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CompletedPhase 1ACTRN12609000998246

Reducing symptoms in acute Acute Heart Failure with a man made vessel dilator peptide

An Exploratory, Single Centre, Open Label, single and Multidose, Safety and Efficacy Study of the Treatment of Acute Decompensated Congestive Heart Failure with Vessel Dilator Peptide by Intravenous Infusion.

Sponsor

Madeleine Pharmaceuticals

Enrollment

36 participants

Start Date

Aug 27, 2010

Study Type

Interventional

Conditions

Acute Decompensated Congestive Heart Failure (ADCHF)

Summary

The purpose of this study is to find out if a man-made heart hormone (“MAD001”) improves the treatment of people diagnosed with acute decompensated congestive heart failure (ADCHF). This substance improves several heart functions, lowers blood pressure and increases salt (sodium) and water removal from the body, when given to animals, healthy humans and persons with chronic congestive heart failure (CHF). The purpose of this study is to determine if this substance also improves heart functionality, and to a lesser extent increases sodium and/or water removal, in persons with ADCHF to improve their condition.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria5

  • Upon diagnosis of ADCHF (New York Heart Association (NYHA) class III - NYHA class IV) with evidence of the following:
  • Signed written informed consent
  • Male and/or female, 18 years or older
  • Women of child bearing potential to test negative to beta-human chorionic gonadotropin (ß-hCG)
  • Systolic dysfunction within the last 12 months (EF <40%) as determined by Trans-Thoracic Echocardiogram (TTE)

Exclusion Criteria13

  • Evidence in the Emergency Department (ED) for Myocardial Infarction (MI) or high risk acute coronary syndrome within past 6 weeks, as determined by creatinine kinase (CK)/creatinine kinase muscle-brain isoenzyme (CK-MB) = 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
  • Evidence in the ED of Acute MI (ST elevation and/or elevation of Troponin T), as determined by Trans-Thoracic electrocardiogram (TTE)
  • Hypotension (Systolic Blood Pressure (SBP)<90 mmHg), cardiogenic shock, volume depletion or any other clinical condition that would contraindicate administration of an Intravenous (IV) agent with potent vasodilatory effects
  • Persistent, uncontrolled hypertension (SBP>180 mm Hg)
  • Presence any Cardiac Magnetic Resonance (CMR) contra-indication (includes Permanent Pacemaker (PPM), cerebral aneurysm clips,
  • Congenital heart defects
  • Cardiac surgery within past 4 weeks
  • Diastolic heart failure (preserved left ventricular function - determined by history or elctrocardiogram (ECG))
  • Severe valvular heart disease: Aortic stenosis (AS), Ideopathic hypertrophic subaortic stenosis (IHSS), Hypertrpohic Obstructive Cardiomyopathy (HOCM), acute Aortic Incompetence (AI) and Mitral Regurgitation (MR)
  • History of cerebrovascular accident (within past 4 weeks)
  • Acute or chronic active infection, including pneumonia and urinary tract infection
  • Significant renal impairment as determined by a creatinine clearance of <60 ml/min
  • Prior participation in any other clinical trial within past 30 days, including present day

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Interventions

Examine whether administration of Vessel Dilator (VSDL) to ADCHF patients in single and multi-dosage regimes induce changes in hemodynamic parameters with renal, natriuretic and diuretic effects as se

Examine whether administration of Vessel Dilator (VSDL) to ADCHF patients in single and multi-dosage regimes induce changes in hemodynamic parameters with renal, natriuretic and diuretic effects as seen in the treatment of CHF patients without serious adverse side-effects (SAE); 1.Single dose of intravenous (IV) VSDL in saline at 50 ng/kg/min for 60 min (n=6) 2.Single dose of IV VSDL in saline at 100 ng/kg/min for 60 min (n=6) 3.Single dose of IV VSDL in saline at 200 ng/kg/min for 60 min (n=6) 4.Standard method of care for the treatment of ADCHF (n=6) 5.Multiple dose of IV VSDL in saline at most appropriate dose (50, 100 or 200 ng/kg/min) for 60 min at 0 h, 12 h, and 24 h (n=6) 6.Multiple dose of IV VSDL in saline at most appropriate dose (50, 100 or 200 ng/kg/min) for 60 min at 0 h, 6 h and 12 h (n=6)

Locations(1)

Australia

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ACTRN12609000998246