Type 2 DiabetesHF-RegistryNCT04072523
An Observational Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients
An observational study of Type 2 Diabetes, run by AstraZeneca at 26 sites in India.
Trial summary
An Observational Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 621 participants
- Where
- 26 sitesIndia
- Study dates
- 3 Dec 2019to 1 Mar 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: type 2 diabetes mellitus patients
Who may be able to join
- Both men and women aged ≥ 18 years
- Diagnosed with type 2 diabetes (as per ADA Criteria)
- Duration of diabetes for 1 year or more
- Willing to provide the informed consent
Who cannot join
- Patients with evidence of coronary artery disease - CAD (based on the clinical expertise of the physician).
- Patients who were previously diagnosed with heart failure.
- Patients with evidence of valvular disease based on clinical judgement of the Principle Investigator (PI).
- Current treatment with digoxin.
- History of symptoms of peripheral artery disease, chronic obstructive pulmonary disease and arrhythmias.
- Patients diagnosed with stage III/IV CKD
- Diabetes other than type 2 diabetes mellitus.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
India26 sites
Research Site
Ahemdabad, Gujarat, 380013
Research Site
Amritsar, Punjab, 143001
Research Site
Bangalore, Karnataka, 560043
Research Site
Bangalore, Karnataka, 560094
Research Site
Chandigarh, Punjab, 160011
Research Site
Chennai, Tamil Nadu, 600024
Research Site
Chennai, Tamil Nadu, 600040
Research Site
Delhi, New Delhi, 110007
Research Site
Delhi, New Delhi, 110085
Research Site
Delhi, 110026
Research Site
Delhi, 110085
Research Site
Hyderabad, Telangana, 500047
Research Site
Hyderabad, Telangana, 500059
Research Site
Jalandhar, Punjab, 144001
Research Site
Kanpur, Uttar Pradesh, 208001
Research Site
Kanpur, Uttar Pradesh, 208002
Research Site
Kochi, Kerala, 682020
Research Site
Kolkata, West Bengal, 700019
Research Site
Kolkata, West Bengal, 700029
Research Site
Kolkata, West Bengal, 700050
Research Site
Kolkata, West Bengal, 700054
Research Site
Kolkata, West Bengal, 700064
Research Site
Ludhiana, Punjab, 141001
Research Site
Mumbai, Maharashtra, 400081
Research Site
Rajkot, Gujarat, 360001
Research Site
Rohtak, Haryana, 124001
About this study
Official title: An Observational, Cross Sectional Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India
An Observational Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India.
Read the detailed description
This is a cross sectional, observational, multi-centre study to be conducted at 40 centres in India. The study targets to enrol 1000 patients with approx. 25 patients per site. The study would enrol Type 2 Diabetes Mellitus patients who provide written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Heart Failure
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure
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 |
|---|---|---|
| Observational Study Investigational Product NA | Patients : Type 2 Diabetic Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Left Ventricular dysfunction
based on the BNP levels and echocardiography results.
Measured: 1 day
Secondary outcomes (1)
Correlation of Left ventricular dysfunction and heart failure
With demographics and comorbidities of the patients to assess relation between them.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start3 Dec 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072523
- Sponsor's protocol ID
- D1843R00300
- Acronym
- HF-Registry
- Status last verified
- Feb 2022
- First submitted
- 27 Aug 2019
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Cross Sectional Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India
- ClinicalTrials.gov ID
- NCT04072523
- Acronym / sponsor ID
- HF-Registry / D1843R00300
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- 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.
An Observational Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India.
Detailed description
This is a cross sectional, observational, multi-centre study to be conducted at 40 centres in India. The study targets to enrol 1000 patients with approx. 25 patients per site. The study would enrol Type 2 Diabetes Mellitus patients who provide written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Study Investigational Product NA | – | –Patients : Type 2 Diabetic Patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- type 2 diabetes mellitus patients
Key inclusion criteria (4 listed)
- Both men and women aged ≥ 18 years
- Diagnosed with type 2 diabetes (as per ADA Criteria)
- Duration of diabetes for 1 year or more
- Willing to provide the informed consent
Key exclusion criteria (7 listed)
- Patients with evidence of coronary artery disease - CAD (based on the clinical expertise of the physician).
- Patients who were previously diagnosed with heart failure.
- Patients with evidence of valvular disease based on clinical judgement of the Principle Investigator (PI).
- Current treatment with digoxin.
- History of symptoms of peripheral artery disease, chronic obstructive pulmonary disease and arrhythmias.
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
Prevalence of Left Ventricular dysfunction
Time frame: 1 day
based on the BNP levels and echocardiography results.
1 secondary outcome
Correlation of Left ventricular dysfunction and heart failure
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by AstraZeneca at 26 sites in India.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of Left Ventricular dysfunction (time frame: 1 day). 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 4 Mar 2022.