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临床试验/NCT06414928
NCT06414928招募中不适用

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

National Institute of Cardiovascular Diseases, Pakistan1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
In-Hospital Prognosis

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

In-Hospital Prognosis

时间窗: From admission till discharge/death

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

30-day Prognosis

时间窗: From day of admission of last visit till 30 days

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Madiha Fatima

Senior Registrar Emergency

National Institute of Cardiovascular Diseases, Pakistan

研究点 (1)

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