A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure

Phase 1

Completed

• Conditions: Heart Failure
• Interventions: Combination Product: SQIN-01

• Registration Number: NCT04846816
• Lead Sponsor: SQ Innovation, Inc.

Brief 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.

Detailed Description

The investigational product consists of a novel higher concentration (30mg/mL) furosemide formulation developed for subcutaneous administration and a novel patch pump placed on the abdominal skin. This trial will investigate the on body performance of novel patch pump delivering the novel formulation. Study parameters include pharmacokinetic measurements and diuretic response following subcutaneous administration of 80mg of furosemide solution in 2.7mL in patients with heart failure (HF). Recruitment will be restricted to 1 site with a recruitment target of 20 patients. All trial related activities will be conducted in an inpatient environment.

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-15
• Study Start: 2021-05-06
• Primary Completion: 2021-08-13
• Study Completion: 2021-08-13
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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) <90 mmHg
  • Pregnancy or breastfeeding
  • Left sided valve disease with planned surgery or percutaneous intervention
  • Type 1 myocardial infarction during index hospitalisation (type 2 myocardial infarctions are allowed)(5)
  • Any surgical or medical condition which prevents patient from ambulation during the infusion
  • Renal impairment, defined as eGFR < 30 mL/min/1.73 m2 at screening.
  • Patient on active cardiac transplant waiting list
  • Potassium <3.0 mmol/L
  • Potassium >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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SQIN-01	SQIN-01	The drug and device combination is called SQIN-01. SQIN-01 is a combination of SQIN-Infusor and SQIN-Furosemide Investigational pump (SQIN-Infusor, medical device) intended for subcutaneous infusion of investigational product, SQINFurosemide.

Primary Outcome Measures

Name	Time	Method
Infusion site pain	During 5 hour infusion	Measured on a scale of 0 = no pain to 10 = most pain
Any device failures	During 5 hour infusion	Any device failures
Serum furosemide concentration	At 240 minutes	Serum furosemide concentration
To investigate the safety, tolerability, efficacy and on-body performance of a novel patch infusor device and novel furosemide formulation combination (SQIN-01).	24 hours from start of infusion	Safety as determined by treatment emergent adverse events and adverse drug events

Secondary Outcome Measures

Name	Time	Method
Patient acceptability	After 5 hour infusion	Patient acceptability using System Usability Scale - from 0 to 100 with a lower number correlating to poor usability and a higher number correlating to better usability by patients.
Presence of local skin reactions	After 5 hour infusion	Presence of local skin reactions on examination
Urine volume	8 hours	Urine volume (ml) in urine collected 8 hours after start of SQIN-Furosemide infusion
Sodium concentration in urine	8 hours	Sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion

Trial Locations

Locations (1)

Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde; 🇬🇧 Glasgow, United Kingdom