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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

NCT ID: NCT04846816

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2021-08-13

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SQIN-01

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Glasgow

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role collaborator

SQ Innovation, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Petrie, MBChB

Role: STUDY_CHAIR

University of Glasgow

Locations

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Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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GN18CA193

Identifier Type: -

Identifier Source: org_study_id