NCT03682497终止1 期
A Phase I, Open Label, Randomized, Parallel Group, Multicentre Study to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium [sK+] During 28 Days in Patients With HFmrEF or HFpEF and eGFR in the Range of ≥40 and ≤70 mL/Min/1.73m2.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Relative change (%) from baseline in serum potassium
研究概览
简要总结
This is a Phase I, Multicentre study to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium [sK+] during 28 days in Patients with HFmrEF or HFpEF and eGFR in the range of ≥40 and ≤70 mL/min/1.73m2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms and signs consistent with a diagnosis of heart failure (HF)
- •Left ventricular ejection fraction (LVEF) ≥40% by transthoracic echocardiography within the past 12 months
- •Plasma NT-proBNP level ≥125 pg/ml (≥ 600pg/mL if patient has persistent or permanent atrial fibrillation, atrial flutter, or atrial tachycardia)
- •Estimated glomerular filtration rate (eGFR) ≥40 and ≤70ml/min/1.73m2 (by CKD-EPI formula).
- •Baseline serum potassium (sK+) level ≥3.5 and ≤4.8mmol/l.
- •Stable doses of the following medications at baseline for at least 4 weeks prior to randomisation:
- •Angiotensin receptor blocker (ARB) or Angiotensin converting enzyme inhibitor (ACEi) Loop diuretic (up to a 120mg furosemide dose or equivalent
排除标准
- •Patients with documented LVEF <40% at any time (i.e. patients with previously impaired LVEF that has now improved are not permitted).
- •Patients experiencing acute decompensation of heart failure requiring hospital admission or escalation in therapy.
- •Primary cardiomyopathy (e.g. constrictive, restrictive, infiltrative, toxic, hypertrophic, congenital or any primary cardiomyopathy in judgment of Investigator).
- •Hyponatraemia, defined as serum Na+ <135 mmol/L at the time of enrollment.
- •Persistent resting sinus tachycardia >110 bpm or sinus bradycardia <45bpm.
- •Systolic blood pressure (BP) <110mmHg or >180mmHg.
- •Diastolic BP <60 mmHg or >100 mmHg.
- •Patients previously intolerant to MRA (e.g. spironolactone or eplerenone) for any reason.
- •Medical conditions associated with development of hyperkalaemia (e.g. Addison's disease).
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the upper limit of normal (ULN).
- •Patients who have been taking an MR antagonist within 1 month prior to randomization.
研究组 & 干预措施
Spironolactone
Active Comparator
Spironolactone treatment for 28 days
干预措施: Spironolactone (Drug)
AZD9977
Experimental
AZD9977 treatment for 28 days
干预措施: AZD9977 (Drug)
结局指标
主要结局
Relative change (%) from baseline in serum potassium
时间窗: Measurements on day 1, 7, 14, 21 and 28 will be used. The primary comparison between Spironolactone and AZD9977 will be done at day 28.
To compare the effect of AZD9977 with spironolactone on serum potassium (sK+)
次要结局
- Plasma trough concentrations (Ctrough) values of spironolactone and AZD9977(PK samples will be taken (within 60 min prior to dose) at day 1, 7, 14, 21 and 28.)
- Relative change (%) from baseline in serum potassium(Measurements on day 1, 7 and 14 will be used. The primary comparison between Spironolactone and AZD9977 will be done at day 14.)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With DyslipidemiaCardiovascularNCT06238466AstraZeneca98
已完成
1 期
AZD9056 Relative Bioavailability StudyHealthyNCT00908934AstraZeneca24
进行中（未招募）
3 期
AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2Gastric CancerGastroesophageal Junction CancerNCT06346392AstraZeneca594
已完成
1 期
AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19COVID-19NCT04507256AstraZeneca60
已完成
1 期
Effects of AZD1775 on the PK Substrates for CYP3A, CYP2C19, CYP1A2 and on QT Interval in Patients With Advanced CancerSolid TumoursNCT03333824AstraZeneca33