Dapagliflozin (DAPA) Effects in HFpEF

Phase 2

Completed

Conditions: Heart Failure With Preserved Ejection Fraction

Interventions: Drug: Placebo
Drug: Dapagliflozin

Registration Number: NCT04730947

Lead Sponsor: Mayo Clinic

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 ejection fraction (HFpEF) and improve cardiac metabolism.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

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 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,

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Subjects with HFpEF will take a placebo daily
Dapagliflozin Group	Dapagliflozin	Subjects with HFpEF will take the study drug dapagliflozin daily

Primary Outcome Measures

Name	Time	Method
Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise	Baseline, 24 weeks	Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise.
Pulmonary Capillary Wedge Pressure (PCWP) at Rest	Baseline, 24 weeks	Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during rest.

Secondary Outcome Measures

Name	Time	Method
Change in Total Blood Volume	Baseline, 24 weeks	Total blood volume was assessed using a radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique with the BVA-100 Blood Volume Analyzer. Measured in millimeters (mL)
Change in Plasma Volume	Baseline, 24 weeks	Plasma volume was assessed using a radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique with the BVA-100 Blood Volume Analyzer. Measured in millimeters (mL)
Change in Right Atrial (RA) Pressure at Maximal Exercise	Baseline, 24 weeks	Right Atrial (RA) pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise.
Change in Body Weight	Baseline, 24 weeks	Change in body weight as measured in kilograms (kg)
Change in Right Atrial (RA) Pressure at Rest	Baseline, 24 weeks	Right Atrial (RA) pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during rest.
Change in Mean Pulmonary Arterial Pressure (PA) at Rest	Baseline, 24 weeks	Pulmonary Arterial (PA) pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during rest.
Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise	Baseline, 24 weeks	Pulmonary Arterial (PA) pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise.