ACTRN12612000576820CompletedPhase 1
The pharmacokinetics, tolerability and safety of vessel dilator (VSDL) peptide following subcutaneous infusion to steady state in patients with stable congestive heart failure and moderate renal impairment.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1.A history of stable, symptomatic CHF, with a left ventricular ejection fraction (LVEF) of less than or equal to 45% measured with transthoracic echocardiogram (TTE) or gated blood pool scan, performed 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.Brain Natriuretic Peptide (BNP) greater than or equal to 100 pg/mL
- •6.GFR greater than or equal to 25 mL/min and less than 70 mL/min as calculated by Cockroft Gault formula
Exclusion Criteria
- •1.Evidence of myocardial infarction (MI) or high risk acute coronary syndrome within past 6 weeks, as evidenced by ST elevation by a 12-lead ECG or by creatine phosphokinase 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 >0.1
- •2.Evidence of Acute MI (ST elevation and/or elevation of Troponin-T), as determined by a 12-lead ECG and plasma troponin levels
- •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.Congenital heart defects
- •6.Cardiac surgery within past 4 weeks
- •7.Severe valvular heart disease: aortic stenosis (AS), hypertrophic obstructive cardiomyopathy (HOCM), aortic incompetence (AI) or mitral regurgitation (MR)
- •8.Alteration to dose/type/frequency of background therapeutic doses of a beta-blocker, ACE-I or ARB within the previous six weeks.
- •9.Alteration to dose/type/frequency of background therapeutic doses of a diuretic and/or aldosterone receptor inhibitor (e.g. spironolactone) within the previous six weeks.
- •10.History of cerebrovascular accident within past 4 weeks
- •11.Acute or chronic active infection, including pneumonia and urinary tract infection
- •12.Significant renal impairment as determined by a GFR of <25 ml/min as calculated with Cockroft Gault formula. All participants will be required to demonstrate a stable GFR pre-dose on Day 1 to ensure that GFR has not fallen below the protocol specified criteria for ongoing enrolment into the study.
- •13.Presence of hepatic impairment (defined as ALP, ALT, AST, GGT, Bilirubin >2x ULN) and/or the presence of ascites
- •14.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)
- •15.Diagnosis of syndrome of inappropriate antidiuretic hormone hypersecretion (SIADH), Addison’s disease or renal salt wasting disease
- •16.Receipt of Investigational Drug within 30 days of screening or current enrollment in a clinical trial
- •17.History of clinically significant drug or alcohol abuse within the past 12 months – as judged by the Investigator
- •18.History of renal or cardiac transplantation
- •19.Insufficient venous access
- •20.History of current malignancy or malignancy requiring chemotherapy/radiotherapy within 2 years of enrolment (including any current or past history of prostatic malignancy)
- •21.History of nephrotic syndrome or clinically significant proteinuria (>1g/24hr)
- •22.Known history of infection with Hepatitis C, B or Human Immunodeficiency Virus
- •23.Use of NSAIDS within 24 hours, or five half-lives, whichever is longer, of start of infusion
- •24.History of chronic migraine (defined as >15 episodes per month)
- •25.Inability to conform to the conditions of the protocol.
Investigators
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