Condition category
Circulatory System
Date applied
07/11/2013
Date assigned
18/11/2013
Last edited
18/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
The study is funded by Servier Laboratories Ltd (UK).

Who is the main contact?
Medical Information - Servier
01753 666409
medical.information@uk.netgrs.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Kalra

ORCID ID

Contact details

Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC416257001GBR

Study information

Scientific title

LIVE:LIFE - OLder heart failure patients Initiated on iVabradinE in UK quaLIty of liFE

Acronym

LIVE:LIFE

Study hypothesis

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

Submitted to UK NRES: North East – Newcastle and North Tyneside 2, Reference 13/NE/0345

Study design

Multicentre longitudinal observational single-cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2014

Overall trial end date

01/08/2014

Reason abandoned

Eligibility

Participant 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, i.e.:
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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

500

Participant 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

Recruitment start date

01/01/2014

Recruitment end date

01/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Alexandra Hospital
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

Servier Laboratories Ltd (UK)

Sponsor details

Rowley
Wexham Springs
Framewood Road
Wexham
Berkshire
Slough
SL3 6PJ
United Kingdom

Sponsor type

Industry

Website

http://www.servier.co.uk/

Funders

Funder type

Industry

Funder name

Servier Laboratories Ltd. (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes