2024-516597-30-00招募中2 期
The FibroCAN study. Mineralocorticoid receptor antagonist treatment for diabetic cardiovascular autonomic neuropathy
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The CART E/I ratio (by the Vagustm device)
研究概览
简要总结
The objective of this study is to investigate the disease modifying effect of finerenone on early CAN in a 78-week doubled blinded, randomized placebo-controlled multi-centre trial of people with type 2 diabetes and early-stage CAN. Treatment effects on neuropathy measures, levels of fibrosis and inflammation and heart function will be explored.
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
- •Given informed consent
- •Type 2 diabetes defined by WHO criteria
- •Aged 40 ≥ at inclusion
- •Pathological E/I ratio (Mean value of three measures)
排除标准
- •No CAN (no abnormal CARTs)
- •Server forms of respiratory disease including asthma and COPD
- •Any nondiabetic cause of neuropathy
- •All female subjects of childbearing potential (WOCBP) must have a negative result of a highly sensitive urine HCG (pregnancy test) performed at screening. Subjects of childbearing potential must agree to use a highly effective form of contraception throughout the duration of the study (list of definition on WOCBP and accepted contraception in appendix A).
- •Not able to read, write and/or understand Danish
- •Breastfeeding
- •Nephropathy requiring dialysis
- •Beta-blocker-use
- •Hyperkalemia at sceening visit (serum potassium >4.8 mmol/l)
- •eGFR < 25 ml/min/1.73m2
- •serum potassium > 4.8 mmol/l (at randomization)
- •have received chemotherapeutic treatment within last 12 months
- •Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit
- •Lactose intolerance
- •Grapefruit consumption that cannot be discontinued during the study period
- •Treament with moderate to strong CYP3A4-induceres (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St John’s Wort or efavirenz) which cannot be discontinued 4 weeks prior to screening visit
- •Severe hepatic impairment
- •inability to complete study protocol, assessed to investigator
- •Definite CAN (more than one abnormal CART)
- •HbA1C >100 mmol/mol
- •Treatment with potassium-sparing diuretics (amiloride) or MRAs e.g., spironolactone or eplerenone which cannot be discontinued 4 weeks prior to screening visit. The patient’s primary physician, who is not involved in this study, will determine if discontinuation is possible
- •Atrial fibrillation/flutter
- •Congestive heart failure (NYHA class 3-4)
- •History of cardiac arrhythmia
结局指标
主要结局
The CART E/I ratio (by the Vagustm device)
The CART E/I ratio (by the Vagustm device)
次要结局
- Cardiovascular reflex tests: R/S ratio, Valsalva manoeuvre (CARTs)
- HRV indices (SDNN, RMSSD, Low and high-frequency power) (by the Vagustm device)
- Fibrosis markers (serum PRO-C6 and C3M assessed by ELISA)
- Fibrosis markers in skin biopsies (Pro-C6 and C3M by immunostaining (Only week 0, 36, 78)
研究者
Peter Rossing
Scientific
Steno Diabetes Center Copenhagen
研究点 (2)
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