Hypertension study: Empagliflozin
Official title Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
ClinicalTrials.gov ID: NCT06507657
What this study is testing
What is empagliflozin?
This is an investigational oral tablet being studied to see if it helps with high blood pressure in people at risk for heart failure. It is designed to block a protein in the kidneys that reabsorbs sugar, causing the body to remove extra sugar through urine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine whether empagliflozin improves left atrial function compared with placebo in people who are at risk for heart failure.
- Who it's for
- Adults who are at risk for heart failure, about 80 participants in total.
- What's involved
- Participants will take a 10‑mg empagliflozin tablet or a matching placebo once daily. They will have regular clinic visits and tests to measure left atrial function.
- Time commitment
- The study will last for the treatment period, with scheduled visits for medication monitoring and cardiac testing.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.