Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction. 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.

Mariëlle Scheffer1 site in 1 country26 target enrollmentJuly 1, 2020

ConditionsHeart Failure, Diastolic

InterventionsDapagliflozin Placebo

Overview

Phase: Phase 2
Intervention: Dapagliflozin
Conditions: Heart Failure, Diastolic
Sponsor: Mariëlle Scheffer
Enrollment: 26
Locations: 1
Primary Endpoint: Left Ventricular (LV) e'
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2020

End Date

May 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Mariëlle Scheffer

Responsible Party

Sponsor Investigator

Principal Investigator

Mariëlle Scheffer

Principal Investigator

Onze Lieve Vrouwe Gasthuis

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years at time of screening
•Symptomatic chronic heart failure patients with diagnosis of heart failure and:
•NYHA class II-IV
•Preserved systolic Left Ventricular (LV) function, defined by: LV Ejection Fraction (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:
•H2FPEF score ≥ 6;
•HFA-PEFF score ≥ 5;
•Pulmonary capillary wedge pressure \> 15 mmHg at rest or \> 25 mmHg with exercise assessed with right heart catheterization;
•Cardiac MRI T1 derived extracellular volume \<29% at screening
•Oral diuretics, if prescribed to the patient according to local guidelines and at the discretion of the investigator, should be stable for at least 1 week prior to baseline visit

Exclusion Criteria

•Reduced systolic LV function (LVEF \< 50%), measured at any time point in the history of the patient
•Obstructive coronary artery disease with evidence of ischemia
•Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to screening visit
•More than mild valve stenosis
•More than moderate aortic and/or mitral valve regurgitation
•Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. hemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (stress cardiomyopathy), hypertrophic (obstructive) cardiomyopathy or known pericardial constriction
•History of mitral valve repair or replacement
•Atrial fibrillation or atrial flutter with a resting heart rate \> 110 bpm at screening
•Acute decompensation that requires intravenous loop diuretics
•Systolic blood pressure ≥ 180 mmHg. If SBP \> 150 mmHg and \< 180 mmHg, the patient should be receiving at least 3 antihypertensive drugs at screening or baseline visit