Heart failure with left ventricular systolic dysfunction Circulatory System Heart failure
Conditions
Interventions
This is an observational study so clinical care will continue as usual.
At baseline, at two months and at six months:
1. Heart rate, blood pressure and 6-minute walk test (where offered) will be reco
Sponsors
Servier Laboratories Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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 | — |
Countries
United Kingdom
Outcome results
None listed