Prognostic Model Heart Failure

Heart Failure Acute Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06414928
• Other study ID #: IRB-63/2023
• Status: Recruiting
• Start date: February 14, 2024
• Est. completion date: June 14, 2026

Study information

• Verified date: May 2024
• Source: National Institute of Cardiovascular Diseases, Pakistan
• Contact: Madiha Fatima, MBBS, FCPS
• Phone: +923452325663
• Email: madihafatima89[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 14, 2026
• Est. primary completion date: February 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Acute

Intervention

Other:
• Acute Heart Failure
Consecutive patients presented at Emergency Departement with Acute Heart Failure

Locations

Country	Name	City	State
Pakistan	National Institute of Cardiovascular Diseases	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiovascular Diseases, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-Hospital Prognosis	Factors affecting in-hospital prognosis of patients with acute heart failure presented at Emergency of a tertiary care hospital	From admission till discharge/death
Primary	30-day Prognosis	Factors affecting the 30-day prognosis of patients with acute heart failure either via telephonic contact or re-admission or via OPD.	From day of admission of last visit till 30 days