ACTRN12623001290684撤回2 期
A Phase 2, Open-label, Single-arm Study to Evaluate the Tolerability, Safety, and Pharmacodynamic Effects of KER-012 in Participants with Chronic Heart Failure.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 45 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Adult participants greater than or equal to 45 to less than or equal to 80 years of age with a diagnosis of either Heart Failure (HF) patients with preserved Ejection Fraction (HFpEF) (Left Ventricular Ejection Fraction (LVEF) greater than or equal to 50%) or Heart Failure patients with reduced Ejection Fraction (HFrEF) (LVEF less than or equal to 40%) with elevated N-terminal pro b-type natriuretic peptide (NT-proBNP) (> 150 pg/mL) despite appropriate and stable HF-directed medical regimen.
- •a. Stable therapy is defined as no change in dose/regimen for at least 30 days prior to Baseline and would be expected to be maintained for the duration of study.
- •b. Participants with HFpEF with defined greater than or equal to Grade 2 diastolic dysfunction.
- •c. Participants with HFpEF with defined body mass index (BMI) of greater than or equal to 20 and less than or equal to 40 kg/m squared.
- •2. Stable New York Heart Association Functional Class (NYHA FC) II to IV symptoms for 30 days prior to enrollment as assessed by the investigator at Screening.
- •3. If participant is taking concomitant medications that may affect clinical HF symptoms (i.e., diuretics, vasodilators, cardiostimulatory or inotropic, cardioinhibitory drugs), the participant must be on a stable dose for at least 30 days prior to Baseline, and the dose would be expected to be maintained during the study.
排除标准
- •1. BMI > 40 kg/m squared.
- •2. HFpEF and HFrEF cohorts:
- •- HFpEF Cohort: Cardiovascular comorbidities, which include any of the following:
- •a. Acute coronary syndrome, acute coronary artery bypass graft, acute percutaneous coronary intervention, or new left bundle branch block within the last 90 days of Visit 1.
- •b. Uncontrolled systemic hypertension as evidenced by seated systolic blood pressure (BP) > 160 mmHg or seated diastolic BP > 100 mmHg at Screening.
- •c. Systemic hypotension as evidenced by a sitting Systolic BP < 90 mmHg at Screening or sitting diastolic blood pressure < 50 mmHg at Screening.
- •d. QT interval corrected by Fridericia (QTcF) recorded on ECG at Screening as follows:
- •i. Male participants with QTcF > 450 msec.
- •ii. Female participants with QTcF > 470 msec.
- •Note: Participants with intraventricular conduction delay defined as QRS > 110 msec will be excluded if QTcF is > 500 msec (both male and female).
- •e. History of known pericardial constriction, sarcoidosis, or amyloid cardiomyopathy.
- •- HFrEF cohort: Cardiovascular comorbidities, which include any of the following:
- •a. Acute coronary syndrome, acute coronary artery bypass graft, acute percutaneous coronary intervention, or new left bundle branch block within the last 90 days of Visit 1.
- •b. Uncontrolled heart rate (> 100 bpm) from atrial fibrillation or atrial flutter.
- •c. History of serious life-threatening or haemodynamically significant arrhythmia.
- •d. Resting heart rate of < 45 bpm or > 115 bpm.
- •e. Acutely decompensated HF that required hospitalisation within 30 days of Visit 1.
- •f. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mmHg or seated diastolic BP > 100 mmHg at Screening after a period of rest.
- •g. Systemic hypotension as evidenced by a sitting Systolic BP < 90 mmHg at Screening or sitting diastolic blood pressure < 50 mmHg at Screening.
- •h. QT interval corrected by Fridericia (QTcF) recorded on ECG at Screening as follows:
- •i. Male participants with QTcF > 450 msec.
- •ii. Female participants with QTcF > 470 msec.
- •Note: Participants with intraventricular conduction delay defined as QRS > 110 msec will be excluded if QTcF is > 500 msec (both male and female) unless a ventricular conduction defect (right bundle branch block; left bundle branch block; or interventricular conduction delay) is present at baseline and not new within 90 days of Visit 1.
- •iii. Personal or family history of Brugada syndrome.
- •iv. Personal or family history of long QT syndrome unless the participant's ECG shows a normal QTc.
- •i. Personal history of sudden cardiac arrest or family history of unexplained sudden cardiac death or arrest.
- •j. Stroke within 90 days of Visit 1.
- •k. Any history of greater than mild mitral or aortic regurgitation valvular disease or greater than mild aortic or mitral stenosis. Severe tricuspid regurgitation may be included unless it is due to primary valvular disease, e.g., from endocarditis, carcinoid, or mechanical destruction.
- •l. Anticipated cardiac valve replacement or repair (mechanical or biomechanical) during the study period.
- •m. History of or anticipated heart transplant or ventricular assist device implantation.
- •n. Implantation of pacemaker or implantable cardioverter defibrillator placement within 30 days of Screening.
- •3. Known history of portal hypertension or chronic liver disease, defined as mild to severe hepatic impairment (Child-Pugh Class A to C).
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