The safety and efficacy of recombinant neuregulin-1 (rhNRG-1) in patients with stable chronic heart failure

Phase 2

Completed

• Conditions: Heart Failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12607000330448
• Lead Sponsor: Peter Macdonald

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Written informed consent. Left ventricular systolic dysfunction (LVEF < 40%) secondary to ischaemic heart disease or cardiomyopathyStable NYHA Class II or III symptomatic heart failurePatients established on ACEI/ARA and beta blocker with stable doses of these medications for the preceding 3 months

Exclusion Criteria

NYHA Class I or IV heart failureAcute myocardial infarction or unstable angina within 3 monthsCoronary artery revascularization or left ventricular remodeling surgery within preceding 3 monthsPatients awaiting coronary artery revascularisation or left ventricular remodeling surgeryImplanted pacemaker or defibrillatorChronic atrial fibrillation or flutterPrimary valvular heart diseaseHypertrophic or restrictive cardiomyopathyClaustrophobiaPregnancy or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Outcome:<br>To assess the safety of rhNRG-1 in patients with stable symptomatic chronic heart failure, as determined by the incidence and severity of adverse clinical events, new electrocardiographic and laboratory abnormalities[For 3 months after intervention commencement];Primary Efficacy Outcome:<br>To assess the effect of rhNRG-1 on left ventricular function and remodeling as determined by change in Left ventricular ejection fraction(LVEF), Left ventricular end diastolic volume (LVEDV) and left ventricular end systolic volume (LVESV), measured by MRI[Measured at 12 days and 3 months post-baseline]

Secondary Outcome Measures

Name	Time	Method
1.To assess the effect of rhNRG-1 on acute haemodynamics (cardiac output, left and right heart filling pressures, pulmonary and systemic blood pressures, and systemic and pulmonary vascular resistance after single and repeated dosing.[With repeated measurements over the first 24 hours and also at day 12 and 3 months];2.To assess the effect of rh-NRG-1 on the following neuro-hormonal and immunological markers in blood: noradrenaline, aldosterone, endothelin-1, nt-proBNP, terminal propeptide of type III procollagen (PIIINP), highly sensitive c-reactive protein (hsCRP),Tumour necosis factor alpha (TNF alpha) and interleukin 6 (IL-6).[];3. To assess the effect of rh-NRG-1 on interstitial myocardial fibrosis as measured by magnetic resonance imaging[At day 12 and 3 months]