Previous primary outcome measures:<br>Tolerability, measured as individually achieved dose at end of titration.