CompletedPhase 2ACTRN12609000508279

A randomised, double-blind, placebo-controlled parallel group, single centre study evaluating neurohumoral, haemodynamic and renal effects of UrocortiN 2 administered In addition to COnventional care compared with placebo administered in addition to standaRd care in subjects with Acute DecompeNsated Heart Failure

Sponsor

Health Research Council of New Zealand

Enrollment

50 participants

Start Date

Oct 20, 2009

Study Type

Interventional

Conditions

Acute Decompensated Heart Failure

Summary

About 1,000 people per year are admitted to Christchurch hospital with Acute Decompensated Heart Failure (ADHF) which is the inability of the heart to pump efficiently, resulting in symptoms like shortness of breath at rest or with minimal activity. The average length of hospital stay for these people is 6 days. Urocortin 2 is a naturally occurring hormone which we have shown to have promising beneficial effects in stable human heart failure. We therefore propose a randomised controlled trial to assess the impact of urocortin 2 on heart hormone activity and kidney function in addition to fluid volume status and shortness of breath symptoms in patients requiring admission to hospital for treatment of ADHF. Once consent is obtained, participants will be given (in addition to the standard treatment) urocortin 2 or placebo as a continuous intravenous infusion (IV) of urocortin 2 or placebo for up to 4 hours. A total of 50 people will be recruited, 25 to each treatment group. Serial assessment of symptoms, physical signs, blood pressure, heart rate, observed jugular venous pressure, renal function (plasma and urine creatinine and urine volume, creatinine, sodium and potassium excretion) and serial plasma neurohormone levels will be carried out over 24 hours in all 50 patients, Within each group, a sub-group of 10 people will undergo right heart catheter studies in addition to a serial blood tests undertaken in all 50 participants. Follow-up observations will include blood pressure, heart rate, renal function and symptom status pre-discharge and clinical events out to 30 days post-discharge

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a hormone called Urocortin 2 for patients hospitalised with acute heart failure who are struggling to breathe even at rest. The treatment is given in addition to standard care, and researchers monitor heart function, kidney function, and symptom improvement.

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

We will compare the effects of standardised conventional treatment (CT) with diuretics and vasodilators in 25 patients to CT plus a once only intravenous infusion (IV) of urocortin 2 (UCN2 at 5ng/kg/min for 4 hours; n=25) in patients recruited within 24 hours of admission with Acute Decompensated Heart Failure (ADHF). Serial assessment of symptoms, physical signs, arterial blood pressure, heart rate, observed jugular venous pressure , plasma and urine creatinine and urine volume, creatinine, sodium and potassium excretion and serial plasma neurohormone levels (urocortins 1 and 2, cardiac natriuretic peptides, renin, angiotensin, aldosterone, catecholamines, endothelin, adrenomedullin , cortisol, urotensin2, Cyclic adenosine monophosphate (cAMP) and Cyclic guanosine monophosphate (cGMP) will be carried out over 24 hours in all 50 patients, with the addition of right heart catheter monitoring of central cardiac haemodynamic status in subgroups of 10 patients in each treatment limb. Follow-up observations will include blood pressure, heart rate, renal function and symptom status pre-discharge and clinical events out to 30 days post-discharge.