Heart FailureDYSPNEANCT02793180
Documentation of Heart Failure in a Gulf Registry
An observational study of Heart Failure, run by Gulf Heart Association at 5 sites in Kuwait.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 3,680 participants
- Where
- 5 sitesKuwait
- Study dates
- 7 Nov 2016to 19 Feb 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Prior enrolment in this study.
- Refusal or inability to provide consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Kuwait5 sites
Adan Hospital
Kuwait City
Amiri Hospital
Kuwait City
Chest Hospital
Kuwait City
Farwanya Hospital
Kuwait City
Mubarak Al Kabeer
Kuwait City
About this study
Official title: 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.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Single time point at baseline upon inclusion (cross-sectional)
Secondary outcomes (4)
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
Measured: Up to 6 months before inclusion
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
Measured: Single time point at baseline upon inclusion (cross-sectional)
Relationship between cardiovascular risk factors and heart failure
Measured: Single time point at baseline upon inclusion (cross-sectional)
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
Measured: Past 12 months upon inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start7 Nov 2016
- Primary completion19 Feb 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 3,680 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gulf Heart Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Zubaid, Principal investigator, Gulf Heart Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793180
- Sponsor's protocol ID
- CLCZ696BKW01T
- Acronym
- DYSPNEA
- Status last verified
- May 2018
- First submitted
- 15 May 2016
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31007855
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gulf Documentation of Ambulatory Sick Patients With Heart Failure Registry
- ClinicalTrials.gov ID
- NCT02793180
- Acronym / sponsor ID
- DYSPNEA / CLCZ696BKW01T
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,680 participants (actual)
- Lead sponsor
- Gulf Heart AssociationUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Prior enrolment in this study.
- Refusal or inability to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Measure investigations that heart failure patients undergo
Time frame: 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)
Relationship between cardiovascular risk factors and heart failure
Time frame: Single time point at baseline upon inclusion (cross-sectional)
Measuring Management Gaps in heart failure patients
Time frame: Past 12 months upon inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 31007855Zubaid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Zubaid principal investigator
Gulf Heart Association
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Gulf Heart Association at 5 sites in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.