Subacute decompensated chronic heart failure NYHA Class III-IV
Conditions
Interventions
Product Name: NA
Product Code: ZP120
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: ZP120
Other descriptive name: NA
Con
Sponsors
Zealand Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 18 years or more, 2) A diagnosis of chronic symptomatic congestive heart failure (CHF symptoms and objective evidence of LVD) treated with furosemide and other evidence based treatments for chronic heart failure (NYHA class II-IV), 3) Objective signs of LVD corresponding to a LVEF less than or equal to 45%, determined by echocardiography or radionucleide cardiography within the last year, explaining the heart failure symptoms, 4) Symptoms and objective evidence or signs of cardiac decompensation requiring hospitalization for treatment: a. Worsening heart failure symptoms within the last week (current NYHA class III-IV), b. Evidence or clinical signs of abnormal fluid accumulation: A weight gain of greater than or equal to 2.5 kg within the previous 2 days, and one or more of the following: peripheral edema, ascites, hepatic congestion, or pulmonary congestion, pleural effusion, 5) Fertile women with a negative pregnancy test. Fertile women and male patients must be willing to use an approved method of contraception until the Follow-up Visit on Day 7 6) Ability to understand and willing to sign Informed Consent Form 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: 1) Significant aortic and mitral valve stenosis requiring surgical correction 2) Acute grade 3 mitral valve insufficiency, e.g. corda rupture 3) History of or clinically significant evidence of any severe disease other than heart failure that preclude participation and complicate the evaluation of study results: Hepatic disease (ASAT, ALAT Alkaline Phosphatase, LDH, bilirubin > 3 times ULN or Albumin 12 mmol/l), cancer 4) Unstable angina, cardiogenic shock 5) Myocardial infarction within the last week 6) Pulmonary embolism 7) Cardiac surgery within the last month or acutely required PCI 8) Participation in another study evaluating an experimental compound within the last 30 days 9) Previous treatment with ZP120 10) Consumption of alcohol within 24 hours prior to ZP120 / placebo dosing 11) Inability or unwillingness to provide informed consent 12) Treatment with thiazides 13) BMI outside range of 20-35 kg/m2 (BMI equal to 20 and 35 kg/m2 is accepted) 14) Body weight above 120 kg 15) Any other condition or therapy, which in the opinion of the Principal Investigator would make the patient unsuitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of ZP120 on: Diuresis;Secondary Objective: 1) Glomerular filtration rate, 2)Renal excretion of sodium and potassium, 3) Blood pressure 4) Renal blood flow (non-invasive), 5) Dyspnea severity, 6) Need for rescue medication, 7) Living with Heart Failure Questionnaire (LWHF) 8) Kinetics of ZP120 (end of infusion on each dose level), 9) Safety and tolerability parametres, 10) Assessment of: U-Osmolality, U-AQP2, P-Reinin, P-Angiotensin, P-Aldosteron, P-Vasopressin and P-h-BNP;Primary end point(s): Increase in diuresis | — |
Countries
Denmark
Outcome results
None listed