Status:
UNKNOWN
Effects of SGLT2 Inhibition on the Mechanisms of Cardiac Damage in the Diabetic Patient With HFpEF
Lead Sponsor:
Hospital General Universitario Gregorio Marañon
Collaborating Sponsors:
University of Navarra
Instituto de Salud Carlos III
Conditions:
Diabetes Mellitus, Type 2
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 typ...
Detailed Description
Double design study including a clinical trial and a nested case-control study. A) Experimental study (clinical trial): Phase IV, prospective, randomized, double-blind placebo-controlled with 12 mont...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04739215
Start Date
January 15 2021
End Date
December 30 2022
Last Update
February 4 2021
Active Locations (1)
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1
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 280007