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Clinical Trial Details

Trial ID: L6175
Source ID: NCT04739215
Associated Drug: Dapagliflozin 10 Mg [Farxiga]
Title: Effects of SGLT2 Inhibition on the Mechanisms of Cardiac Damage in the Diabetic Patient With HFpEF
Acronym: CARDIA-STIFF
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Heart Failure With Preserved Ejection Fraction
Interventions: DRUG: Dapagliflozin 10 MG [Farxiga]|DRUG: Placebo
Outcome Measures: Primary: 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., Intrinsic diastolic properties will be analyzed by dynamic pressure-volume loop catheterization., Baseline vs 12 months|Main Structural Objective: Changes in serum levels of procollagen type I C-terminal propertied (PICP, ng/mL), We will measure the changes in serum levels of procollagen type I C-terminal propertied (PICP, ng/mL), a validated biomarker of collagen type I deposition, Baseline vs 12 months | Secondary: Changes in LV stiffness constants (S+ and S-)., LV stiffness constants will be obtained from invasive pressure-volume data analysis., Baseline vs 12 months|Changes in the slope, Emax, of the end-systolic pressure-volume relationship, Emax will be obtained from invasive pressure-volume data analysis., Baseline vs 12 months|Impact of iSGLT2 on myocardial remodeling., Reverse cardiac remodeling will be studied by cardiac magnetic resonance (CMR). CMR studies will be performed on 1.5 T scanners and will include short-axis cine steady-state free-precession images from base to apex, and standard long axis views for the analysis of mass, volume and ventricular function. CMR study will require the administration of a gadolinium contrast medium to study myocardial fibrosis, unless contraindicated., Baseline vs 12 months|Correlation of myocardial remodeling patterns with the intrinsic diastolic properties of chamber VI with systolic function., Results from the pressure-volume analysis and CMR will be assess in common in order to search for association., Baseline vs 12 months|Relative contribution of the intrinsic diastolic properties of the LV and the flow patterns on filling pressures and their modulation under treatment with iSGLT2., Intraventricular flow patterns will be studied by Doppler echocardiography and phase contrast CMR, considering vorticity and blood transport parameters., Baseline vs 12 months|Changes in serum levels of collagen type I C-terminal telopeptide to matrix metalloproteinase ratio (CITP:MMP-1), We will measure the changes in serum levels of collagen type I C-terminal telopeptide to matrix metalloproteinase ratio (CITP:MMP-1), biomarker of the degree of collagen type cross-linking., Baseline vs 12 months|Changes in N-terminal pro brain natriuretic peptide (pg/mL), We will measure the changes in N-terminal pro brain natriuretic peptide (pg/mL), Baseline vs 12 months|Changes in high sensitivity troponin T (pg/mL), We will measure the changes in high sensitivity troponin T (pg/mL), Baseline vs 12 months
Sponsor/Collaborators: Sponsor: Hospital General Universitario Gregorio Marañon | Collaborators: University of Navarra|Instituto de Salud Carlos III|Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 62
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-01-15
Completion Date: 2022-12-30
Results First Posted:
Last Update Posted: 2021-02-04
Locations: Hospital General Universitario Gregorio Maranon, Madrid, 280007, Spain
URL: https://clinicaltrials.gov/show/NCT04739215