Heart Failure
Conditions
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.
Interventions
COMBINATION_PRODUCTSQIN-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.
Sponsors
SQ Innovation, Inc.
University of Glasgow
NHS Greater Glasgow and Clyde
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Investigate the Safety, Tolerability, Efficacy, and On-body Performance of a Novel Patch Infusor Device and Novel Furosemide Formulation Combination (SQIN-01) | 0-24 hours after infusion start | 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 (TEAEs), (including serious adverse events \[SAEs\]) and adverse drug events (ADEs) (including serious adverse drug events \[SADEs\]). |
| Infusion Site Pain | Baseline, 5 hours after infusion start, 24 hours after infusion start, and maximum pain during 5 hour infusion | Measured on a scale of 0 = no pain to 10 = maximal pain |
| Any Device Failures | During 5 hour infusion | Any device failures (eg, adhesive failure and drug delivery failure) |
| Plasma Furosemide Concentration | At baseline | Plasma furosemide concentration (at 0 min, pre-treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine Volume | 8 hours | Cumulative urine volume (ml) in urine collected over 8 hours from the start of SQIN-Furosemide infusion |
| Sodium Concentration in Urine | 8 hours | Spot sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion |
| Presence of Local Skin Reactions | Baseline, 5 hours post infusion start, and 24 hours post infusion start | Presence of local skin reactions on examination (Erythma/Edema Score: 0 = No skin response; ½ = Questionable or faint, indistinct erythema; 1 = Well-defined erythema; 2 = Erythema with slight to moderate edema; 3 = Vesicles (small blisters) or papules (small, circumscribed elevations); 4 = Bullous (large blister), spreading, or other severe reaction.) |
| Patient Acceptability | 5 hours post infusion start | 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. |
Countries
United Kingdom
Contacts
STUDY_CHAIRMark Petrie, MBChB
University of Glasgow
Participant flow
Recruitment details
This study recruited 20 patients hospitalised with decompensated heart failure recruited from cardiology wards in Queen Elizabeth University Hospital in Glasgow (United Kingdom). Recruitment commenced 6 May 2021 (first subject first visit) and study was completed 13 Aug 2021 (last patient last visit).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 72.9 years STANDARD_DEVIATION 11.63 |
| Body mass index | 30.55 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United Kingdom | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 3 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed