Acute Heart FailureGulfCARENCT01467973
Gulf Acute Heart Failure Registry
An observational study of Acute Heart Failure, run by Gulf Heart Association at 1 site in Oman.
Trial summary
The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(AHF) with 3 month and one year follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- How many people
- 5,005 participants
- Where
- 1 siteOman
- Study dates
- Feb 2012to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to various hospitals in the Middle-East with acute heart failure.
Who may be able to join
- Clinical diagnosis of acute heart failure
- Admitted to the participating hospitals
Who cannot join
- Patients with acute heart failure who are discharged from the emergency room without admission.
- Patients transferred from non-registry hospital
- Failure to obtain informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gulf aCute heArt failuRe rEgistry (Gulf CARE)
The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(AHF) with 3 month and one year follow-up.
Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable medical practices and heart failure management setup in the Gulf region, AHF patients in the Gulf states are expected to have different presentation and receive different management than patients in European countries resulting in different outcome. It is also hypothesized that there is considerable gap between heart failure management guidelines and clinical practices in the Gulf region.
Read the detailed description
The Gulf Heart Association (GHA) initiated Gulf acute heart failure registry (Gulf CARE)is designed to assess epidemiology, clinical data, management and outcomes of AHF in six Gulf countries and whether published, professional guidelines on the diagnosis and treatment of heart failure are being applied appropriately in patients with heart failure. The registry will also provide a quantitative estimate as well as qualitative description of the hospital disease activity related to heart failure. The information gathered will identify management gaps in diagnosis and care of AHF patients that may be addressed by more effective implementation of current guidelines or development of AHF guidelines which may be appropriate to this region. Findings from this registry may help in knowing the current status of heart transplantation in the Middle-East countries as well as identify issues in establishing future heart transplant programme including selection of appropriate candidates and donors, requirements for pre- and post-transplant support.
- Conditions
- Acute Heart Failure
- Keywords
- Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic, Middle-East
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of acute heart failure in the Middle-East
To describe the epidemiology, etiology, precipitating factors, demographics, clinical characteristics, management and outcome of patients admitted with acute heart failure in the Middle-East.
Measured: One year
Secondary outcomes (1)
To identify targets for the long term objectives of improving quality of care in acute heart failure patients from the Middle-East
To identify targets for the long term objectives of improving quality of care, reducing morbidity and mortality and lowering the cost of managing patients with acute heart failure in the Middle-East
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Heart Association
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Sponsor
- Investigators
- Kadhim J Sulaiman, FRCPI, Principal investigator, Royal Hospital, Muscat, OmanPrashanth Panduranga, FRCP(Edin), Study director, Royal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467973
- Sponsor's protocol ID
- GHA4
- Acronym
- GulfCARE
- Status last verified
- Apr 2014
- First submitted
- 7 Nov 2011
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jan RK, Alsheikh-Ali A, Mulla AA, Sulaiman K, Panduranga P, Al-Mahmeed W, Bazargani N, Al-Suwaidi J, Al-Jarallah M, Al-Motarreb A, Salam A, Al-Zakwani I. Outcomes of guideline-based medical therapy in patients with acute heart failure and reduced left ventricular ejection fraction: Observations from the Gulf acute heart failure registry (Gulf CARE). Medicine (Baltimore). 2022 Jun 10;101(23):e29452. doi: 10.1097/MD.0000000000029452.
PubMed 35687781Doi SA, Islam N, Sulaiman K, Alsheikh-Ali AA, Singh R, Al-Qahtani A, Asaad N, AlHabib KF, Al-Zakwani I, Al-Jarallah M, AlMahmeed W, Bulbanat B, Bazargani N, Amin H, Al-Motarreb A, AlFaleh H, Panduranga P, Shehab A, Al Suwaidi J, Salam AM. Demystifying Smoker's Paradox: A Propensity Score-Weighted Analysis in Patients Hospitalized With Acute Heart Failure. J Am Heart Assoc. 2019 Dec 3;8(23):e013056. doi: 10.1161/JAHA.119.013056. Epub 2019 Nov 29.
PubMed 31779564Al-Zakwani I, Sulaiman K, Al-Lawati JA, Alsheikh-Ali AA, Panduranga P, Al-Habib KF, Al Suwaidi J, Al-Mahmeed W, Al-Faleh H, Elasfar A, Al-Motarreb A, Ridha M, Bulbanat B, Al-Jarallah M, Bazargani N, Asaad N, Amin H. Impact of Angiotensin Converting Enzyme Inhibitors/Angiotensin Receptors Blockers on Mortality in Acute Heart Failure Patients with Left Ventricular Systolic Dysfunction in the Middle East: Observations from the Gulf Acute Heart Failure Registry (Gulf CARE). Curr Vasc Pharmacol. 2018;16(6):596-602. doi: 10.2174/1570161115666170817164420.
PubMed 28820057Abi Khalil C, Sulaiman K, Mahfoud Z, Singh R, Asaad N, AlHabib KF, Alsheikh-Ali A, Al-Jarallah M, Bulbanat B, AlMahmeed W, Ridha M, Bazargani N, Amin H, Al-Motarreb A, Faleh HA, Elasfar A, Panduranga P, Suwaidi JA; GULF-CARE group. Non-withdrawal of beta blockers in acute decompensated chronic and de novo heart failure with reduced ejection fraction in a prospective multicentre study of patients with acute heart failure in the Middle East. BMJ Open. 2017 Jul 9;7(7):e014915. doi: 10.1136/bmjopen-2016-014915.
PubMed 28694343Khafaji HA, Sulaiman K, Singh R, AlHabib KF, Asaad N, Alsheikh-Ali A, Al-Jarallah M, Bulbanat B, AlMahmeed W, Ridha M, Bazargani N, Amin H, Al-Motarreb A, AlFaleh H, Elasfar A, Panduranga P, Al Suwaidi J. Clinical characteristics, precipitating factors, management and outcome of patients with prior stroke hospitalised with heart failure: an observational report from the Middle East. BMJ Open. 2015 Apr 23;5(4):e007148. doi: 10.1136/bmjopen-2014-007148.
PubMed 25908674
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gulf aCute heArt failuRe rEgistry (Gulf CARE)
- ClinicalTrials.gov ID
- NCT01467973
- Acronym / sponsor ID
- GulfCARE / GHA4
- Conditions
- Acute Heart Failure
- Keywords
- Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic, Middle-East
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,005 participants (actual)
- Lead sponsor
- Gulf Heart AssociationUniversity, hospital or other
- Collaborators
- Servier
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Nov 2011 (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.
The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(AHF) with 3 month and one year follow-up.
Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable medical practices and heart failure management setup in the Gulf region, AHF patients in the Gulf states are expected to have different presentation and receive different management than patients in European countries resulting in different outcome. It is also hypothesized that there is considerable gap between heart failure management guidelines and clinical practices in the Gulf region.
Detailed description
The Gulf Heart Association (GHA) initiated Gulf acute heart failure registry (Gulf CARE)is designed to assess epidemiology, clinical data, management and outcomes of AHF in six Gulf countries and whether published, professional guidelines on the diagnosis and treatment of heart failure are being applied appropriately in patients with heart failure. The registry will also provide a quantitative estimate as well as qualitative description of the hospital disease activity related to heart failure. The information gathered will identify management gaps in diagnosis and care of AHF patients that may be addressed by more effective implementation of current guidelines or development of AHF guidelines which may be appropriate to this region. Findings from this registry may help in knowing the current status of heart transplantation in the Middle-East countries as well as identify issues in establishing future heart transplant programme including selection of appropriate candidates and donors, requirements for pre- and post-transplant support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to various hospitals in the Middle-East with acute heart failure.
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute heart failure
- Admitted to the participating hospitals
Key exclusion criteria (3 listed)
- Patients with acute heart failure who are discharged from the emergency room without admission.
- Patients transferred from non-registry hospital
- Failure to obtain informed 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
Study of acute heart failure in the Middle-East
Time frame: One year
To describe the epidemiology, etiology, precipitating factors, demographics, clinical characteristics, management and outcome of patients admitted with acute heart failure in the Middle-East.
1 secondary outcome
To identify targets for the long term objectives of improving quality of care in acute heart failure patients from the Middle-East
Time frame: One year
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 22 Apr 2014.
- Derived from this study: PubMed 35687781Jan RK, Alsheikh-Ali A, Mulla AA, Sulaiman K, Panduranga P, Al-Mahmeed W, Bazargani N, Al-Suwaidi J, Al-Jarallah M, Al-Motarreb A, Salam A, Al-Zakwani I. Outcomes of guideline-based medical therapy in patients with acute heart failure and reduced left ventricular ejection fraction: Observations from the Gulf acute heart failure registry (Gulf CARE). Medicine (Baltimore). 2022 Jun 10;101(23):e29452. doi: 10.1097/MD.0000000000029452.
- Derived from this study: PubMed 31779564Doi SA, Islam N, Sulaiman K, Alsheikh-Ali AA, Singh R, Al-Qahtani A, Asaad N, AlHabib KF, Al-Zakwani I, Al-Jarallah M, AlMahmeed W, Bulbanat B, Bazargani N, Amin H, Al-Motarreb A, AlFaleh H, Panduranga P, Shehab A, Al Suwaidi J, Salam AM. Demystifying Smoker's Paradox: A Propensity Score-Weighted Analysis in Patients Hospitalized With Acute Heart Failure. J Am Heart Assoc. 2019 Dec 3;8(23):e013056. doi: 10.1161/JAHA.119.013056. Epub 2019 Nov 29.
- Derived from this study: PubMed 28820057Al-Zakwani I, Sulaiman K, Al-Lawati JA, Alsheikh-Ali AA, Panduranga P, Al-Habib KF, Al Suwaidi J, Al-Mahmeed W, Al-Faleh H, Elasfar A, Al-Motarreb A, Ridha M, Bulbanat B, Al-Jarallah M, Bazargani N, Asaad N, Amin H. Impact of Angiotensin Converting Enzyme Inhibitors/Angiotensin Receptors Blockers on Mortality in Acute Heart Failure Patients with Left Ventricular Systolic Dysfunction in the Middle East: Observations from the Gulf Acute Heart Failure Registry (Gulf CARE). Curr Vasc Pharmacol. 2018;16(6):596-602. doi: 10.2174/1570161115666170817164420.
- Derived from this study: PubMed 28694343Abi Khalil C, Sulaiman K, Mahfoud Z, Singh R, Asaad N, AlHabib KF, Alsheikh-Ali A, Al-Jarallah M, Bulbanat B, AlMahmeed W, Ridha M, Bazargani N, Amin H, Al-Motarreb A, Faleh HA, Elasfar A, Panduranga P, Suwaidi JA; GULF-CARE group. Non-withdrawal of beta blockers in acute decompensated chronic and de novo heart failure with reduced ejection fraction in a prospective multicentre study of patients with acute heart failure in the Middle East. BMJ Open. 2017 Jul 9;7(7):e014915. doi: 10.1136/bmjopen-2016-014915.
- Derived from this study: PubMed 25908674Khafaji HA, Sulaiman K, Singh R, AlHabib KF, Asaad N, Alsheikh-Ali A, Al-Jarallah M, Bulbanat B, AlMahmeed W, Ridha M, Bazargani N, Amin H, Al-Motarreb A, AlFaleh H, Elasfar A, Panduranga P, Al Suwaidi J. Clinical characteristics, precipitating factors, management and outcome of patients with prior stroke hospitalised with heart failure: an observational report from the Middle East. BMJ Open. 2015 Apr 23;5(4):e007148. doi: 10.1136/bmjopen-2014-007148.
Related trials for Acute Heart Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
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.
Kadhim J Sulaiman, FRCPI principal investigator
Royal Hospital, Muscat, Oman
Prashanth Panduranga, FRCP(Edin) study director
Royal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by Gulf Heart Association at 1 site in Oman.
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 2 inclusion and 3 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 22 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. 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?
Study of acute heart failure in the Middle-East (time frame: One year). 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 NCT01467973, which also lists 5 linked publications.
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 22 Apr 2014.