Phase 2
N=38
Dapagliflozin (DAPA) Effects in HFpEF
Heart Failure With Preserved Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT04730947 ↗Enrolled (actual)
38
Serious AEs
10.5%
Results posted
Oct 2023
Primary outcome: Primary: Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise — -6.6; -0.4 mmHg — p=0.027
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dapagliflozin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise |
-6.6; -0.4 | 0.027 sig |
| PRIMARY Pulmonary Capillary Wedge Pressure (PCWP) at Rest |
-2.5; 1.1 | 0.029 sig |
| SECONDARY Change in Body Weight |
-3.7; -0.2 | 0.006 sig |
| SECONDARY Change in Total Blood Volume |
-118; 142 | 0.12 |
| SECONDARY Change in Plasma Volume |
-170; 115 | 0.014 sig |
| SECONDARY Change in Right Atrial (RA) Pressure at Maximal Exercise |
-3.4; 0.8 | 0.011 sig |
| SECONDARY Change in Right Atrial (RA) Pressure at Rest |
-1.6; 0.3 | 0.088 |
| SECONDARY Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise |
-5.2; 0.7 | 0.024 sig |
| SECONDARY Change in Mean Pulmonary Arterial Pressure (PA) at Rest |
-1.8; 1.1 | 0.136 |
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.
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 ( mild stenosis, > moderate regurgitation),
- Severe kidney disease (estimated glomerular filtration rate (GFR) < 30) or liver disease,
Data sourced from ClinicalTrials.gov (NCT04730947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.