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)

SQ Innovation

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Combination Product: SQIN-01

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04846816

GN18CA193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

SQIN-01

Experimental group

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.

Treatment:

Combination Product: SQIN-01