Study to find out if the drug Vessel Dilator” is absorbed from an infusion under the skin and is safe and tolerated and improves heart function in people diagnosed with stable congestive heart failure and a moderate degree of kidney function loss.

Phase 1

Completed

• Conditions: Stable Congestive Heart Failure; Renal Impairment; Cardiovascular - Other cardiovascular diseases; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12612000576820
• Lead Sponsor: Madeleine Pharmaceuticals Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified