Prognostic Model Heart Failure

NCT ID: NCT06414928

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-14

Study Completion Date

2026-06-14

Brief Summary

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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

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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).

Conditions

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Heart Failure Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Acute Heart Failure

Consecutive patients presented at Emergency Departement with Acute Heart Failure

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiovascular Diseases, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Madiha Fatima

Senior Registrar Emergency

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madiha Fatima, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiovascular Diseases

Locations

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National Institute of Cardiovascular Diseases

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Madiha Fatima, MBBS, FCPS

Role: CONTACT

+923452325663

Rajesh Kumar, MBBS, FCPS

Role: CONTACT

+923337306090

Facility Contacts

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Madiha Fatima, MBBS, FCPS

Role: primary

+923452325663

Rajesh Kumar, MBBS, FCPS

Role: backup

+923337306090

Other Identifiers

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IRB-63/2023

Identifier Type: -

Identifier Source: org_study_id

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