A Phase 2b, Randomised, Double-Blind, Active-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients with Heart Failure and Chronic Kidney Disease

AstraZeneca AB0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

试验速览

阶段: 2 期
状态: 尚未招募
发起方: AstraZeneca AB

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•Participants are included in the study if any of the following criteria apply
•1. Documented diagnosis of stable symptomatic HF (New York Heart Association class II-III) at screening, and a medical history of typical symptoms and signs of HF in those who are
•currently receiving loop diuretic treatment.
•2. Left ventricular ejection fraction <60% documented by the most recent echocardiogram or cardiac magnetic resonance imaging within the last 12 months prior to screening.
•3. Stable background treatment for HF, hypertension, diabetes mellitus or renal disease according to guidelines.
•4. N-terminal-pro-brain natriuretic peptide (NT proBNP) >=300 pg/mL for participants with sinus rhythm at screening; and NT proBNP >=600 pg/mL for participants with atrial fibrillation/flutter at screening.
•5. The eGFR greater than or equal to 30 and less than or equal to 60 mL/min/1.73square (by CKD- EPI formula) and UACR >=30 mg/g (3 mg/mmol) and <3000 mg/g (300 mg/mmol)
•6. Body mass index less than 40 kg/m square
•7. Serum/plasma K+ level >= 3.5 and < 5.0 mmol/L within 10 days prior to randomization
•8. Serum/ plasma Na+ level within normal reference values within 10 days prior to randomization
•9. Systolic blood pressure should be at protocol defined range at randomization (Visit 3), with no change to antihypertensive treatments in previous 3 weeks.
•10. Male or female of non-childbearing potential.
•11. All participants must follow protocol defined contraceptives procedures.

排除标准

•Participants are excluded from the study if any of the following criteria apply
•1. Primary glomerulopathy, vasculitic renal disease, prior dialysis or unstable rapidly progressing renal disease, autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasm antibody-associated vasculitis
•2. Participants with currently decompensated HF requiring hospitalization for optimization of HF treatment and are not on stable HF therapy at the time of enrollment
•3. HF due to cardiomyopathies
•4. High output HF e.g., due to hyperthyroidism or Pagets disease.
•5. HF due to pericardial disease, congenital heart disease or clinically significant uncorrected primary cardiac valvular disease or planned cardiac valve repair or replacement.
•6. Participants with uncontrolled diabetes mellitus (Glycated hemoglobin >10%).
•7. Participants with Type 1 diabetes mellitus.
•8. Intermittent or persistent 2nd or 3rd degree atrioventricular block, sinus node dysfunction with clinically significant bradycardia or sinus pauses, not treated with a pacemaker.
•9. History of any life-threatening cardiac dysrhythmia or uncontrolled ventricular rate in participants with atrial fibrillation or atrial flutter
•10. Acute coronary syndrome and/or elective/non-elective percutaneous cardiac interventions (within 3 months) prior to randomisation or is planned to undergo any of these procedures during the study.
•11. Any major cardiovascular eg, open chest, coronary artery bypass grafting or valvular repair/replacement or major non-cardiovascular surgery within 3 months prior to randomisation or is planned to undergo any cardiovascular surgery during the study.
•12. Heart transplantation or left ventricular assist device at any time or if these are planned
•13. Kidney or any organ transplantation or if these are planned.
•14. Medical conditions associated with development of hyperkalaemia (Addisons disease).
•15. History or ongoing allergy/hypersensitivity, to sodium-glucose co-transporter-2 inhibitor (SGLT2i e.g., dapagliflozin, empagliflozin).
•16. Stroke, transient ischemic attack, carotid surgery, or carotid angioplasty within previous 3 months prior to randomisation.
•17. Hepatic disease, including hepatitis and/or hepatic impairment (Child-Pugh class A-C), and aspartate aminotransferase or alanine transaminase or total bilirubin should be in protocol defined range at time of screening and/ or within 7 days prior to randomization.
•18. Participants with newly detected pathological laboratory values or an ongoing disease condition
•19. If the participants clinical signs and symptoms consistent with COVID-19, and has been previously hospitalized with COVID-19 infection and did not fully recover their previous health status
•20. Previous randomization in the present study
•21. Prior medical treatment with an mineralocorticoid receptor antagonist where the medication was taken within 90 days prior to screening
•22. Current or prior treatment within 6 months prior to screening with cytotoxic therapy, immunosuppressive therapy, or other immunotherapy

研究者

发起方

AstraZeneca AB

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