None listed
Conditions
Brief summary
This will test the safety and efficacy of a new drug called recombinant human Neuregulin-1 in patients with chronic stable heart failure. We hope to establish that recombinant human Neuregulin-1 (rhNRG-1) can be administered safely and that its administration results in improved heart structure and function as measured by cardiac MRI at 12 days and 3 months.
Interventions
Intravenous administration of recombinant Human neuregulin-1 (novel drug). 1.2 mcg/kg/day for 1 day then 2.4 mcg/kg/day intravenously for 10 days.
Sponsors
Peter Macdonald
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed