Effects of sodium-glucose cotransporter 2 inhibition on the mechanisms of heart failure with preserved ejection fraction
Key facts
- Where
- Madrid, SpanyolországSee the site
- Phase
- 4. fázis
Where in Spanyolország
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación para la Innovación en Biomedicina
- Trial code
- EU 2025-520969-51-00
- Record updated
- 2025. január 31.
- Original description
To identify the underlying the biological and biomechanical mechanisms responsible for the cardiovascular benefit demonstrated by iSGLT2 in patients with ICFEP.Read full original descriptionShow less
To identify the underlying the biological and biomechanical mechanisms responsible for the cardiovascular benefit demonstrated by iSGLT2 in patients with ICFEP.
Inclusion: 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: Participation in another clinical trial within 30 days prior to the start of the current study; Prior or current treatment with SGLT2 inhibitors; Stroke within 12 months prior to inclusion; Significant coronary artery disease; Aortic or mitral valvular disease ≥ moderate; Respiratory impairment or the need for home oxygen therapy; 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); Pregnant or breastfeeding women; Life expectancy of less than 2 years due to any cause.