A Study to Investigate the Safety and Efficacy of a Novel Furosemide Regimen

• Status: Withdrawn
• Trial end date: 2017-03-07
• Target enrollment: 0
• Participant gender: All

Summary

This is a, prospective, single center, open-label, pilot study to evaluate the safety and efficacy of the subcutaneous administration of a novel furosemide formulation. The results of this pilot study will be reviewed to determine the safety of the subcutaneous treatment regimen and to evaluate patient selection criteria for possible at home treatment. The intent is to conduct a future follow on study looking at the feasibility of at home treatment of patients referred to a hospital for treatment of fluid overload.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Todd M Koelling, MD
• Collaborator: scPharmaceuticals, Inc.
• Treatments: Furosemide; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Female or male 18 years or older

2. History of heart failure >90-days

3. Presenting to the University of Michigan Health System because of evidence of fluid overload and recommended for admission or observation unit stay to receive intravenous (IV) furosemide therapy.

4. Estimated excess fluid weight of 10 lbs or more from euvolemic state.

5. Estimated jugular venous pressure (JVP) ≥ 10 cm above the right atrium (RA).

6. Evidence of edema up to mid shin or higher

7. Agreeing to sign informed consent and HIPAA authorization

8. Daily dose of furosemide prescribed ≤ 160 mg, or torsemide ≤ 40 mg or bumetanide ≤ 4 mg.

Exclusion Criteria:

1. Pregnant females or women of child-bearing age who are not willing to use an adequate form of contraception

2. Chronic Obstructive Pulmonary Disease (COPD) moderate or worse: FEV1/FCV ratio <0.7 and FEV1 <60 percent predicted.

3. Rapid atrial fibrillation (AF) (HR >100b/min)

4. Hypoxia (resting O2 saturation <9%)

5. Hypotension (systolic blood pressure (SBP) BP < 90 mmHg)

6. Uncontrolled diabetes mellitus (DM) (admission glucose levels > 300 mg/dL)

7. Advanced renal disease (eGFR < 30mL/min/1.73m2)

8. Hypoalbuminemia (Albumin < 3.0 g/dL)

9. Acute coronary syndrome

10. Serum potassium (K+) <3.5 meq/L or using potassium supplements equivalent to > 80meq/day.

13. On experimental medication or currently participating in cardiovascular research study.

14. Urinary tract abnormality or disorder interfering with urination. 15. Allergy to the active and inactive ingredients of the study medication. 16. Inability to comply with study requirements 17. Dementia 18. Ongoing substance abuse