HFpEF
Conditions
Interventions
Recruited early HFpEF patients are subjected to a 2x2 crossover design study,
in which patients are randomized to placebo or dapagliflozin 10 mg od for 13
weeks followed by a washout period of 8 wee
Sponsors
OLVG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years at time of screening 2. Symptomatic chronic heart failure patients with diagnosis of heart failure and: • NYHA class II-IV • Preserved systolic LV function, defined by: LVEF >= 50% and LV end-diastolic volume index = 6; 2) HFA-PEFF score >= 5; 3) Paulus criteria 2007 met; 4) Pulmonary capillary wedge pressure > 15 mmHg at rest or > 25 mmHg with exercise assessed with right heart catheterization; 5) ASE/EACVI 2009 recommendations for diastolic dysfunction met. 3. Cardiac MRI T1 derived extracellular volume
Exclusion criteria
Exclusion criteria: 1. Reduced systolic LV function, defined by: LVEF 110 bpm documented by ECG at screening 9. Acute decompensation with necessity to treat with intravenous loop diuretics 10. Systolic blood pressure >=180 mmHg (confirmed with second measurement after 5 minutes). If SBP >150 mmHg and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Change from baseline or placebo in echocardiographically determined E/E*/LVEDV (LV distensibility) after 13 weeks of treatment with dapagliflozin 10 mg od. -Change in mean LV E* after 13 weeks of treatment with dapagliflozin 10mg od. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline or placebo in 6 minute walk distance, Quality of Life (Kansas City Cardiomyopathy Questionnaire), plasma levels of NT-proBNP, collagen, renal function and inflammatory markers and echocardiographically determined left atrial dimensions and function, additional diastolic LV function (E/E*) parameters, LV systolic function and pulmonary artery pressures after 13 weeks of treatment with dapagliflozin 10mg od. Safety criteria: adverse events (AE), AE of special interest (AESI), serious AE, withdrawal from trial medication due to AE, clinically relevant changes in laboratory measurements from baseline, assessment of vital status | — |
Countries
Netherlands
Outcome results
None listed