- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02793180
Documentation of Heart Failure in a Gulf Registry (DYSPNEA)
May 8, 2018 updated by: Gulf Heart Association
Gulf Documentation of Ambulatory Sick Patients With Heart Failure Registry
In the Middle East and the Gulf, the general population have high cardiovascular risks like diabetes, hypertension, smoking and obesity.
The average age of a patient with an acute coronary syndrome (ACS) event is relatively young compared to Western populations.
Women are multiparous and the rates of consanguinity marriages are high in this region of the world.
These risk factors and conditions result in heart failure.
Great deal of knowledge is missing regarding the influence of these risk factors on heart failure presentation, the causes and management of heart failure in ambulatory patients in this region of the world.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
3680
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kuwait City, Kuwait
- Adan hospital
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Kuwait City, Kuwait
- Amiri Hospital
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Kuwait City, Kuwait
- Chest Hospital
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Kuwait City, Kuwait
- Farwanya Hospital
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Kuwait City, Kuwait
- Mubarak Al Kabeer
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
4,000 patients already diagnosed with heart failure.
Expected number of patients from each country: Kuwait 1200, Oman 1200, UAE 600, Bahrain 600 and Qatar 400.
Description
Inclusion Criteria:
- Is over the age of 21.
- Has been diagnosed with heart failure, regardless of cause.
- Is presenting to the outpatient clinic of an internist or cardiologist for follow up.
- Provides a written consent.
Exclusion Criteria:
- Prior enrolment in this study.
- Refusal or inability to provide consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quantifying the causes of heart failure in the ambulatory patients in the outpatient setting
Time Frame: Single time point at baseline upon inclusion (cross-sectional)
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Number of participants with main reason due to heart failure from Coronary Artery Disease (CAD), Hypertension, Valvular, Idiopathic Dilated Cardiomyopathy, Congenital, Pregnancy / delivery related, or other reason to be specified
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Single time point at baseline upon inclusion (cross-sectional)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure investigations that heart failure patients undergo
Time Frame: Up to 6 months before inclusion
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Number of participants who have had echocardiography done less than 1 month, 1-6 months, greater than 6 months from enrollment
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Up to 6 months before inclusion
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Measuring patient functional status in heart failure patients
Time Frame: Single time point at baseline upon inclusion (cross-sectional)
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Single time point at baseline upon inclusion (cross-sectional)
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Relationship between cardiovascular risk factors and heart failure
Time Frame: Single time point at baseline upon inclusion (cross-sectional)
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Single time point at baseline upon inclusion (cross-sectional)
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Measuring Management Gaps in heart failure patients
Time Frame: Past 12 months upon inclusion
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Past 12 months upon inclusion
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantifying the distribution of heart failure types
Time Frame: Single time point at baseline upon inclusion (cross-sectional)
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Number of participants that will either have preserved or reduced left ventricular systolic function
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Single time point at baseline upon inclusion (cross-sectional)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammad Zubaid, Gulf Heart Association
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2016
Primary Completion (Actual)
February 19, 2018
Study Completion (Actual)
February 19, 2018
Study Registration Dates
First Submitted
May 15, 2016
First Submitted That Met QC Criteria
June 2, 2016
First Posted (Estimate)
June 8, 2016
Study Record Updates
Last Update Posted (Actual)
May 9, 2018
Last Update Submitted That Met QC Criteria
May 8, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLCZ696BKW01T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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