2025-520969-51-00Not yet recruitingPhase 4
Effects of sodium-glucose cotransporter 2 inhibition on the mechanisms of heart failure with preserved ejection fraction
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To identify the underlying the biological and biomechanical mechanisms responsible for the cardiovascular benefit demonstrated by iSGLT2 in patients with ICFEP.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 1 Jun 2023
- Lead sponsor
- Fundación para la Innovación en Biomedicina
- Diseases
- Heart failure
- EU CT number
- 2025-520969-51-00
- EudraCT number
- 2019-002046-20
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure with preserved ejection fraction (LVEF 50% or more) who are clinically stable and are about to start an SGLT2 inhibitor medicine for the first time.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Heart failure with LVEF ≥ 50% and signs of diastolic dysfunction on heart ultrasound. A hospital stay or intravenous diuretic treatment in the previous 6 months. Stable for more than 1 month. People with or without type 2 diabetes can join.
- Earlier treatment
- Must not have had SGLT2 inhibitor treatment before or now. Must have a clinical indication to start a new SGLT2 inhibitor. Must have a clinical indication for cardiac catheterization.
Main reasons for not taking part
- Taking part in another clinical trial in the last 30 days
- Pregnant or breastfeeding women
- Significant coronary artery disease
- Aortic or mitral valve disease of moderate degree or worse
- Stroke in the last 12 months
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Significant coronary artery disease
- Aortic or mitral valvular disease ≥ moderate
- Respiratory impairment or the need for home oxygen therapy
Lab values
- 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).
Other
- Pregnant or breastfeeding women
- Life expectancy of less than 2 years due to any cause
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.