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

Heart Failure Clinical Trial

— SUBCUT-HF I  

Official title:

An Open Label, Single Dose Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure: a Phase I Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04846816
• Other study ID #: GN18CA193
• Status: Completed
• Phase: Phase 1
• Start date: May 6, 2021
• Est. completion date: August 13, 2021

Study information

• Verified date: November 2021
• Source: SQ Innovation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 13, 2021
• Est. primary completion date: August 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde	Glasgow

Sponsors (3)

Lead Sponsor	Collaborator
SQ Innovation, Inc.	NHS Greater Glasgow and Clyde, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the safety, tolerability, efficacy and on-body performance of a novel patch infusor device and novel furosemide formulation combination (SQIN-01).	Safety as determined by treatment emergent adverse events and adverse drug events	24 hours from start of infusion
Primary	Infusion site pain	Measured on a scale of 0 = no pain to 10 = most pain	During 5 hour infusion
Primary	Any device failures	Any device failures	During 5 hour infusion
Primary	Serum furosemide concentration	Serum furosemide concentration	At baseline
Primary	Serum furosemide concentration	Serum furosemide concentration	At 60 minutes
Primary	Serum furosemide concentration	Serum furosemide concentration	At 240 minutes
Secondary	Urine volume	Urine volume (ml) in urine collected 8 hours after start of SQIN-Furosemide infusion	8 hours
Secondary	Sodium concentration in urine	Sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion	8 hours
Secondary	Presence of local skin reactions	Presence of local skin reactions on examination	After 5 hour infusion
Secondary	Patient acceptability	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.	After 5 hour infusion