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

Sponsor
Mariëlle Scheffer
Study ID
NCT04475042
Phase
PHASE2
Status
Unknown

Conditions

  • Heart Failure, Diastolic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 1, 2020
Status verified
Sep 2020
Primary completion
Nov 30, 2021
Completion
May 31, 2022

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A
    Dapagliflozin - washout period - placebo
  • Active Comparator: Group B
    Placebo - washout period - Dapagliflozin

Primary Outcome Measure

Left Ventricular (LV) e' [ Time Frame: 13 weeks ]

Central Contacts

Related Studies