Status:
COMPLETED
Dapagliflozin (DAPA) Effects in HFpEF
Lead Sponsor:
Mayo Clinic
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether treatment with Dapagliflozin (DAPA) for 6 months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart failure/preserved eje...
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study specific procedures.
- Male or female.
- Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation.
- EF ≥ 50% + BMI ≥ 30 kg/m\^2
- Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥ 25 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized .
Exclusion
- Type I diabetes.
- Type II diabetes with poor control (HgbA1C ≥ 10%).
- Recent hospitalization (\< 30 days) or revascularization (\< 90 days).
- Primary cardiomyopathy (such as amyloid).
- Constrictive pericarditis.
- Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator.
- Severe anemia (hemoglobin \< 9gm/dl.
- Significant left-sided valvular heart disease (\> mild stenosis, \> moderate regurgitation),
- Severe kidney disease (estimated glomerular filtration rate (GFR) \< 30) or liver disease,
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04730947
Start Date
February 24 2021
End Date
November 17 2022
Last Update
October 12 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905