Documentation of Heart Failure in a Gulf Registry

Heart Failure Clinical Trial

— DYSPNEA  

Official title:

Gulf Documentation of Ambulatory Sick Patients With Heart Failure Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793180
• Other study ID #: CLCZ696BKW01T
• Status: Completed
• Start date: November 7, 2016
• Est. completion date: February 19, 2018

Study information

• Verified date: May 2018
• Source: Gulf Heart Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3680
• Est. completion date: February 19, 2018
• Est. primary completion date: February 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Kuwait	Adan Hospital	Kuwait City
Kuwait	Amiri Hospital	Kuwait City
Kuwait	Chest Hospital	Kuwait City
Kuwait	Farwanya Hospital	Kuwait City
Kuwait	Mubarak Al Kabeer	Kuwait City

Sponsors (1)

Lead Sponsor	Collaborator
Gulf Heart Association

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantifying the distribution of heart failure types	Number of participants that will either have preserved or reduced left ventricular systolic function	Single time point at baseline upon inclusion (cross-sectional)
Primary	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	Measure investigations that heart failure patients undergo	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
Secondary	Measuring patient functional status in heart failure patients	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)
Secondary	Relationship between cardiovascular risk factors and heart failure		Single time point at baseline upon inclusion (cross-sectional)
Secondary	Measuring Management Gaps in heart failure patients	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