Using Empagliflozin to Improve Blood Flow in Heart Failure Patients
The Effect of Empagliflozin on Peripheral Microvascular Dysfunction in Heart Failure With
This study is testing if the medication Empagliflozin can improve blood flow and quality of life for people with heart failure who have preserved ejection fraction.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT06046612 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Empagliflozin on peripheral microvascular function in patients diagnosed with heart failure with preserved ejection fraction (HFpEF). Participants will take Empagliflozin as part of their regular treatment and will undergo assessments before and after three months of treatment, including quality of life questionnaires, blood tests, and non-invasive blood flow measurements using laser speckle contrast analysis. The study aims to identify clinical factors that correlate with microvascular dysfunction to better target treatment for those who may benefit most from Empagliflozin.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with heart failure with preserved ejection fraction who are starting treatment with Empagliflozin.
Not a fit: Patients under 18 years of age or those with severe kidney or liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with heart failure and enhance their quality of life.
How similar studies have performed: Previous studies have shown positive outcomes with Empagliflozin in heart failure patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HFpEF diagnosis according to the ESC 2021 Guidelines for the diagnosis and treatment of acute and chronic heart failure Symptoms and signs of HF LVEF ≥ 50% (on any imaging modality) Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/ raised LV filling pressures, including raised natriuretic peptides (table 1) OR invasively measured pulmonary capillary wedge pressure (PCWP) of \>15 mmHg (at rest) or ≥25 mmHg (with exercise) or left ventricular end diastolic pressure ≥ 16 mmhg (at rest). * Ability to understand and speak the Dutch language * Treatment with empagliflozin 10mg once daily is planned to be started by the treating physician * Signed informed consent Exclusion Criteria: * Unable or unwilling to sign informed consent * Under 18 years of age * Contra-indication to the use of empagliflozin Severe kidney disease (Glomerular filtration rate\< 20 ml/min) Severe liver insufficiency Recent (\<12 months) or planned major surgery (Including coronary artery bypass grafting, cardiac valve replacement) Severe acute disease (\< 12 months) (Including acute coronary syndrome, TIA/CVA) Pregnancy * Use of empagliflozin or other SGLT-2 inhibitor at baseline * Known hypersensitivity to empagliflozin, acetylcholine, sodium nitroprusside or insulin * Insulin dependent patients (Fasting conditions cause a risk of ketoacidosis in these patients). * Subjects currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study. * Any condition that interferes with the correct execution of the LASCA measurements (patient is unable to keep arms motionless during the measurements, any condition that does not allow disposables to be attached to the forearm skin) * Any other reason that makes it undesirable for patient to use empagliflozin according to the researcher / treating physician
Where this trial is running
Maastricht, Limburg
- Maastricht University Hospital — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Study coordinator: Sanne GJ Mourmans, Drs.
- Email: sanne.mourmans@mumc.nl
- Phone: +31433871612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.