Fluid overload in heart failure
Conditions
Interventions
Trade Name: Lasix
Product Name: furosemide
Pharmaceutical Form: Tablet
INN or Proposed INN: FUROSEMIDE
CAS Number: 54-31-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
scPharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent must be obtained before any assessment is performed Male and female subjects =18 years of age, with body weight 300 pg/mL) In the opinion of the investigator, able to participate in the study 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Contraindication to furosemide Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant Systolic BP (SBP) 38°C (oral or equivalent) or sepsis or active infection requiring i.v. anti-microbial treatment Serum sodium < 130 mEq/L and Serum potassium < 3.0 mEq/L Current or planned (throughout the completion of study drug infusion) treatment with any i.v. therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues; or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) History of gastric or intestinal surgery that may affect absorption of oral medication Diagnosed with diabetes mellitus requiring pharmacotherapy Presence or need for urinary catheterization Current or planned ultrafiltration, hemofiltration, or dialysis Impaired renal function defined as an estimated glomerular filtration rate (eGFR) on admission < 15mL/min/1.73 m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation Administration of intravenous radiographic contrast agent within 72 hours prior to screening or acute contrast-induced nephropathy at the time of screening Major surgery within 30 days prior to screening Administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days before screening Inability to follow instructions or comply with procedures Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of 80mg of furosemide delivered by subcutaneous delivery in the abdominal area over 5 hours when compared to oral administration in patients with heart failure with chronic fluid overload.;Secondary Objective: To assess the effects of the furosemide regimen on natriuresis To assess the effects on signs and symptoms of heart failure (e.g. dyspnea) To investigate if furosemide induced diuresis correlates with changes in bioimpedance parameters To investigate if pretreatment bioimpedance measurements predict diuretic response to furosemide To investigate injection site reactions and discomfort during sc administration To obtain plasma samples for pharmacokinetic analyses;Primary end point(s): Diuresis - time to first void, volume of first void, 6-hour diuresis, 8-hour diuresis;Timepoint(s) of evaluation of this end point: 6 hour following start of administration 8 hour following start of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Natriuresis;Timepoint(s) of evaluation of this end point: 6 hour following start of administration 8 hour following start of administration | — |
Countries
Netherlands
Contacts
Public ContactPresident
scPharmaceuticals LLC
Outcome results
None listed