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

Sponsor
AstraZeneca (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02047526
Collaborator
(none)
0
Enrollment

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Time Perspective:
    Prospective
    Official Title:
    A Non-interventional, Prospective Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in India
    Study Start Date :
    Nov 1, 2013
    Anticipated Primary Completion Date :
    Jul 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Outcome Measures

    Primary Outcome Measures

    1. Cardiovascular hospitalization rates and Length of stay [1 year]

    2. HF related Hospitalization and hospital visits [1 year]

    3. Cardiovascular and all cause mortality [1 year]

    4. Change in Minnesota Living with Heart Failure Questionnaire scores. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Ammar Raza, MBBS, DIP DIAB, MBA, AstraZeneca Pharma India Ltd.
    • Principal Investigator: R R Kasliwal, DM, Medanta, The Medicity, Gurgaon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT02047526
    Other Study ID Numbers:
    • NIS-CIN-XXX-2012/1
    • HF Registry-India
    First Posted:
    Jan 28, 2014
    Last Update Posted:
    Jan 28, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by AstraZeneca
    Heart Failure
    Cardiovascular disease
    Congestive Heart Failure
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jan 28, 2014