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

Phase 4

Not yet recruiting

Conditions: Heart failure with preserved ejection fraction

Registration Number: 2025-520969-51-00

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

Brief Summary: To identify the underlying the biological and biomechanical mechanisms responsible for the cardiovascular benefit demonstrated by iSGLT2 in patients with ICFEP.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Adults of both genders ≥ 18 years

LVEF ≥ 50%

Diagnosis of HFpEF according to clinical criteria, with a history of hospitalization or the need for intravenous diuretic treatment in the previous 6 months, along with evidence of diastolic dysfunction based on echocardiographic criteria

Patients with or without Type II Diabetes Mellitus

Clinically stable condition (> 1 month after hospitalization for HF decompensation or since the last dose of intravenous diuretic treatment)

Clinical indication for cardiac catheterization

Clinical indication to receive de novo treatment with SGLT2 inhibitors

Signed informed consent

Exclusion Criteria

Participation in another clinical trial within 30 days prior to the start of the current study

Pregnant or breastfeeding women

Prior or current treatment with SGLT2 inhibitors

Significant coronary artery disease

Aortic or mitral valvular disease ≥ moderate

Contraindications for dapagliflozin treatment according to the product label (hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption; moderate-to-severe renal insufficiency - CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m² -; severe hepatic insufficiency).

Stroke within 12 months prior to inclusion

Respiratory impairment or the need for home oxygen therapy

Life expectancy of less than 2 years due to any cause

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Reverse geometric remodeling variables of the LV: Ventricular volumes and mass measured by cardiac magnetic resonance imaging (MRI)		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		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)		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		Interstitial and perivascular fibrosis
Degree of collagen crosslinking		Degree of collagen crosslinking
Microvascular alterations		Microvascular alterations
Cardiomyocyte stiffness: Titin		Cardiomyocyte stiffness: Titin
Extracellular matrix: Lysyl-oxidases and hydroxylases, miR-19b, WISPER, and AGEs		Extracellular matrix: Lysyl-oxidases and hydroxylases, miR-19b, WISPER, and AGEs
Cardiomyocytes: NT-proBNP, high-sensitivity troponin T (TnT)		Cardiomyocytes: NT-proBNP, high-sensitivity troponin T (TnT)

Trial Locations

Locations (1): Hospital General Universitario Gregorio Maranon
🇪🇸
Madrid, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Javier Bermejo
Site contact
0034915868279
ucaicec@fibhgm.org