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 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT06991257
Eligibility Criteria:
This study is seeking participants who are:
Key Inclusion Criteria include:
* aged 18 years or older.
* \- clinically confirmed to have a diagnosis of heart failure for at least 3 months
* New York Heart Association Class II-IV symptoms
* left ventricular ejection fraction greater than 40%
* Body mass index of 27 kg/m2 or higher
* Kansas City Cardiomyopathy Questionnaire-23 Total Symptom Score \< 85
* Six-minute walking distance greater than 75 meters
Key Exclusion Criteria include:
* Type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body.
* Major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctor.
* History of heart transplantation, or currently listed for a heart transplant, or current planned use of IV vasodilators and/ or inotropes
* Prior intolerance/known hypersensitivity to an SGLT2 inhibitor or contraindication to an SGLT2 inhibitor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06991257
Study Brief:
Protocol Section:
NCT06991257