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Prognostic Model Heart Failure

N

National Institute of Cardiovascular Diseases, Pakistan

Status

Enrolling

Conditions

Heart Failure Acute

Treatments

Other: Acute Heart Failure

Study type

Observational

Funder types

Other

Identifiers

NCT06414928
IRB-63/2023

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Central trial contact

Rajesh Kumar, MBBS, FCPS; Madiha Fatima, MBBS, FCPS

Data sourced from clinicaltrials.gov

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