A Study to Evaluate the Clinical Epidemiology of Patients... | NCT02047526

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

NCT02047526

Sponsor

AstraZeneca

Status

Withdrawn

Last Update Posted

Jan 28, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HF Registry-India

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jul 2014Estimated

Completion Date

Not provided

First Submitted Date

Feb 6, 2013

First Submission Date that Met QC Criteria

Jan 27, 2014

First Posted Date

Jan 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2014

Last Update Posted Date

Jan 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients with Dyspnea and/or signs of systemic congestion

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided