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Effects of sodium-glucose cotransporter 2 inhibition on the mechanisms of heart failure with preserved ejection fraction
EU CTIS ID: 2025-520969-51-00
What this study is testing
To identify the underlying the biological and biomechanical mechanisms responsible for the cardiovascular benefit demonstrated by iSGLT2 in patients with ICFEP.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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).
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.