Evaluation of the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction (CAMEO-DAPA): A Phase II, Prospective, Double-Blind Study
Overview
- Phase
- Phase 2
- Intervention
- Dapagliflozin
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Sponsor
- Mayo Clinic
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Barry Borlaug
Principal Investigator
Mayo Clinic
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
- •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,
Arms & Interventions
Dapagliflozin Group
Subjects with HFpEF will take the study drug dapagliflozin daily
Intervention: Dapagliflozin
Placebo Group
Subjects with HFpEF will take a placebo daily
Intervention: Placebo
Outcomes
Primary Outcomes
Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
Time Frame: 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
Time Frame: 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 Outcomes
- Change in Total Blood Volume(Baseline, 24 weeks)
- Change in Plasma Volume(Baseline, 24 weeks)
- Change in Right Atrial (RA) Pressure at Maximal Exercise(Baseline, 24 weeks)
- Change in Body Weight(Baseline, 24 weeks)
- Change in Right Atrial (RA) Pressure at Rest(Baseline, 24 weeks)
- Change in Mean Pulmonary Arterial Pressure (PA) at Rest(Baseline, 24 weeks)
- Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise(Baseline, 24 weeks)