Atrial FibrillationPhase 4EMPA-AFNCT04583813
Empagliflozin and Atrial Fibrillation Treatment
A Phase 4 study testing Empagliflozin in people with Atrial Fibrillation and Heart Failure, run by Miulli General Hospital at 1 site in Italy.
Trial summary
The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Heart Failure, Obesity
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2021to Apr 2024
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Diabetes mellitus or Body Mass Index over 25 Kg/m2
- Heart failure
- New York Heart Association (NYHA) Functional Classification: II or III
- Documented atrial fibrillation
- Understands the nature of the study, treatment procedure and provides written informed consent
- Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
- Expected to remain available for at least 24 months after enrollment
Who cannot join
- Permanent atrial fibrillation
- Current use or prior use of a sodium-glucose co-transporter (SGLT) 2 inhibitor or combined inhibitor of SGLT-1 and SGLT-2 (all the other antidiabetic drugs are permitted performing an accurate glycemic control)
- Known allergy or hypersensitivity to any SGLT-2 inhibitors
- History of ketoacidosis
- Need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- New York Heart Association (NYHA) Functional Classification: I or IV
Show all 20Show fewer
- Unstable angina
- Presence of any disease that is likely to shorten life expectancy to < 1 year
- Any cardiac surgery within three months prior to enrolment
- Awaiting cardiac transplantation or other cardiac surgery within the next year
- Myocardial infarction within 60 days prior to enrolment
- Contraindications to oral anticoagulation
- Active systemic infection or sepsis
- Left atrial thrombus (e.g., transesophageal echocardiography, computed tomography and intracardiac echocardiography)
- History of a documented thromboembolic event such as stroke or transient ischemic neurological attack in the three months prior to enrollment
- Currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study
- Chronic liver diseases
- Chronic kidney disease (creatinine clearance < 45 ml/min)
- Pregnant or breast-feeding mothers
- Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trial protocol
Trial locations and contacts
1 site in 1 country.
Italy1 site
Miulli General Hospital
Acquaviva delle Fonti, Bari, 70021
Antonio Di Monaco, MD, +390803054357, a.dimonaco@miulli.it
Massimo Grimaldi, MD
About this study
Official title: Efficacy of Empagliflozin in Patients With Heart Failure and Atrial Fibrillation
The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation.
Read the detailed description
A 24-month randomized, single-blind, placebo-controlled trial to investigate the efficacy of empagliflozin to reduce atrial fibrillation burden in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation in which a rhythm control strategy is indicated.
- Conditions
- Atrial Fibrillation, Heart Failure, Obesity, Diabetes Mellitus
- Being tested
- Empagliflozin, Placebo
- Medical subject headings
- Atrial Fibrillation, Heart Failure, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Empagliflozin 10 mg oral tablet
Empagliflozin 10 mg oral tablet, once daily, for 24 months
PlaceboOther
Also called Placebo oral tablet
Empagliflozin matching placebo, once daily, for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Active comparator | Empagliflozin 10 mg oral tablet, once daily, for 24 months Receives: Drug: Empagliflozin |
| Placebo | Placebo comparator | Empagliflozin matching placebo oral tablet, once daily for 24 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of sinus rhythm after the blanking period
To compare the proportion of patients with sinus rhythm from 90 days after baseline to end of study period
Measured: From 90 days after baseline to 24-months
Secondary outcomes (3)
Composite of major adverse cardiovascular events
To compare the incidence at the end of study period of major adverse cardiovascular events (death, non-fatal myocardial infarction, acute cerebrovascular events)
Measured: Baseline through 24-months
Hospitalizations for cardiovascular events
To compare the incidence at the end of study period of hospitalizations for cardiovascular events
Measured: Baseline through 24-months
Safety endpoint: Incidence of adverse events
To estimate the incidence of adverse events
Measured: Baseline through 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study startSep 2021 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miulli General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Grimaldi, Miulli General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583813
- Sponsor's protocol ID
- MGH_001
- Acronym
- EMPA-AF
- Status last verified
- Apr 2021
- First submitted
- 20 Jul 2020
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Empagliflozin in Patients With Heart Failure and Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04583813
- Acronym / sponsor ID
- EMPA-AF / MGH_001
- Conditions
- Atrial Fibrillation, Heart Failure, Obesity, Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Miulli General HospitalUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 12 Oct 2020 (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.
The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation.
Detailed description
A 24-month randomized, single-blind, placebo-controlled trial to investigate the efficacy of empagliflozin to reduce atrial fibrillation burden in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation in which a rhythm control strategy is indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Active comparator | Drug: EmpagliflozinEmpagliflozin 10 mg oral tablet, once daily, for 24 months |
| Placebo | Placebo comparator | Other: PlaceboEmpagliflozin matching placebo oral tablet, once daily for 24 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-80 years
- Diabetes mellitus or Body Mass Index over 25 Kg/m2
- Heart failure
- New York Heart Association (NYHA) Functional Classification: II or III
- Documented atrial fibrillation
Key exclusion criteria (20 listed)
- Permanent atrial fibrillation
- Current use or prior use of a sodium-glucose co-transporter (SGLT) 2 inhibitor or combined inhibitor of SGLT-1 and SGLT-2 (all the other antidiabetic drugs are permitted performing an accurate glycemic control)
- Known allergy or hypersensitivity to any SGLT-2 inhibitors
- History of ketoacidosis
- Need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: Empagliflozin 10 mg oral tabletEmpagliflozin 10 mg oral tablet, once daily, for 24 months | Drug | Empagliflozin |
| PlaceboAlso: Placebo oral tabletEmpagliflozin matching placebo, once daily, for 24 months | Other | Placebo |
Primary outcome
Maintenance of sinus rhythm after the blanking period
Time frame: From 90 days after baseline to 24-months
To compare the proportion of patients with sinus rhythm from 90 days after baseline to end of study period
3 secondary outcomes
Composite of major adverse cardiovascular events
Time frame: Baseline through 24-months
Hospitalizations for cardiovascular events
Time frame: Baseline through 24-months
Safety endpoint: Incidence of adverse events
Time frame: Baseline through 24-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin in people with Atrial Fibrillation and Heart Failure, run by Miulli General Hospital at 1 site in Italy.
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 8 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Di Monaco, MD (+390803054357, a.dimonaco@miulli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of sinus rhythm after the blanking period (time frame: From 90 days after baseline to 24-months). 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 2 Apr 2021.