Clinical trial NCT02793180: Documentation of Heart Failure in a Gulf Registry
Official title: Gulf Documentation of Ambulatory Sick Patients With Heart Failure Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Gulf Heart Association
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 3680
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quantifying the causes of heart failure in the ambulatory patients in the outpatient setting
timeFrame: Single time point at baseline upon inclusion (cross-sectional)
Secondary outcomes:
measure: Measure investigations that heart failure patients undergo
timeFrame: Up to 6 months before inclusion
measure: Measuring patient functional status in heart failure patients
timeFrame: Single time point at baseline upon inclusion (cross-sectional)
measure: Relationship between cardiovascular risk factors and heart failure
timeFrame: Single time point at baseline upon inclusion (cross-sectional)
measure: Measuring Management Gaps in heart failure patients
timeFrame: Past 12 months upon inclusion
Other outcomes:
measure: Quantifying the distribution of heart failure types
timeFrame: Single time point at baseline upon inclusion (cross-sectional)
Locations:
city: Kuwait City
country: Kuwait
facility: Adan Hospital
city: Kuwait City
country: Kuwait
facility: Amiri Hospital
city: Kuwait City
country: Kuwait
facility: Chest Hospital
city: Kuwait City
country: Kuwait
facility: Farwanya Hospital
city: Kuwait City
country: Kuwait
facility: Mubarak Al Kabeer
Study officials:
affiliation: Gulf Heart Association
name: Mohammad Zubaid
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.