Overview

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

Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital General Universitario Gregorio Marañon
Collaborators:
Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
Instituto de Salud Carlos III
University of Navarra
Treatments:
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Dapagliflozin
Criteria
Inclusion Criteria:

- Diagnosis of DM2 based on the established criteria: HbA1c ≥ 6.5% (48 mmol / mol) and
fasting plasma glucose ≥ 7.0 mmol / L (≥126 mg / dL) or 2-h after overload ≥ 11.1 mmol
/ L ( ≥ 200 mg / dL).

- LVEF ≥ 50%.

- Diagnosis of ICFEP according to clinical criteria, with a hospital admission in the
previous 6 months with demonstration of diastolic dysfunction according to the
echocardiographic criteria.

- Stable clinical situation (> 1 month after hospitalization due to IC decompensation).

- Clinical indication of cardiac catheterization.

- Signature of informed consent.

Exclusion Criteria:

- Previous treatment with iSGLT2.

- Significant coronary disease.

- Aortic or mitral valve disease ≥ moderate (grades 3 or 4/4 for valve regurgitations)

- Contraindications for dapagliflozin treatment according to the data sheet (hereditary
galactose intolerance, Lapp lactase insufficiency or glucose-galactose malabsorption,
moderate-severe renal failure -CrCl <60 ml / min or eGFR <60 ml / min / 1 , 73 m2-,
severe hepatic insufficiency).

The inclusion/exclusion criteria for Descriptive Study will be the same as previously
described without the diagnosis of DM2.