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Clinical Trials/NCT06414928
NCT06414928
Recruiting
Not Applicable

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

National Institute of Cardiovascular Diseases, Pakistan1 site in 1 country1,000 target enrollmentFebruary 14, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure Acute
Sponsor
National Institute of Cardiovascular Diseases, Pakistan
Enrollment
1000
Locations
1
Primary Endpoint
In-Hospital Prognosis
Status
Recruiting
Last Updated
last year

Overview

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 0.687 (95% CI, 0.649-0.725) \[18\], at 95% confidence interval, ±3% margin of error, the sample size was calculated to be n=626 patients. The calculated sample size was inflated by a factor of 1.5 for the design effect; hence, the sample size for the study will be N=939. For data verification, 10% of the data will be cross-checked with the source document (Patient file).

Registry
clinicaltrials.gov
Start Date
February 14, 2024
End Date
June 14, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Madiha Fatima

Senior Registrar Emergency

National Institute of Cardiovascular Diseases, Pakistan

Eligibility Criteria

Inclusion Criteria

  • Patients of age \> 18 years or more
  • Either gender
  • Patients visited the emergency department at NICVD, Karachi
  • Newly/Already diagnosed with Heart Failure
  • Giving informed consent
  • Who can be followed in 30 days via Telephone or in OPD

Exclusion Criteria

  • Patients of age \<18 years
  • Patients who do not give consent
  • Patients who are mentally handicapped due to any neurological or psychiatric illness (excluding depression/anxiety)

Outcomes

Primary Outcomes

In-Hospital Prognosis

Time Frame: From admission till discharge/death

Factors affecting in-hospital prognosis of patients with acute heart failure presented at Emergency of a tertiary care hospital

30-day Prognosis

Time Frame: From day of admission of last visit till 30 days

Factors affecting the 30-day prognosis of patients with acute heart failure either via telephonic contact or re-admission or via OPD.

Study Sites (1)

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