Comparative study of the effect of oral or subcutaneous furosemide on diuresis in patients with heart failure

• Conditions: Fluid overload in heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-002546-49-NL
• Lead Sponsor: scPharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-22
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Written informed consent must be obtained before any assessment is performed
Male and female subjects =18 years of age, with body weight <120 kg and body mass index (BMI) <30 kg/m2
Participant must have been on oral furosemide 40 mg qd or bid for a period 90 days
History of chronic heart failure with presence of moderate symptoms of decompensation. DHF is defined as presence of signs and symptoms of heart failure, like dyspnea at rest or minimal exertion, pulmonary congestion and/or peripheral edema at the time of presentation in combination with elevated levels on natriuretic peptides (NT-proBNP > 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

Contraindication to furosemide
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
Systolic BP (SBP) < 90 mm Hg
Temperature > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>To assess the effects on signs and symptoms of heart failure (e.g. dyspnea)<br>To investigate if furosemide induced diuresis correlates with changes in bioimpedance parameters<br>To investigate if pretreatment bioimpedance measurements predict diuretic response to furosemide<br>To investigate injection site reactions and discomfort during sc administration<br>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<br>8 hour following start of administration

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Natriuresis;Timepoint(s) of evaluation of this end point: 6 hour following start of administration<br>8 hour following start of administration