## Protocol Section
### Identification Module
**NCT ID:** NCT06414928

**Brief Title:** Prognostic Model Heart Failure

**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

#### Organization Study ID Info
**ID:** IRB-63/2023
#### Organization
**Class:** OTHER
**Full Name:** National Institute of Cardiovascular Diseases, Pakistan
### Status Module
#### Completion Date
**Date:** 2026-06-14

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-02-14

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Institute of Cardiovascular Diseases, Pakistan

#### Responsible Party

**Investigator Affiliation:** National Institute of Cardiovascular Diseases, Pakistan

**Investigator Full Name:** Madiha Fatima

**Investigator Title:** Senior Registrar Emergency

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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).

### Conditions Module

**Conditions:**

- Heart Failure Acute

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 30 Days

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Consecutive patients presented at Emergency Departement with Acute Heart Failure

**Name:** Acute Heart Failure

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Factors affecting in-hospital prognosis of patients with acute heart failure presented at Emergency of a tertiary care hospital

**Measure:** In-Hospital Prognosis

**Time Frame:** From admission till discharge/death

**Description:** Factors affecting the 30-day prognosis of patients with acute heart failure either via telephonic contact or re-admission or via OPD.

**Measure:** 30-day Prognosis

**Time Frame:** From day of admission of last visit till 30 days

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** madihafatima89@hotmail.com

**Name:** Madiha Fatima, MBBS, FCPS

**Phone:** +923452325663

**Role:** CONTACT

**Contact 2:**

**Email:** rajeshnarsoolal@gmail.com

**Name:** Rajesh Kumar, MBBS, FCPS

**Phone:** +923337306090

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Karachi

**Contacts:**

***Contact 1:***

- **Email:** madihafatima89@hotmail.com

- **Name:** Madiha Fatima, MBBS, FCPS

- **Phone:** +923452325663

- **Role:** CONTACT

***Contact 2:***

- **Email:** rajeshnarsoolal@gmail.com

- **Name:** Rajesh Kumar, MBBS, FCPS

- **Phone:** +923337306090

- **Role:** CONTACT

**Country:** Pakistan

**Facility:** National Institute of Cardiovascular Diseases

**State:** Sindh

**Status:** RECRUITING

**Zip:** 75510

#### Overall Officials

**Official 1:**

**Affiliation:** National Institute of Cardiovascular Diseases

**Name:** Madiha Fatima, MBBS, FCPS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** The Hospital Medical Record number will be used as the patient identifier.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: LOW

- As Found: Unknown

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-31
