Yükleniyor... / Loading...
Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
Bu çalışma, kalp nakli bekleme listesinde bulunan ileri evre kalp yetmezliği (advanced heart failure) hastalarında Dapagliflozin ilacının böbrek ve kalp üzerindeki akut etkilerini, kan örneğinde suPAR düzeyleri ölçülerek incelemektedir. Çalışmaya; 18-85 yaş arası, NYHA sınıfı 3 ve üzeri, kalp pompalama gücü (LVEF) %35 ve altında olan ve dapagliflozin dahil yönerge temelli tedavi alan hastalar alınmaktadır. Central Hospital, Nancy, France tarafından yürütülen faz uygulanmayan çalışma halen katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 85 years 2. NYHA class ≥3 3. LVEF ≤ 35% 4. On GDMT (including dapagliflozin) based on current heart failure practice guidelines at maximal tolerated dose 5. On waiting list (or on the registration pathway) for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to heart transplant ≥ 6 months or in a pre-transplant pathway. 6. Person affiliated to a social security scheme or beneficiary of such a scheme. 7. A person who has received full information about the organization of the clinical research and has signed an informed consent form. Exclusion Criteria: 1. Priority patient on waiting list for heart transplantation. 2. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy. 3. Inotrope dependent, existence of ongoing mechanical circulatory support 4. Current acute decompensated HF or hospitalization due to decompensated HF \<30 days prior to the enrolment. 5. History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after inclusion. 6. Any recent interventional procedure likely to improve symptoms and heart failure status (coronary revascularization, percutaneous mitral valve intervention, cardiac resynchronization therapy) \< 60 days. 7. Glomerular filtration rate \<25 ml/min/1.73 m2, according to CKD-EPI formula 8. Unstable or rapidly progressing renal disease (autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis). 9. Type 1 diabetes mellitus. 10. Participation in another clinical interventional trial. 11. Any condition other than heart failure that could limit survival to less than 12 months. 12. Pregnant women or breastfeeding mothers 13. vulnerable persons (guardianship, curatorship, safeguard of justice)