Prognostic Model Heart Failure

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure Acute
• Intervention / Treatment: Other: Acute Heart Failure

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).

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Madiha Fatima, MBBS, FCPS; Phone Number: +923452325663; Email: madihafatima89@hotmail.com
• Study Contact Backup: Name: Rajesh Kumar, MBBS, FCPS; Phone Number: +923337306090; Email: rajeshnarsoolal@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75510
      • Recruiting
      • National Institute of Cardiovascular Diseases
      • Contact: Madiha Fatima, MBBS, FCPS; Phone Number: +923452325663; Email: madihafatima89@hotmail.com
      • Contact: Rajesh Kumar, MBBS, FCPS; Phone Number: +923337306090; Email: rajeshnarsoolal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presented at the Emergency Department with signs and symptoms of Acute Heart Failure who are fulfilling the eligibility criteria will be enrolled.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: National Institute of Cardiovascular Diseases, Pakistan
• Investigators: Principal Investigator: Madiha Fatima, MBBS, FCPS, National Institute of Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): February 14, 2026
• Study Completion (Estimated): June 14, 2026

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: IRB-63/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The Hospital Medical Record number will be used as the patient identifier.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No