Older heart failure patients initiated on ivabradine in the UK: Quality of life
| ISRCTN | ISRCTN32613680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32613680 |
| Secondary identifying numbers | IC416257001GBR |
- Submission date
- 07/11/2013
- Registration date
- 18/11/2013
- Last edited
- 06/09/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
1-2% of the UK population have heart failure, which accounts for around 900,000 people in the UK. The main aims of heart failure treatment include reducing symptoms, improving levels of activity, reducing the number of hospital visits and improving how patients feel (quality of life). This study is focused on a group of older people in the UK who have recently been started on a treatment with a drug called ivabradine for heart failure. This study aims to examine their quality of life over a period of time after starting the treatment.
Who can participate?
People aged at least 70 years, who have heart failure and who have been started on ivabradine medication for their heart failure by their doctor can participate in this study.
What does the study involve?
Patients will see their doctor as usual and complete two short questionnaires to assess their quality of life. Their doctor will record their heart rate and blood pressure, and conduct a walking test where applicable, on entry to the study, after two months and then again after four months. These tests and questions are carried out as part of normal care. Patients will be followed up for around 6 months.
What are the possible benefits and risks of participating?
There are no direct benefits expected from being involved in the research, although the results could be used to improve patient care in future. There are no additional risks of participating as usual clinical care continues throughout the study. The risks of personal data being disclosed are slight as only encrypted anonymised data will leave NHS premises.
Where is the study run from?
The study is run from about 50 UK sites (including general practices and hospital outpatient departments).
When is study starting and how long is it expected to run for?
The study will start in January 2014 and is expected to run until August 2014.
Who is funding the study?
Servier Laboratories Ltd (UK)
Who is the main contact?
Medical Information - Servier
01753 666409
medical.information@uk.netgrs.com
Contact information
Scientific
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Study information
| Study design | Multicentre longitudinal observational single-cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | LIVE:LIFE - OLder heart failure patients Initiated on iVabradinE in UK quaLIty of liFE |
| Study acronym | LIVE:LIFE |
| Study objectives | The hypothesis is that we will see an improvement in the quality of life, i.e. a greater than 20% reduction of the baseline Minnesota Living With Heart Failure Scores (lower scores meaning a better quality of life). |
| Ethics approval(s) | NRES North East Newcastle and North Tyneside 2, 13/11/2013, ref: 13/NE/0345 |
| Health condition(s) or problem(s) studied | Heart failure with left ventricular systolic dysfunction |
| Intervention | 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 recorded 2. Responses to the Minnesota Living With Heart Failure Questionnaire and SF12 questionaire will be used to formally assess quality of life After a further 12 months (i.e. at 18 months from baseline) data about patients' medications (i.e. doses and total number) will be collected from their medical records. |
| Intervention type | Other |
| Primary outcome measure | 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 | 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 |
| Overall study start date | 01/01/2014 |
| Completion date | 10/11/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 220 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 31/03/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
Industry
Sefton House
Sefton Park
Bells Hill
Stoke Poges
SL2 4JS
United Kingdom
| Website | http://www.servier.co.uk/ |
|---|---|
"ROR" |
https://ror.org/02fbwdh31 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/10/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication planned in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. Requests should be made through the following website for the attention of the Medical Affairs Department (General enquiry): https://servier.co.uk/content/contact-us. As specified in the Study Protocol, anonymised patient-level data will be made available to the research community on reasonable request until November 2023, as a Microsoft Excel spreadsheet. Access to the study data will be at Servier’s discretion as study Sponsors. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/12/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/09/2018: IPD sharing statement added.
06/08/2018: Publication reference added, sponsor address updated.
09/02/2017: Internal Review.
02/02/2017: Overall trial dates were updated from 01/01/2014 - 01/08/2014 to 01/01/2014 - 10/11/2016. Recruitment dates were changed from 01/01/2014 - 01/08/2014 to 01/01/2014 - 31/03/2015. Sample size changed from 500 to 220.
20/01/2017: No publications found in PubMed, verifying study status with principal investigator.
