Heart Failure Clinical Trial

Dapagliflozin (DAPA) Effects in HFpEF

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 ejection fraction (HFpEF) and improve cardiac metabolism.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

Type I diabetes.
Type II diabetes with poor control (HgbA1C ≥ 10%).
Recent hospitalization (< 30 days) or revasculariation (< 90 days).
Primary cardiomyopathy (such as amyloid).
Constrictive pericarditis.
Dyspea due to primary lung disease or myoardial 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 GFR < 30) or liver disease,

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT04730947

Recruitment Status:

Completed

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT04730947

Recruitment Status:

Completed

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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