A Phase 2 Multi-Centre Study to Characterise the Pharmacodynamics of Vessel Dilator Peptide (VSDL) in Patients with Acute Decompensated Congestive Heart Failure to be assessed by effects on renal function.
Phase 2
- Conditions
- Acute Decompensated Congestive Heart FailureCardiovascular - Other cardiovascular diseases
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 65
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in creatinine clearance from baseline up to 72 hours from the single 1 hour intravenous VSDL infusion assessed by measuring the serum creatinine in the blood and then using the Cockcroft-Gault formula to formulate the GFR at baseline and then at 72 hours[72 hours post the intravenous dose.]
- Secondary Outcome Measures
Name Time Method