Heart FailureNCT02047526
A Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in India
An observational study of Heart Failure, run by AstraZeneca.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with Dyspnea and/or signs of systemic congestion
Who may be able to join
- Provision of subject informed consent
- Female or male aged 18 years and over
- All patients with Dyspnea and/or signs of systemic congestion
Who cannot join
- Subjects with Current Acute Coronary Syndrome
- Absence of cardiac disease/structural heart disease
About this study
Official title: A Non-interventional, Prospective Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in India
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
Read the detailed description
A non-interventional, prospective study to evaluate the clinical epidemiology of patients with Heart Failure (HF) in India
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiovascular disease, Congestive Heart Failure
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular hospitalization rates and Length of stay
Measured: 1 year
HF related Hospitalization and hospital visits
Measured: 1 year
Cardiovascular and all cause mortality
Measured: 1 year
Change in Minnesota Living with Heart Failure Questionnaire scores.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ammar Raza, MBBS, DIP DIAB, MBA, Study director, AstraZeneca Pharma India Ltd.R R Kasliwal, DM, Principal investigator, Medanta, The Medicity, Gurgaon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047526
- Sponsor's protocol ID
- NIS-CIN-XXX-2012/1
- Other IDs
- HF Registry-India
- Status last verified
- Jan 2014
- First submitted
- 6 Feb 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Prospective Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in India
- ClinicalTrials.gov ID
- NCT02047526
- Acronym / sponsor ID
- NIS-CIN-XXX-2012/1
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiovascular disease, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (estimated)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with Dyspnea and/or signs of systemic congestion
Key inclusion criteria (3 listed)
- Provision of subject informed consent
- Female or male aged 18 years and over
- All patients with Dyspnea and/or signs of systemic congestion
Key exclusion criteria (2 listed)
- Subjects with Current Acute Coronary Syndrome
- Absence of cardiac disease/structural heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular hospitalization rates and Length of stay
Time frame: 1 year
HF related Hospitalization and hospital visits
Time frame: 1 year
Cardiovascular and all cause mortality
Time frame: 1 year
Change in Minnesota Living with Heart Failure Questionnaire scores.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammar Raza, MBBS, DIP DIAB, MBA study director
AstraZeneca Pharma India Ltd.
R R Kasliwal, DM principal investigator
Medanta, The Medicity, Gurgaon
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular hospitalization rates and Length of stay (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.