2025-523743-35-00招募中2 期
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects in Patients with Heart Failure or Cardiovascular Disease and Chronic Kidney Disease (COMPARE-VS)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary endpoint for kidney function is the change in eGFR baseline to 4 and 26 weeks of treatment
研究概览
简要总结
The main objective of this study in patients with heart failure (HF) or cardiovascular disease (CVD) and chronic kidney disease (CKD) is to compare the effects of the ASi, vicadrostat, with the steroidal MRA, spironolactone, on the change in kidney function from baseline to 4 and 26 weeks.
研究设计
- 分配方式
- Randomized
- 主要目的
- Single period, randomized open label
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Provided written and dated informed consent for participation prior to trial admission,
- •Age ≥18 years, female or male
- •Patients with • Heart failure*1 (any LVEF) and eGFR*2 between 25-90 mL/min/1.73m2 OR • Established cardiovascular disease*3 and eGFR between 25-60 mL/min/1.73m2 OR • Established cardiovascular disease and type 2 diabetes and eGFR between 25-90 mL/min/1.73m2
- •Serum potassium ≤ 5.0 mmol
- •Currently treated or eligible for background treatment with Empagliflozin*4
- •Not using a MRA or AS inhibitor in the last 6 months prior to enrollment
- •On stable doses of other guideline directed medical therapies for ≥ 4 weeks prior to enroll-ment
排除标准
- •Inability to understand and sign informed consent
- •Absolute contra-indication for aldosterone antagonist
- •Absolute contra-indication for a SGLT2-inhibitor
- •Heart failure hospitalization, acute coronary syndrome, cardiac surgery, stroke or transient is-chemic attack in the 90 days prior to enrollment
- •Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.
研究组 & 干预措施
OMNIPAQUE 350 mg I/ml.
Auxiliary
干预措施: OMNIPAQUE 350 mg I/ml. (Drug)
Jardiance 10 mg film-coated tablets
Auxiliary
干预措施: Jardiance 10 mg film-coated tablets (Drug)
Spironolacton Accord 25 mg filmomhulde tabletten
Comparator
干预措施: Spironolacton Accord 25 mg filmomhulde tabletten (Drug)
结局指标
主要结局
The primary endpoint for kidney function is the change in eGFR baseline to 4 and 26 weeks of treatment
The primary endpoint for kidney function is the change in eGFR baseline to 4 and 26 weeks of treatment
次要结局
- The endpoints for the renal hemodynamic changes includes measured glomerular filtration rate (mGFR), effective renal plasma flow (ERPF), renal blood flow (RBF), renal vascular resistance (RVR), glomerular pressure (Pglo), afferent vascular resistance (Ra) and efferent vascular resistance (Re) at baseline and after 4 and 26 weeks of treatment
- Endpoints related to plasma and urinary protein profiles are the difference in changes in their profiles between vicadrostat and spironolactone after 4 and 26 weeks of treatment
- Changes in UACR and urinary concentration of sodium, NGAL, and KIM-1 from baseline to 4 and 26 weeks
研究者
Kevin Damman
Scientific
Universitair Medisch Centrum Groningen
研究点 (1)
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