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

      • Kuwait City, Kuwait
        • Adan hospital
      • Kuwait City, Kuwait
        • Amiri Hospital
      • Kuwait City, Kuwait
        • Chest Hospital
      • Kuwait City, Kuwait
        • Farwanya Hospital
      • Kuwait City, Kuwait
        • Mubarak Al Kabeer

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:

  1. Is over the age of 21.
  2. Has been diagnosed with heart failure, regardless of cause.
  3. Is presenting to the outpatient clinic of an internist or cardiologist for follow up.
  4. Provides a written consent.

Exclusion Criteria:

  1. Prior enrolment in this study.
  2. 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
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)
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
Single time point at baseline upon inclusion (cross-sectional)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure investigations that heart failure patients undergo
Time Frame: Up to 6 months before inclusion
Number of participants who have had echocardiography done less than 1 month, 1-6 months, greater than 6 months from enrollment
Up to 6 months before inclusion
Measuring patient functional status in heart failure patients
Time Frame: Single time point at baseline upon inclusion (cross-sectional)
  • Number of participants who can walk independently, walk with assistance, or are unable to walk.
  • Number of participants who are limited in dressing, somewhat limited, or not limited.
  • Number of participants who are can shower in a limited manner, somewhat limited, or not limited
Single time point at baseline upon inclusion (cross-sectional)
Relationship between cardiovascular risk factors and heart failure
Time Frame: Single time point at baseline upon inclusion (cross-sectional)
Single time point at baseline upon inclusion (cross-sectional)
Measuring Management Gaps in heart failure patients
Time Frame: Past 12 months upon inclusion
  • Number of participants with 0, 1, 2, or greater than 2 emergency room visits related to heart failure
  • Number of participants with 0,1, 2, or greater than 2 hospital admissions related to heart failure
Past 12 months upon inclusion

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)
Number of participants that will either have preserved or reduced left ventricular systolic function
Single time point at baseline upon inclusion (cross-sectional)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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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