Older heart failure patients initiated on ivabradine in the UK: Quality of life

Not Applicable

Completed

• Conditions: Heart failure with left ventricular systolic dysfunction; Circulatory System; Heart failure

• Registration Number: ISRCTN32613680
• Lead Sponsor: Servier Laboratories Ltd (UK)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29121732

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-18
• Study Completion: 2016-11-10
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Heart failure patients:
1. Aged 70 years or older
2. Where a decision has already been made to initiate ivabradine for treatment of HF as per licensed indication for heart failure,
2.1. Chronic heart failure New York Heart Association (NYHA) Class II to IV with systolic dysfunction
2.1. In sinus rhythm with resting HR =75 beats per min
2.3. In combination with standard therapy including beta blockers or when beta blockers are contraindicated or not tolerated
3. Who have given their informed consent

Exclusion Criteria

1. Patients not receiving ivabradine as planned within 2 weeks from inclusion in the study
2. Patients no longer under the care of a study physician (named in the delegation log)
3. Patients enrolled or planning to be enrolled into an interventional clinical trial
4. Patients prescribed ivabradine in a manner not consistent with the Summary of Product Characteristics (SmPC) for congestive heart failure (CHF) with left ventricular systolic dysfunction (LVSD)
5. Patients with cognitive impairment to such a degree that the investigator feels they would be unable to complete the study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total score from the Minnesota Living with Heart Failure Questionnaire at six months. The change from baseline will be evaluated using the paired t-test.

Secondary Outcome Measures

Name	Time	Method
1. Change in 6-minute walking test data at six months is the key secondary outcome measure. The change from baseline will be evaluated using the paired t-test<br>2. The numbers of patients experiencing clinically significant changes (defined as a change of 5 units or more from baseline) in the Minnesota Living With Heart Failure Questionnaire will also be assessed