NCT02047526

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

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

8 months

First QC Date

February 6, 2013

Last Update Submit

January 27, 2014

Conditions

Heart Failure

Keywords

Heart FailureCardiovascular diseaseCongestive Heart Failure

Outcome Measures

Primary Outcomes (4)

  • Cardiovascular hospitalization rates and Length of stay

    1 year

  • HF related Hospitalization and hospital visits

    1 year

  • Cardiovascular and all cause mortality

    1 year

  • Change in Minnesota Living with Heart Failure Questionnaire scores.

    1 year

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with Dyspnea and/or signs of systemic congestion

You may qualify if:

  • Provision of subject informed consent
  • Female or male aged 18 years and over
  • All patients with Dyspnea and/or signs of systemic congestion

You may not qualify if:

  • Subjects with Current Acute Coronary Syndrome
  • Absence of cardiac disease/structural heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart FailureCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

  • Ammar Raza, MBBS, DIP DIAB, MBA

    AstraZeneca Pharma India Ltd.

    STUDY DIRECTOR

  • R R Kasliwal, DM

    Medanta, The Medicity, Gurgaon

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2013

First Posted

January 28, 2014

Study Start

November 1, 2013

Primary Completion

July 1, 2014

Last Updated

January 28, 2014

Record last verified: 2014-01