Congestive Heart Failure (CHF) requiring diuretic treatment
Conditions
Interventions
Product Name: SLV320
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: SLV320
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form o
Sponsors
Solvay Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · men without child bearing potential aged = 18 to = 85 years · subjects must have a history of chronic, symptomatic, mild to severe (New York Heart Association Class II-IV) CHF for at least three months requiring treatment with diuretics and with documented systolic dysfunction (Left Ventricular Ejection Fraction = 35% by echo). · Subjects must be on stable doses of their individually optimized medication regimen for at least one week prior to enrollment these medications may include an angiotensin receptor blocker, ACE inhibitor, a beta-blocker and a diuretic · Subjects must have a cardiac index 12 mmHg (at Visit 2) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Subjects with asymptomatic (NYHA Class I) left ventricular dysfunction. · unstable medical condition or heart transplant · The subject's condition do not allow withholding of the diuretics, beta-blockers, ACE inhibitors, nitrates and other vasodilators (if applicable) on Day 1 until after the 12-hour post-dose hemodynamics assessments · Subjects with orthostatic hypotension or symptomatic orthostasis · Subjects with sitting systolic blood pressure 110 bpm on the ECG at Visit 1 · Subjects with heart failure due to primary valvular disease (unless surgically corrected), obstructive cardiomyopathy, pericardial disease, cor pulmonale or congenital heart disease · Hemodynamically significant left ventricular outflow tract obstruction due to severe aortic valve stenosis or sub-aortic stenosis · Severe mitral valve stenosis · Subjects with mechanical heart valve(s) requiring anticoagulants · Subjects with a history of acute myocardial infarction, unstable angina within the last month, or cerebrovascular accident within the last three months · Documented history (within the last month) of sustained or symptomatic ventricular tachycardia (sustained: ³30 seconds) or other arrhythmia which requires treatment with anti-arrhythmic drugs (with the exception of amiodarone), unless an ICD is implanted for this.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the maximum change from baseline on Day 1 in pulmonary capillary wedge pressure (PCWP) over the first 12 hours after dosing of any iv dose of SLV320 in subjects with congestive heart failure (NYHA class II-IV) requiring diuretic treatment compared to placebo. ;Primary end point(s): Maximum change from baseline on Day 1 in pulmonary capillary wedge pressure over the first 12 hours after dosing. ;Secondary Objective: • evaluate the effect on cardiac hemodynamics and safety • evaluate the maximum change from baseline on Day 1 over the first 6 hours after dosing and in addition over the 12 hours after dosing of any dose compared to placebo in systemic vascular resistance (SVR), cardiac output (CO), cardiac index (CI), heart rate, pulmonary systolic, diastolic and artery pressure, systemic systolic, diastolic and arterial pressure, stroke volume index, pulmonary vascular resistance and transpulmonary gradient • evaluate the change in urinary output • evaluate the maximum change from baseline in urinary excretion of sodium, potassium, chloride, creatinine and uric acid • evaluate the change in creatinine clearance • evaluate the SLV320 pharmacokinetic parameters | — |
Countries
Hungary
Outcome results
None listed