Effects of dapagliflozin inhibition on the mechanisms of cardiac damage in the diabetic patient with HFpEF.-CARDIA-STIFF

Phase 1

• Conditions: Patients with Diabetes mellitus type 2 and Heart Failure with preserved Ejection Fraction.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-002046-20-ES
• Lead Sponsor: Fundación para la Innovación en Biomedicina-FIBMED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-21
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

- Both female and male adults between the ages of 18 and 75.
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified