Plain English Summary
Background and study aims
Heart failure (HF) is associated with a high mortality and morbidity, reduced quality of life, and increasing health care costs in Europe as well as across the world. The prescription of evidence-based therapies recommended by guidelines is the most effective way of ensuring that patients receive high-quality and optimal care. Surveys of patients with HF often provide descriptions of the clinical characteristics and management of patients and of outcomes, but we lack data on the use of guideline-recommended therapies in all potentially eligible patients. This is the aim of this study.
Who can participate?
Adult outpatients with chronic HF and left ventricular systolic dysfunction (LVSD).
What does the study involve?
Physician selection is based on the best available sources, either local or regional, concerning the epidemiology and medical care data, including available market data and epidemiological surveys. A general target of 10-20 consecutive patients per investigator was used ensuring the best possible representative inclusion of the HF population in each practice setting.
Information collected includes: demographics; medical history; risk factors and lifestyle; results of physical examination; current symptoms; laboratory values if available; and current medical treatments. Adherence to evidence-based pharmacologic treatments recommended by guidelines will be determined by calculating the adherence score, taking into account the treatment eligibility criteria and the existence of contraindications to drugs based on the international guidelines on management of HF.
What are the possible benefits and risks of participating?
This information is expected to be important to physicians, care providers, and health services, by identifying gaps between evidence and practice and areas for improvement in the post-discharge care of outpatients with chronic HF and LVSD. Physicians have been instructed to continue management and treatment of patients according to their usual practice and the new international guidelines for the management of HF. No specific tests or therapies will be prescribed as part of this survey, and the management of patients will be completely left to the discretion of participating physicians.
Where is the study run from?
547 centres from 36 countries
When is the study starting and how long is it expected to run for?
January 2013 to September 2018
Who is funding the study?
Servier (France)
Who is the main contact?
Professor Michel Komajda
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
QUAlity of adherence to guideline recommendations for LIfe-saving treatment in heart failure: an international surveY: an observational study
Acronym
QUALIfY
Study hypothesis
1. Assess clinical characteristics and management of outpatients with heart failure
2. Focus on how monitoring of disease status can be used to guide treatment
3. Evaluate the prescription of recommended therapeutic options in eligible patients
4. Assess adherence to the new European Society of Cardiology guidelines for the management of heart failure
Ethics approval(s)
Ethics approval obtained in every country in accordance with local regulations. All 557 centres obtained ethics approval before recruitment of the first participant (the first approval was obtained on 10/06/2013 from the Ethics Committee at the National Institute of Cardiovascular Diseases, Slovakia; approval for the last site was on 20/09/2014 from McGill University Health Centre Biomedical D, Canada).
Study design
Prospective observational longitudinal survey
Primary study design
Observational
Secondary study design
Longitudinal study
Study setting(s)
Other
Study type
Other
Patient information sheet
Condition
Heart failure
Intervention
Non-interventional survey
Intervention type
Other
Primary outcome measure
1 To evaluate physician’s adherence to HF guidelines by measuring prescriptions modalities of recommended HF medications
2. To calculate an adherence score
3. To analyze the reasons for non-adherence
4. To assess the impact of adherence level on clinical outcomes
Measured at baseline and at 6, 12 and 18 months.
Secondary outcome measures
To characterize the clinical characteristics and management of outpatients with HF and left ventricular systolic dysfunction (LVSD).
Measured at baseline and at 6, 12 and 18 months.
Overall study start date
01/01/2013
Overall study end date
01/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Outpatients with chronic heart failure:
1. > 18 years of age
2. Hospitalised for worsening of heart failure within 1–15 months
3. With LVSD as demonstrated by left ventricular ejection fraction ≤ 40% measured using the most recent echocardiogram (≤ 2 years)
4. Validation of rhythm at inclusion
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
7092
Participant exclusion criteria
1. Patients on waiting list for heart transplantation or planned implantation of left ventricular assist device; planned cardiac resynchronisation therapy and implantable cardioverter defibrillators are permitted
2. Patients with planned revascularisation
3. Patients hospitalised for cardiovascular disease within the past 4 weeks
4. Conditions hampering participation or the 18-month follow-up
Recruitment start date
01/09/2013
Recruitment end date
30/12/2014
Locations
Countries of recruitment
Armenia, Australia, Austria, Azerbaijan, Bahrain, Belarus, Brunei, Canada, China, Denmark, Egypt, Georgia, Germany, Greece, Hungary, Ireland, Jordan, Kazakhstan, Korea, South, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Oman, Poland, Portugal, Qatar, Romania, Russian Federation, Slovakia, Spain, Thailand, Turkey, Ukraine, United Arab Emirates
Study participating centre
547 from 36 countries
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France
Sponsor information
Organisation
Servier
Sponsor details
35 rue de Verdun
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/12/2016
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Other
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2016 | Yes | No | |
| Results article | 10/02/2021 | 14/06/2023 | Yes | No | |
| Results article | 30/04/2017 | 14/06/2023 | Yes | No |