Phase 1
Completed N=20
A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure
Source: ClinicalTrials.gov NCT04846816 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: To Investigate the Safety, Tolerability, Efficacy, and On-body Performance of a Novel Patch Infusor Device and Novel Furosemide Formulation Combination (SQIN-01) — 3; 1 number of events
Summary
This is a single-centre, prospective, open-label, non-comparative clinical trial assessing the on-body performance of an investigational drug delivery device (SQIN-Infusor) in patients hospitalised due to HF.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Investigate the Safety, Tolerability, Efficacy, and On-body Performance of a Novel Patch Infusor Device and Novel Furosemide Formulation Combination (SQIN-01) |
3; 1 | — |
| PRIMARY Infusion Site Pain |
0.5; 0; 0; 0 | — |
| PRIMARY Any Device Failures |
1 | — |
| PRIMARY Plasma Furosemide Concentration |
2971.1 | — |
| SECONDARY Urine Volume |
1700 | — |
| SECONDARY Sodium Concentration in Urine |
96.5 | — |
| SECONDARY Presence of Local Skin Reactions |
0; 0; 0 | — |
| SECONDARY Patient Acceptability |
98.75 | — |
Eligibility Criteria
Inclusion Criteria
- • Written informed consent
- Male or female ≥18 years of age
- Meet ESC criteria for diagnosis of HF(4)
- Inpatient with a primary diagnosis of HF requiring treatment with intravenous furosemide at dose
Exclusion Criteria
- • Unable to consent to inclusion in study due to lack of capacity
- Requiring treatment with intravenous furosemide at dose >200 mg per day as determined by the usual care team
- Current inotropes, vasopressors or intra-aortic balloon pump therapy
- Concomitant use of diuretics in 12 hours preceding administration of study drug with SQIN-Infusor
- Systolic blood pressure (SBP) 6.0 mmol/L
- Sodium <125 mmol/L
- Any contraindications for furosemide administration as per furosemide SmPC
- Any surgical or medical conditions, which in the opinion of the investigator may pose an undue risk to the subject, interfere with participation in the study or which may affect the integrity of the data
Data sourced from ClinicalTrials.gov (NCT04846816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.