CompletedPhase 1ACTRN12611000806965

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.

The pharmacokinetics and pharmacodynamics of subcutaneously administered vessel dilator peptide in stable patients with chronic heart failure and moderate renal impairment.

Sponsor

Madeleine Pharmaceuticals Pty Ltd

Enrollment

8 participants

Start Date

Dec 1, 2011

Study Type

Interventional

Conditions

Renal Impairment Chronic Heart Failure

Summary

The purpose of this study is to find out if the drug “Vessel Dilator” (VSDL) is absorbed from an injection under the skin and whether it improves heart function in people diagnosed with stable chronic heart failure and a moderate degree of kidney function loss. additionally, the study will find out if Vessel Dilator has effects on kidney function.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called Vessel Dilator, given by injection under the skin, is properly absorbed and can improve heart function in people with chronic heart failure and moderate kidney impairment. Participants must be 18 or older with a left ventricular ejection fraction of 45% or less and a kidney filtration rate between 25-70 mL/min.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will receive the Study Drug, Vessel Dilator peptide ('VSDL' or Atrial Natriuretic Peptide (ANP)[31-67]). A lead group of 2 patients will receive a single dose of 250 microgram on day 1 and 5

Patients will receive the Study Drug, Vessel Dilator peptide ('VSDL' or Atrial Natriuretic Peptide (ANP)[31-67]). A lead group of 2 patients will receive a single dose of 250 microgram on day 1 and 500 microgram on Day 2 by subcutaneous bolus. Following review of pharmacokinetic and safety data, a further 6 patients will receive the same doses or up to 2 fold higher if plasma concentrations from the lead group were insufficient to characterise the concentration-time profile.