SUBCUT-HF I
Research type
Research Study
Full 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
IRAS ID
291473
Contact name
Mark Petrie
Contact email
Sponsor organisation
SQ Innovations
Eudract number
2020-005560-57
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
Research Summary
Heart failure is the most common reason for hospital admission in those over the age of 65 and accounts for 5% of all emergency admissions. Congestion is the primary reason for hospitalisation for heart failure and the majority of patients require multi-day therapy with intravenous diuretics, which can be administered only in the hospital, leading to prolonged admissions. The Heart Failure community has been exploring options to deliver enough diuretic medication without the need for intravenous infusion and long hospital stays.
Furosemide has been in use for over 50 years to make patients get rid of the excess fluid causing their heart issues as urine (diuresis). IV preparations are acidic so SQI have developed a new skin friendly furosemide, called SQIN-Furosemide which can be delivered to subcutaneous tissues with a novel patch pump (SQIN-Infusor).
We have designed SUBCUT-HF I clinical trial to see if the new neutral furosemide given through this new pump under the skin will be tolerated by patients and make them pass urine.
We plan to recruit 20 patients admitted with heart failure who require treatment with intravenous furosemide. Patients who agree to participate in the study will be given a single dose of SQIN-Furosemide infused over 5 hours with SQIN-Infusor placed on their abdomen as in-patients. The safety and tolerability of SQIN-Infusor will be assessed with visual inspection of skin at the device sites and we will ask patients about any pain they experienced and whether they would have been able to use the pump at home themselves (or with a carer). We will also measure the volume balance for patients to see if the SQIN-Furosemide has made them lose fluid. We will look for any side effect of this novel treatment.Summary of Results
Heart failure is a condition where the heart does not pump blood around the body as efficiently as it should. As a result, fluid often gathers in the lungs or legs, causing shortness of breath and/or swollen legs. The treatment for this is often using diuretic tablets, or ‘water tablets’, which make patients pass more urine. If there is a lot of swelling and fluid build up in the body, the tablets are often not powerful enough and patients require treatment in hospital with medication (usually furosemide) given through a drip into a vein in arm (intravenously).
The study started on 6 May 2021 and ended on 13 Aug 2021. The study was conducted in a single site, at the Queen Elizabeth University Hospital, Glasgow, United Kingdom.
In this study we used a new device (a small pump called SQIN-Infusor) and new formulation of the most commonly used ‘water tablet’ medication, called furosemide (SQIN-Furosemide).
This was the first time this drug and device combination was studied in humans. This new small pump was attached to the skin with a sticky dressing, and using a small needle, the new formulation of furosemide was given under the skin (or subcutaneously) instead of through a vein. In this trial we investigated the safety and effectiveness of the new drug and pump together, and whether the treatment can be given without severe side effects.
Twenty (20) patients admitted to hospital with heart failure consented to be a part of this study. They were all admitted to hospital with accumulation of fluid in their bodies and needed treatment with furosemide given through a drip. As part of the trial, they were treated once with the same dose of drug (80mg furosemide) given with the pump. The pump was attached for 5 hours to administer the full dose of medication. The trial team examined the patients, checked their weight, took blood samples and measured how much urine they passed following the new treatment. Patients answered questions to measure pain and their experience with the new pump.
Three (3) patients developed side effects, which included gout, low blood pressure and tiredness. Four (4) patients (25%) developed a local skin reaction which was temporary, presenting as faint redness of skin where the sticky dressing was attached. In one participant, the sticky dressing became loose and the pump detached from their skin before the full treatment was given. The majority of patients (95%) reported no or minimal pain at the time of needle injection. All patients passed more urine than fluid they drank during the study and all lost some weight (which is the treatment aim of using diuretics in this situation), which represented removal of fluid from the body.
This study helps us understand more about the new formulation of furosemide and the new pump and how we can use this to treat future patients. Findings from this study were used to plan a large study in which patients admitted to the hospital with excess of fluid caused by heart failure will be offered to use the new medication and the pump at home, instead of staying in the hospital for treatment given through a drip.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0053
Date of REC Opinion
24 Mar 2021
REC opinion
Favourable Opinion