Prognostic Model Heart Failure

Last updated: May 10, 2024
Sponsor: National Institute of Cardiovascular Diseases, Pakistan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Hyponatremia

Treatment

Acute Heart Failure

Clinical Study ID

NCT06414928
IRB-63/2023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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)

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Acute Heart Failure
Phase:
Study Start date:
February 14, 2024
Estimated Completion Date:
June 14, 2026

Study 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).

Connect with a study center

  • National Institute of Cardiovascular Diseases

    Karachi, Sindh 75510
    Pakistan

    Active - Recruiting

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