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A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure (SUBCUT-HF I)

Primary Purpose

Heart Failure

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

SQIN-01

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SQIN-01

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Infusion site pain

Measured on a scale of 0 = no pain to 10 = most pain

Any device failures

Serum furosemide concentration

Secondary Outcome Measures

Urine volume

Urine volume (ml) in urine collected 8 hours after start of SQIN-Furosemide infusion

Sodium concentration in urine

Sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion

Presence of local skin reactions

Presence of local skin reactions on examination

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.

Full Information

NCT ID

NCT04846816

First Posted

April 12, 2021

Last Updated

November 16, 2021

Sponsor

SQ Innovation, Inc.

Collaborators

University of Glasgow, NHS Greater Glasgow and Clyde

1. Study Identification

Unique Protocol Identification Number

NCT04846816

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

May 6, 2021 (Actual)

Primary Completion Date

August 13, 2021 (Actual)

Study Completion Date

August 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SQ Innovation, Inc.

Collaborators

University of Glasgow, NHS Greater Glasgow and Clyde

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SQIN-01

Arm Type

Experimental

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

SQIN-01

Intervention Description

Primary Outcome Measure Information:

Title

To investigate the safety, tolerability, efficacy and on-body performance of a novel patch infusor device and novel furosemide formulation combination (SQIN-01).

Description

Safety as determined by treatment emergent adverse events and adverse drug events

Time Frame

24 hours from start of infusion

Title

Infusion site pain

Description

Measured on a scale of 0 = no pain to 10 = most pain

Time Frame

During 5 hour infusion

Title

Any device failures

Description

Any device failures

Time Frame

During 5 hour infusion

Title

Serum furosemide concentration

Description

Serum furosemide concentration

Time Frame

At baseline

Title

Serum furosemide concentration

Description

Serum furosemide concentration

Time Frame

At 60 minutes

Title

Serum furosemide concentration

Description

Serum furosemide concentration

Time Frame

At 240 minutes

Secondary Outcome Measure Information:

Title

Urine volume

Description

Urine volume (ml) in urine collected 8 hours after start of SQIN-Furosemide infusion

Time Frame

8 hours

Title

Sodium concentration in urine

Description

Sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion

Time Frame

8 hours

Title

Presence of local skin reactions

Description

Presence of local skin reactions on examination

Time Frame

After 5 hour infusion

Title

Patient acceptability

Description

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.

Time Frame

After 5 hour infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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) <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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Petrie, MBChB

Organizational Affiliation

University of Glasgow

Official's Role

Study Chair

Facility Information:

Facility Name

Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

to publish

Learn more about this trial

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

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