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New treatment option for Hypertension
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?
empagliflozin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hypertension.
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
- Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys.
- 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's taking place
- 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 - 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?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.