Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414928
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-10
Brief Title:
Prognostic Model Heart Failure
Sponsor:
National Institute of Cardiovascular Diseases Pakistan
Organization:
National Institute of Cardiovascular Diseases Pakistan
Study Overview
Official Title:
In-hospital 30-day Prognostication of Acute Heart Failure Patients by Comparing 4 Validated Scores in Patients Presenting to the Emergency Department of Cardiac Tertiary Care Hospital Karachi- Pakistan
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to determine the prognosis of heart failure in our population by using multiple validated risk scores and to evaluate the strengths of these scores in assessing prognosis with better discrimination
Detailed Description:
After fulfilling the eligibility criteria informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity All the included patients will be interviewed by the assigned physician to complete the detailed questionnaire including patient demographics risk factors and validated questionnaires including the Acute Decompensated Heart Failure National Registry ADHERE The Get With The Guideline-Heart Failure GWTG-HF Risk Score the Ottawa Heart Failure Risk Scale OHFRS and EHMRG30-ST score All the patients will be followed after 30 days and survival status will be obtained The AUC of the GWTG-HF risk score for all-cause death was 0687 95 CI 0649-0725 18 at 95 confidence interval 3 margin of error the sample size was calculated to be n626 patients The calculated sample size was inflated by a factor of 15 for the design effect hence the sample size for the study will be N939
For data verification 10 of the data will be cross-checked with the source document Patient file
For data verification 10 of the data will be cross-checked with the source document Patient file
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None