Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2025-12-24 @ 6:57 PM
NCT ID:
NCT06507657
Eligibility Criteria:
Inclusion 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
Exclusion Criteria:
* 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: 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT06507657
Study Brief:
Protocol Section:
NCT06507657