NL-OMON49053
Recruiting
Phase 2
Stratified Treatment to Ameliorate Diastolic left ventricular stIffness in eArly Heart Failure with preserved Ejection Fraction (STADIA-HFpEF) A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF. - STADIA-HFpEF study
OLVG0 sites26 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- HFpEF
- Sponsor
- OLVG
- Enrollment
- 26
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \>\= 18 years at time of screening
- •2\. Symptomatic chronic heart failure patients with diagnosis of heart failure
- •NYHA class II\-IV
- •Preserved systolic LV function, defined by: LVEF \>\= 50% and LV end\-diastolic
- •volume index \<97 ml/m2
- •Evidence of diastolic LV dysfunction and at least 1 out of the 5 following
- •additional criteria:
- •1\) H2FPEF score \>\= 6;
- •2\) HFA\-PEFF score \>\= 5;
- •3\) Paulus criteria 2007 met;
Exclusion Criteria
- •1\. Reduced systolic LV function, defined by: LVEF \<50% measured at any time
- •point in the history of the patient
- •2\. Obstructive coronary artery disease with evidence of ischemia
- •3\. Myocardial infarction (i.e., increase in cardiac enzymes in combination with
- •symptoms of ischemia or newly developed ischemic ECG changes), coronary artery
- •bypass graft surgery or other major cardiovascular surgery, stroke or TIA in
- •past 90 days prior to screening visit
- •4\. More than mild valve stenosis
- •5\. More than moderate aortic and/or mitral valve regurgitation
- •6\. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis),
Outcomes
Primary Outcomes
Not specified
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Unknown
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