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HypertensionEarly Phase 1NCT06507657

Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure

A Early Phase 1 study testing empagliflozin in people with Hypertension and Cardiovascular Diseases, run by University of Minnesota at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D). Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hypertension, Cardiovascular Diseases
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
80 participants
Where
1 siteUnited States
Study dates
12 Dec 2024to 15 Jan 2029
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >60 years of age
  • Clinical diagnosis of hypertension
  • Body mass index ≥30kg/m2
  • We will screen for participants with an echocardiogram within 60 days of the baseline visit

Who cannot join

  • Female participants who are pregnant, lactating, or of child bearing potential
  • History of type 1 or type 2 diabetes mellitus by medical history or hemoglobin A1c >7.0% at Visit 1
  • Clinical diagnosis of HFpEF or HFrEF by participant self-report or documented in the electronic health record
  • Any LVEF measure of ≤40% on past echocardiogram
  • Moderate or severe valve disease on echocardiogram
  • History of genitourinary infection
Show all 17Show fewer
  • eGFR <60 ml/min/1.73 m2 at Visit 1
  • Current treatment with SGLT2 inhibitor, GLP1 agonist, or DPP4 inhibitors
  • Participants in whom coronary revascularization by either PCI or bypass surgery is being contemplated within 6 months, or who have undergone revascularization in the prior 2 months
  • Significant allergy or known intolerance to SGLT2 inhibitors or any ingredient in the formulations
  • Participants currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease
  • Any malignancy not considered cured (except basal cell carcinoma of the skin). A participant is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
  • Participants who have participated in studies of an investigational drug or device within 30 days prior to the screening visit
  • Inadequate quality echocardiographic images
  • Unstable coronary syndromes
  • Major surgery (major according to the investigator's assessment) performed within 90 days prior to Visit 1 or scheduled major elective surgery within 90 days after Visit 1.
  • Non-English speaking individuals

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michelle Pitt contact

612-625-6678

henni032@umn.edu

United States1 site, 1 recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55414

    Michelle Pitt, henni032@umn.edu

    Recruiting

Other trials in United States

About this study

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D). In 2015, Zinman et al. published the first large randomized clinical trial (RCT) demonstrating a lower composite CVD outcome in adults with T2D treated with empagliflozin compared to placebo (HR 0.85, 95% CI 0.74-0.99). In the specific case of empagliflozin, the hazard ratio was 0.75 (95% CI 0.65-0.86) for HFrEF 8 and 0.79 (95% CI 0.69-0.90) for HFpEF using a treatment dose of 10mg daily.

The purpose of this placebo-controlled, double-blinded, randomized pilot study is to investigate the effect of empagliflozin on left atrial (LA) function in 80 patients who are at risk for heart failure. Participants will be randomized 1:1 to either intake of a 10mg empagliflozin oral tablet or a matching placebo once daily.

Being tested
empagliflozin, Placebo tablet
Medical subject headings
Hypertension, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • empagliflozinDrug

    intake of a 10mg empagliflozin oral tablet

    At visit 1, after randomization, participants will be provided with bottles containing enough study pills for 3 months duration at 1 tablet daily. Participants will start the study drug on the morning following Visit 1. At the 3 month follow up visit, participants will be provided with enough study pills to complete the remaining 6 months of the study.

  • Placebo tabletDrug

    intake a placebo oral tablet

    At visit 1, after randomization, participants will be provided with bottles containing enough study pills for 3 months duration at 1 tablet daily. Participants will start the study drug on the morning following Visit 1. At the 3 month follow up visit, participants will be provided with enough study pills to complete the remaining 6 months of the study.

Study groups in NCT06507657
Study groupRoleWhat they receive
Experimental groupExperimentalNot described
Receives: Drug: empagliflozin
Placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in LA function

    LA function will be quantified by assessing LA reservoir, conduit, and contractile strain with 2DE at baseline and 9 months.

    Measured: 9 months

Secondary outcomes (16)

  1. change in left ventricular ejection fraction

    Measured: 9 months

  2. change in global longitudinal strain

    Measured: 9 months

  3. change in mass (indexed to body surface area)

    Measured: 9 months

  4. change in E/e' ratio

    Measured: 9 months

  5. change in plasma protein levels: DLK-1 (protein delta homolog 1)

    Measured: 9 months

  6. change in plasma protein levels: GDF15 (growth differentiating factor 15)

    Measured: 9 months

  7. change in plasma protein levels: Spondin-1

    Measured: 9 months

  8. change in plasma protein levels: IGBPF-7

    Measured: 9 months

  9. change in plasma protein levels: THBS-2 (thrombospondin 2)

    Measured: 9 months

  10. change in plasma protein levels: IGFBP-1 (insulin-like binding factor protein 1)

    Measured: 9 months

  11. change in plasma protein levels: FABP-4 (fatty acid-binding protein 4)

    Measured: 9 months

  12. change in plasma protein levels: CCL16 (C-C motif chemokine 16)

    Measured: 9 months

  13. change in cardiovascular disease biomarker C-reactive protein (CRP)

    Measured: 3 months and 9 months

  14. change in cardiovascular disease biomarker Troponin

    Measured: 3 months and 9 months

  15. change in cardiovascular disease biomarker NT-proBNP

    Measured: 3 months and 9 months

  16. changes in blood pressure ration

    Measured: 1, 3 and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study start12 Dec 2024
  3. Primary completion15 Jan 2029 (estimated)
  4. Study completion15 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
placebo-controlled, double-blinded, randomized pilot study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06507657
Sponsor's protocol ID
CV-2023-32230
Status last verified
Oct 2026
First submitted
11 Jul 2024
Last updated
20 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing empagliflozin in people with Hypertension and Cardiovascular Diseases, run by University of Minnesota at 1 site in United States.

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 17 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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 United States. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michelle Pitt (612-625-6678, henni032@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in LA function (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06507657.

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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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