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

Phase 1

Completed

• Conditions: Acute Decompensated Congestive Heart Failure (ADCHF); Cardiovascular - Other cardiovascular diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12609000998246
• Lead Sponsor: Madeleine Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

1. 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
2. Evidence in the ED of Acute MI (ST elevation and/or elevation of Troponin T), as determined by Trans-Thoracic electrocardiogram (TTE)
3. 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
4. Persistent, uncontrolled hypertension (SBP>180 mm Hg)
5. Presence 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. Diastolic heart failure (preserved left ventricular function - determined by history or elctrocardiogram (ECG))
9.Severe valvular heart disease: Aortic stenosis (AS), Ideopathic hypertrophic subaortic stenosis (IHSS), Hypertrpohic Obstructive Cardiomyopathy (HOCM), acute Aortic Incompetence (AI) and Mitral Regurgitation (MR)
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 creatinine clearance of <60 ml/min
13.Prior participation in any other clinical trial within past 30 days, including present day

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in cardiac index (CI)<br>This will be measured via a pulmonary artery cather (Swan Ganz catheter) and trans-thoracic echocardiogram (TTE)[at 24 hours following administration of drug];Change in pulmonary capillary wedge pressure (PCWP)<br>This will be measure via a pulmonary artery cather (Swan Ganz catheter)[at 24 hours following administration of drug]