跳至主要内容
临床试验/CTRI/2021/04/032864
CTRI/2021/04/032864招募中不适用

Impact of COVID-19 on Heart Failure Hospitalization and Outcome in India – A Cardiological Society of India Study (CSI-HF in COVID 19 Times Study – “The COVID C-HF Studyâ€)

Cardiological Society of India2 个研究点 分布在 1 个国家目标入组 40,000 人开始时间: 2021年4月19日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40,000
试验地点
2
主要终点
1.To study the change in the number of acute HF admissions in various hospitals in India during the period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019.

研究概览

简要总结

Part 1. Individual patient based acute HF retrospective registry 2020 Vs 2019:

In this multicentric, retrospective, cross-sectional registry, we retrospectively include consecutive patients presenting with acute HF at various participating hospitals across the country during a 6-months period in 2020 (1st of July to 31st December 2020). All cases of acute HF admitted during the corresponding period in the year 2019 will serve as historical controls. Patients with a first acute myocardial infarction in the 2 weeks preceding clinical presentation will be excluded. Patients with alternative diagnoses clearly causative of symptoms will also be excluded. The 2016 European Society of Cardiology (ESC) criteria (12) will be used to define cases of heart failure.

The parameters to be studied include type of HF, new-onset or worsening of pre-existing heart failure, clinical characteristics on index admission, risk factors, etiology for heart failure, history previous myocardial infarction, history of previous hospital admissions, treatment received during hospital admission, diagnostic coronary angiography, percutaneous coronary interventions, and coronary artery bypass graft surgery rates.

Part 2. Hospital statistics on HF-related procedures

We wish to find the differences in the number of various advanced HF procedures. In a predesigned proforma we will collect the total numbers of ICD, CRT, mechanical assist devices including IABP for HF, percutaneous devices, LVAD and heart transplantations performed in the study period in 2020 as compared to corresponding volumes in 2019.

Part 3. Utility of Teleconsultation in HF

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • In this multicentric, retrospective, cross-sectional registry, we plan to retrospectively include consecutive patients presenting with acute HF at various participating hospitals across the Indian states/ union territories during a 6-months period in 2020 (1st of July to 31st December 2020).
  • All cases of acute HF admitted during the corresponding period in the year 2019 will serve as historical controls.The parameters to be studied include type of HF, new-onset or worsening of pre-existing heart failure, clinical characteristics on index admission, risk factors, etiology for heart failure, history previous myocardial infarction, history of previous hospital admissions, treatment received during hospital admission, diagnostic coronary angiography, percutaneous coronary interventions, and coronary artery bypass graft surgery rates.

排除标准

  • Patients with a first acute myocardial infarction in the 2 weeks preceding clinical presentation will be excluded.
  • Patients with alternative diagnoses clearly causative of symptoms will also be excluded.

结局指标

主要结局

1.To study the change in the number of acute HF admissions in various hospitals in India during the period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019.

时间窗: The period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019

2.To study in-hospital mortality rates of ADHF admitted to the various hospitals during the COVID-19 era compared to corresponding period in 2019.

时间窗: The period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019

3.To study care of patients with LVAD and Heart transplant during COVID-19 times

时间窗: The period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019

4.To study the benefits of prophylaxis with HCQ/others

时间窗: The period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019

次要结局

  • 1.To find out type of HF (HFpEF vs HFrEF), and rates of guideline directed medical therapy (GDMT), coronary angiography and revascularization in HF patients.(2.To evaluate the differences in the number of various advanced HF procedures performed in 2020 Vs. 2019 including ICD, CRT, mechanical assist devices and heart transplantation by a survey among the hospitals.)

研究者

申办方类型
Research institution

研究点 (2)

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