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Effects of sodium-glucose cotransporter 2 inhibition on the mechanisms of heart failure with preserved ejection fraction

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520969-51-00
Acronym
FIBHGM-ECNC001-2019
Enrollment
20
Registered
2025-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved ejection fraction

Brief summary

Systolic properties derived from PV curve analysis: Maximum elastance, Diastolic properties derived from PV curve analysis: Relaxation, stiffness, equilibrium volume, elastic recoil

Detailed description

Reverse geometric remodeling variables of the LV: Ventricular volumes and mass measured by cardiac magnetic resonance imaging (MRI), Intraventricular flow patterns based on Doppler echocardiography and phase-contrast MRI: Vorticity parameters and blood transport into the LV; energy exchange between the myocardium and blood, Cardiomyocyte alterations: grade of hypertrophy assessed by morphometry and expression of pro-hypertrophic genes (atrial natriuretic peptide, sarcomeric proteins using real-time RT-PCR and western blot), Interstitial and perivascular fibrosis, Degree of collagen crosslinking, Microvascular alterations, Cardiomyocyte stiffness: Titin, Extracellular matrix: Lysyl-oxidases and hydroxylases, miR-19b, WISPER, and AGEs, Cardiomyocytes: NT-proBNP, high-sensitivity troponin T (TnT)

Interventions

DRUGForxiga 10 mg film-coated tablets

Sponsors

Fundación para la Innovación en Biomedicina, Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Systolic properties derived from PV curve analysis: Maximum elastance, Diastolic properties derived from PV curve analysis: Relaxation, stiffness, equilibrium volume, elastic recoil

Secondary

MeasureTime frame
Reverse geometric remodeling variables of the LV: Ventricular volumes and mass measured by cardiac magnetic resonance imaging (MRI), Intraventricular flow patterns based on Doppler echocardiography and phase-contrast MRI: Vorticity parameters and blood transport into the LV; energy exchange between the myocardium and blood, Cardiomyocyte alterations: grade of hypertrophy assessed by morphometry and expression of pro-hypertrophic genes (atrial natriuretic peptide, sarcomeric proteins using real-time RT-PCR and western blot), Interstitial and perivascular fibrosis, Degree of collagen crosslinking, Microvascular alterations, Cardiomyocyte stiffness: Titin, Extracellular matrix: Lysyl-oxidases and hydroxylases, miR-19b, WISPER, and AGEs, Cardiomyocytes: NT-proBNP, high-sensitivity troponin T (TnT)

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026