ACTRN12611000806965已完成1 期
The pharmacokinetics and pharmacodynamics of subcutaneously administered vessel dilator peptide in stable patients with chronic heart failure and moderate renal impairment.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
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
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patients with a history of stable, symptomatic chronic heart failure, with a left ventricular ejection fraction of less than or equal to 45% measured by echocardiogram or nuclear imaging (measurement within 90 days prior to screening).
- •2. Signed Informed Consent.
- •3. Aged 18 years or older.
- •4. Non-pregnant females, as evidenced by serum pregnancy test at screening and negative urine pregnancy test pre dose at Day 1 (for women of child bearing potential only). Women of child bearing potential must agree to use a medically acceptable method of contraception (as determined by the Investigator) for the entire study duration. Females of non child bearing potential are defined as having amenorrhea for at least 2 years prior to study entry or have been surgically sterilized.
- •5. GFR greater than or equal to 25 ml/min/1.73m2 and less than 70 ml/min/1.73 m2(MDRD method).
- •6. Patients on a stable (defined as no alteration to dose/type/frequency within the previous 6 weeks), background therapeutic doses of a beta-blocker, ACE-I or ARB, unless contraindicated and documented as such.
- •7. Patients on a stable (defined as no alteration to dose/type/frequency within the previous 6 weeks) background therapeutic dose of a diuretic and/or aldosterone receptor inhibitor (e.g. spironolactone) unless contraindicated and documented as such.
排除标准
- •1. Evidence of myocardial infarction (MI) or high risk acute coronary syndrome within past 6 weeks, as determined by creatinine kinase (CK)/creatinine kinase a muscle-brain isoenzyme (CK-MB) greater than or equal to 3 times upper limit of normal (as defined by Institute of Medical and Veterinary Science (IMVS) or elevation of troponin T at baseline >0.1.
- •2. Evidence of Acute MI (ST elevation and/or elevation of Troponin T), as determined by a 12-lead ECG.
- •3. Hypotension (Systolic Blood Pressure (SBP)<90 mmHg), cardiogenic shock, volume depletion or any other clinical condition that would contraindicate administration of an agent with potent vasodilatory effects.
- •4. Persistent, uncontrolled hypertension (SBP>180 mm Hg).
- •5. Presence of any Cardiac Magnetic Resonance (CMR) contra-indication (includes Permanent Pacemaker (PPM), cerebral aneurysm clips).
- •6. Congenital heart defects.
- •7. Cardiac surgery within past 4 weeks
- •8. Severe valvular heart disease: aortic stenosis (AS), idiopathic hypertrophic subaortic stenosis (IHSS), hypertrophic obstructive cardiomyopathy (HOCM), acute aortic Incompetence (AI) or mitral regurgitation (MR).
- •9. History of cerebrovascular accident within past 4 weeks.
- •10. Acute or chronic active infection, including pneumonia and urinary tract infection.
- •11. Significant renal impairment as determined by a creatinine clearance of <25 ml/min/1.73 m2 (MDRD).
- •12. Presence of hepatic impairment (defined as ALP, ALT, AST, GGT, Bilirubin >2x ULN) and/or the presence of ascites.
- •13. Other clinically significant findings on any of the screening laboratory tests, as determined by the Investigator, including but not limited to: hyponatremia, hyperkalaemia, acidosis, anaemia (defined as Hb <9g/dL).
- •14. Diagnosis of SIADH, Addison’s disease or renal salt wasting disease.
- •15. Receipt of Investigational Drug within 30 days of screening or current enrolment in a clinical trial.
- •16. History of clinically significant drug or alcohol abuse within the past 12 months – as judged by the Investigator.
- •17. History of renal or cardiac transplantation.
- •18. Insufficient venous access.
- •19. History of current malignancy or malignancy requiring chemotherapy/radiotherapy within 2 years of enrolment.
- •20. History of nephrotic syndrome or clinically significant proteinuria.
- •21. Known history of infection with Hepatitis C, B or HIV.
- •22. Use of NSAIDS.
研究者
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