Heart FailureNCT04865406
Forxiga HF General Drug Use-Results Study
An observational study of Heart Failure, run by AstraZeneca at 45 sites in Japan.
Trial summary
To capture safety when Forxiga is administered to patients with HF in clinical practice after launch. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 1,221 participants
- Where
- 45 sitesJapan
- Study dates
- 10 May 2021to 22 Aug 2024
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic heart failure who use Forxiga for the first time.
Who may be able to join
- Patients aged more than 15 years
- Patients who have been prescribed Forxiga for the first time
Who cannot join
- Patients with a history of hypersensitivity to any ingredients of this drug.
- Patients with severe ketosis, diabetic coma or precoma
- Patients with severe infections, before or after a surgery, or with serious trauma
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
Japan45 sites
Research Site
Aichi
Research Site
Akita
Research Site
Aomori
Research Site
Chiba
Research Site
Ehime
Research Site
Fukui
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Gifu
Research Site
Gunma
Research Site
Hiroshima
Research Site
Hokkaido
Research Site
Hyōgo
Research Site
Ibaraki
Research Site
Ishikawa
Research Site
Kagawa
Research Site
Kagoshima
Research Site
Kanagawa
Research Site
Kochi
Research Site
Kumamoto
Research Site
Kyoto
Research Site
Mie
Research Site
Miyagi
Research Site
Miyazaki
Research Site
Nagano
Research Site
Nagasaki
Research Site
Nara
Research Site
Numakunai
Research Site
Ōita
Research Site
Okayama
Research Site
Okinawa
Research Site
Osaka
Research Site
Saga
Research Site
Saitama
Research Site
Shiga
Research Site
Shimane
Research Site
Shizuoka
Research Site
Tochigi
Research Site
Tokushima
Research Site
Tokyo
Research Site
Toyama
Research Site
Wakayama
Research Site
Yamagata
Research Site
Yamaguchi
Research Site
Yamanashi
About this study
Official title: Forxiga Tablets General Drug Use-Results Study in Patients With HF
To capture safety when Forxiga is administered to patients with HF in clinical practice after launch.
Read the detailed description
The purpose of the study is to review the following points during use of Forxiga Tablets (hereinafter referred to as Forxiga) in the real world setting after launch.
- ADRs which are unexpected from the precautions for use
- Understanding of incidence of ADRs during use of Forxiga in the real world setting
- Factors possibly having an impact on the safety
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of adverse drug reactions (ADRs)
Development of ADRs by unexpected from "Precautions for Use" of Forxiga JPI, by SOC, by patient demography and by treatment
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 posted29 Apr 2021
- Study start10 May 2021
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,221 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865406
- Sponsor's protocol ID
- D1699C00017
- Status last verified
- Jun 2025
- First submitted
- 26 Apr 2021
- Last updated
- 3 Jul 2025
- Results posted
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forxiga Tablets General Drug Use-Results Study in Patients With HF
- ClinicalTrials.gov ID
- NCT04865406
- Acronym / sponsor ID
- D1699C00017
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,221 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 29 Apr 2021 (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.
To capture safety when Forxiga is administered to patients with HF in clinical practice after launch.
Detailed description
The purpose of the study is to review the following points during use of Forxiga Tablets (hereinafter referred to as Forxiga) in the real world setting after launch.
- ADRs which are unexpected from the precautions for use
- Understanding of incidence of ADRs during use of Forxiga in the real world setting
- Factors possibly having an impact on the safety
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic heart failure who use Forxiga for the first time.
Key inclusion criteria (2 listed)
- Patients aged more than 15 years
- Patients who have been prescribed Forxiga for the first time
Key exclusion criteria (3 listed)
- Patients with a history of hypersensitivity to any ingredients of this drug.
- Patients with severe ketosis, diabetic coma or precoma
- Patients with severe infections, before or after a surgery, or with serious trauma
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
frequency of adverse drug reactions (ADRs)
Time frame: 1 year
Development of ADRs by unexpected from "Precautions for Use" of Forxiga JPI, by SOC, by patient demography and by treatment
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 3 Jul 2025.
- CSR Synopsis Redacted D1699C00017Link 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.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by AstraZeneca at 45 sites in Japan.
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 2 inclusion and 3 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Japan. 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?
frequency of adverse drug reactions (ADRs) (time frame: 1 year). 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 3 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.