None listed
Conditions
Brief summary
The CONTINUUM-HF study aims to evaluate whether vessel dilator peptide VSDL has effects on renal function in participants with acute decompensated congestive heart failure. It shall also evaluate the tolerability and safety of VSDL over 7 day dosing, and assess the pharmacodynamics of VSDL in these participants. The study is a multi-centre, blinded, randomised, placebo-controlled, multi-dose study to be conducted in 8 sites in Australia targeting two target peak concentrations following 1-hour intravenous bolus and daily 12-hour subcutaneous infusions for up to 7 days. The target plasma VSDL concentrations of 5ng/ml and 20ng/ml are chosen to reflect well tolerated and efficacious concentrations in previous trials using this drug. Study subjects shall be reviewed post-IV infusion, at 72 hours, pre-discharge, and at 30 days. A 6 month followup contact will be made via phone call or email. Participants will be given a diary to record any adverse events, changes in medication and visits to doctors.
Interventions
The study medication is Human pro-ANP (31-67).
Participants will be randomised into one of three groups.
For the 1 hour intravenous infusion the two drug groups will receive the same dose of drug 100ng/kg/min.
The subcutaneous infusion dosing of 12 hours on and 12 hours off is for a minimum of three days and a maximum of six days.
Group A-Placebo as described below in the Comparator / control treatment field
Group B- Low dose will receive 450 ug/hr for the first 5 hours and then 135 ug/hr for
The study medication is Human pro-ANP (31-67). Participants will be randomised into one of three groups. For the 1 hour intravenous infusion the two drug groups will receive the same dose of drug 100ng/kg/min. The subcutaneous infusion dosing of 12 hours on and 12 hours off is for a minimum of three days and a maximum of six days. Group A-Placebo as described below in the Comparator / control treatment field Group B- Low dose will receive 450 ug/hr for the first 5 hours and then 135 ug/hr for the next 7 hours. Group C-High dose will receive 1800 ug/hr for the first 5 hours and then 540 ug/hr for the next 7 hours. Close monitoring will occur using adverse event monitoring, vital signs including ECG monitoring,vital signs, urine volume and fluid input monitoring, physical examinations and laboratory assessments. As all study drug is administered in hospital this allows for greater compliance and closer monitoring. Follow up is at 30 days by a clinic visit and a 6 month follow up phone call.
Sponsors
South Australian Health and Medical Research Institute
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who are hospitalised with acute decompensated congestive heart failure and LVEF = 45% and GFR 25-90 mls/min as assessed by Cockcroft and Gault and NTproBNP > 1000pg/mL and Must be able to be hospitalised for a further 72 hours post-IV infusion. Non-pregnant females Signed Informed consent
Exclusion criteria
Acute ST elevation myocardial infarction (STEMI) Pulmonary embolism (PE) Severe valvular heart disease B/P < 90mm Hg. Congenital heart defects Cardiac surgery within 4 weeks Cerebrovascular accident within 4 weeks Presence of hepatic impairment
Outcome results
None listed