BridgeMD
Effect of Dapagliflozin on myocardial and renal function following aortic valve stenosis intervention
EU CTIS ID: 2024-514868-11-00
What this study is testing
The overall purpose of this study is to improve treatment of aortic stenosis (AS) patients treated with transcatheter aortic valve replacement (TAVR). The study evaluates the effect of Dapagliflozin on mitochondrial function, myocardial fibrosis, left ventricular hypertrophy, systolic function, renal function, incidence of worsening heart failure and mortality. This will test the potential beneficial effects of Dapagliflozin on myocyte function, interstitial fibrosis, LVH, systolic dysfunction, renal dysfunction, incidence of worsening HF and mortality in AS patients treated with TAVR.
- Phase II and Phase III (Integrated)
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
- 1. Signed informed consent
- 2. Scheduled TAVR for significant symptomatic AS according to current guidelines
- 3. Age < 18 years and < 85 years.
- 4. LVEF >/= 40% and </= 50 % or LVEF > 50% with at least one of the following: - LV GLS < 15% by TTE - LV septum or posterior wall thickness >/= 12mm by TTE or LV mass index >/= 108/131 g/m2 for females/males (mild LVH) - LVEF > 50 % and Nt-proBNP > 600/900 ng/l (sinus rhythm/atrial fibrillation)
- 5. eGFR > 30 mL/min/1.73 m2
You likely can't join if
- 1. Medically treated type 1 or type 2 diabetes mellitus
- 10. Allergy to any substance in the project medicine, both placebo and active medicine.
- 11. Previous renal transplantation.
- 12. Chronic dialysis treatment.
- 2. Ongoing treatment with an SGLT2-inhibitor or intolerance to SGLT2-inhibitors
- 3. Life expectancy < 12 months
See the full eligibility criteria
- 1. Signed informed consent
- 2. Scheduled TAVR for significant symptomatic AS according to current guidelines
- 3. Age < 18 years and < 85 years.
- 4. LVEF >/= 40% and </= 50 % or LVEF > 50% with at least one of the following: - LV GLS < 15% by TTE - LV septum or posterior wall thickness >/= 12mm by TTE or LV mass index >/= 108/131 g/m2 for females/males (mild LVH) - LVEF > 50 % and Nt-proBNP > 600/900 ng/l (sinus rhythm/atrial fibrillation)
- 5. eGFR > 30 mL/min/1.73 m2
- 1. Medically treated type 1 or type 2 diabetes mellitus
- 10. Allergy to any substance in the project medicine, both placebo and active medicine.
- 11. Previous renal transplantation.
- 12. Chronic dialysis treatment.
- 2. Ongoing treatment with an SGLT2-inhibitor or intolerance to SGLT2-inhibitors
- 3. Life expectancy < 12 months
- 4. Symptomatic hypotension or persistent SBP < 100 mmHg
- 5. Contraindications to CMRI
- 6. HF due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis or hypertrophic obstructive cardiomyopathy
- 7. Additional other untreated severe valvular disease
- 8. Liver failure
- 9. Women who are pregnant or plan to be within the study period.**
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, 65+ years, 18-64 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.