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Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients

Recruitingn/aAges 18 Years - anyAllGrigore T. Popa University of Medicine and Pharmaโ€ฆ
NCT07237451 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

The main aim of this study is to holistically assess the cardiovascular and renal outcomes in HFpEF CKD patients with and without SGLT2 inhibition, with focus on the endothelial disfunction, MACE and mortality using clinical evaluation, flow mediated dilatation, carotid-femoral pulse wave velocity, intima-media thickness, echocardiographic parameters, NMR metabolomics and a series of novel biomarkers.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * age\>18 years; * ejection fraction \> 40; * patients with CKD stage 3-4 (eGFR between 15-60 mL/min/1.73m2), with iSGLT2 recommendation, diabetic and non-diabetic; * age, sex and CKD stage 3 and 4 matched patients without iSGLT2 administration. Exclusion Criteria: * eGFR\< 15 mL/min/1.73m2 or patients undergoing dialysis; * presence of congenital heart disease, decompensated cirrhosis, pregnancy and active malignancies; * coronary artery disease (including those with a history of acute coronary syndrome, angina pectoris, or prior coronary angiography or CT angiography demonstrating significant coronary artery lesions); * cardiac medical devices, namely metallic joint prostheses, cardiac stent or pacemakers; * active systemic infections (due to interference with biomarkers that can give false rise values).
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What it tests

  • Arterial stiffness
  • Echocardiography
  • Biomarkers determination
  • NMR metabolomics and uremic toxins mapping
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Where

1 site
Dr. C.I. Parhon Hospital in Iasi
Iaศ™i, Romania
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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