NCT02793180

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,680

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

November 7, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

May 15, 2016

Last Update Submit

May 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quantifying the causes of heart failure in the ambulatory patients in the outpatient setting

    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 Outcomes (4)

  • Measure investigations that heart failure patients undergo

    Up to 6 months before inclusion

  • Measuring patient functional status in heart failure patients

    Single time point at baseline upon inclusion (cross-sectional)

  • Relationship between cardiovascular risk factors and heart failure

    Single time point at baseline upon inclusion (cross-sectional)

  • Measuring Management Gaps in heart failure patients

    Past 12 months upon inclusion

Other Outcomes (1)

  • Quantifying the distribution of heart failure types

    Single time point at baseline upon inclusion (cross-sectional)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Prior enrolment in this study.
  • Refusal or inability to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Adan Hospital

Kuwait City, Kuwait

Location

Amiri Hospital

Kuwait City, Kuwait

Location

Chest Hospital

Kuwait City, Kuwait

Location

Farwanya Hospital

Kuwait City, Kuwait

Location

Mubarak Al Kabeer

Kuwait City, Kuwait

Location

Related Publications (1)

  • Zubaid M, Rashed W, Ridha M, Al-Jarallah M, Hamad A, Al Banna R, Sulaiman K, Bazargani N, Almahmeed W, Al Mulla A, Baslaib F, Asaad N, Attur S. Design and Rationale of Gulf Documentation of Ambulatory Sick Patients with Heart Failure (Gulf DYSPNEA) Registry. Heart Views. 2018 Jul-Sep;19(3):81-84. doi: 10.4103/HEARTVIEWS.HEARTVIEWS_9_18.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mohammad Zubaid

    Gulf Heart Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2016

First Posted

June 8, 2016

Study Start

November 7, 2016

Primary Completion

February 19, 2018

Study Completion

February 19, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations