Effects of SGLT2 Inhibition on the Mechanisms of Cardiac Damage in the Diabetic Patient With HFpEF

Sponsor
Hospital General Universitario Gregorio Marañon
Study ID
NCT04739215
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The main aim of this study is to identify the underlying mechanisms of Sodium-glucose co-transporter-2 (SGLT2) inhibitors which are associated to better outcomes in patients with Diabetes mellitus type 2 and Heart Failure with preserved Ejection Fraction.

Key Dates

Start date
Jan 15, 2021
Status verified
Feb 2021
Primary completion
Dec 30, 2022
Completion
Dec 30, 2022

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Clinical Trial: Experimental Arm
    Patients with heart failure with preserved ejection fraction and type 2 diabetes mellitus treated with Dapagliflozin (Forxiga) 10 mg, one capsule per day orally.
  • Placebo Comparator: Clinical Trial: Placebo Arm
    Patients with heart failure with preserved ejection fraction and type 2 diabetes mellitus treated with Placebo in a similar pattern.
  • No Intervention: Descriptive Study
    Patients with heart failure with preserved ejection fraction but with no type 2 diabetes mellitus (n=10).

Primary Outcome Measure

Functional Main Objective: Impact of iSGLT2 on LV diastolic properties in terms of the change in LV stiffness constant (S+) at the peak of exercise. [ Time Frame: Baseline vs 12 months ]

Central Contacts

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