Study to find out if the drug Vessel Dilator” is absorbed from an injection under the skin and, whether it improves heart function in people diagnosed with chronic heart failure and a moderate degree of kidney function loss.

Phase 1

Completed

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

• Registration Number: ACTRN12611000806965
• Lead Sponsor: Madeleine Pharmaceuticals Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified