A Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in India

Heart Failure Clinical Trial

Official title:

A Non-interventional, Prospective Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in India

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02047526
• Other study ID #: NIS-CIN-XXX-2012/1
• Secondary ID: HF Registry-Indi
• Status: Withdrawn
• Phase: N/A
• First received: February 6, 2013
• Last updated: January 27, 2014
• Start date: November 2013

Study information

• Verified date: January 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: India : Ethics Committee
• Study type: Observational

Clinical Trial Summary

This non-interventional, prospective, multi-centric, cross-sectional study is aimed to observe clinical practice in India in managing Heart Failure patients & to check one year outcome in HF patients. A total of 5 visits will be conducted during the study. There will be a baseline visit followed by four follow-up visits to assess the outcomes

Description:

A non-interventional, prospective study to evaluate the clinical epidemiology of patients with Heart Failure (HF) in India

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision of subject informed consent

2. Female or male aged 18 years and over

3. All patients with Dyspnea and/or signs of systemic congestion

Exclusion Criteria:

1. Subjects with Current Acute Coronary Syndrome

2. Absence of cardiac disease/structural heart disease

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular hospitalization rates and Length of stay		1 year	No
Primary	HF related Hospitalization and hospital visits		1 year	No
Primary	Cardiovascular and all cause mortality		1 year	No
Primary	Change in Minnesota Living with Heart Failure Questionnaire scores.		1 year	No