Condition category
Circulatory System
Date applied
05/02/2015
Date assigned
07/05/2015
Last edited
29/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

www.qualify-survey.com

Contact information

Type

Scientific

Primary contact

Dr Michel Komajda

ORCID ID

Contact details

Groupe Hospitalier Pitie - Salpetriere
Département de Cardiologie
47/83 boulevard de l'Hôpital
Paris
75013
France

Additional identifiers

EudraCT 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

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

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Heart failure

Intervention

Non-interventional survey

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2013

Overall trial end date

01/09/2018

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial participating centre

547 from 36 countries
-

Sponsor information

Organisation

Servier

Sponsor details

35 rue de Verdun
Suresnes
92284
France

Sponsor type

Industry

Website

www.qualify-survey.com

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

Participant level data

Other

Results - basic reporting

Publication summary

2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27095461

Publication citations

Additional files

Editorial Notes

29/12/2016: The overall trial dates have been updated from 01/09/2013 - 31/01/2017 to 01/01/2013 - 01/09/2018 and the recruitment dates have been updated from 01/10/2013 - 30/03/2015 to 01/09/2013 - 30/12/2014. In addition, the target number of participants has been changed from 7500 to 7092, a publication reference, has been added, as well as the IPD shairng plan. 23/12/2016: The overall trial end date has been updated from 30/12/2015 to 31/01/2017.