Clinical trial NCT03959930: Transdermal Fluid Removal in Fluid Overload
Official title: Transdermal Fluid Removal in Fluid Overload
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Odema
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: British Heart Foundation
name: Medical Research Council
First posted: 2019-05-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal.

Detailed description: Fluid overload is distressing and is particularly prevalent in patients with vital organ dysfunction such as in kidney and heart disease. Due to the patient's inability to remove excess wastes and water, these accumulate in their body fluid compartments. Such excess fluid and toxins have to be removed with high dose diuretics (water tablets or injections) or by frequent dialysis. Treatment with diuretics is effective initially in some patients but is fraught with risks and side effects. The retained fluid and wastes are mainly lodged within the extracellular compartment (interstitial or tissue fluid) and exert deleterious effects on cell functions. Much of this excess fluid collects relatively superficially within the skin, especially in the lower extremities or other dependent body parts as oedema.

The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal.

Principal aim of the research: To investigate whether the TFR device can remove clinically viable or relevant volumes of fluid transdermally in advanced heart failure and other patients with significant oedema. "Clinically viable" volume is defined as the removal of 200ml or more of fluid in a session of up to 10 hours (or 0.43 ml/h per 1cm2 of the skin area treated with microneedles).

Eligibility criteria: Inclusion Criteria:

* Participants aged \>18 years
* Diagnosis of heart failure
* Presence of visible oedema

Exclusion Criteria:

* Inability to give consent
* Patient on warfarin or simthrome (acecoumarol) with International Normalised Ratio (INR) \>3 or other bleeding disorders
* Extensive skin disease, infected or broken skin over intended study area
* Pregnancy NB: Patients with pacemakers or implantable cardiac devices (ICD) may be recruited but will not have bioimpedance measurements

Primary outcomes:
measure: Overall Success rate (volume): the % of patients that achieved the removal >200ml of fluid transdermally in a session.
timeFrame: 12 months
Secondary outcomes:
measure: Overall Success rate (flow rate): % of patients in whom >0.43 ml/h per 1cm2 was removed using either 550µm or 850µm microneedles
timeFrame: 12 months
measure: Success rate with short (550µm) and long (850 µm) microneedles respectively: % of patients in each category in whom >200ml or >0.43 ml/h per 1cm2 was removed
timeFrame: 12 months
measure: Microneedle insertion depth/force ratio: Mean (+SD) of microneedle skin insertion depth/insertion force used per microneedle type (550 µm and 850µm)
timeFrame: 12 months
measure: Proportion of successfully penetration of microneedles per array: Tertile bands of successfully penetrated microneedle per array
timeFrame: 12 months
measure: Incidence (%) of adverse rate per event and for all events
timeFrame: 12 months
measure: Tolerability of TFR: N (%) in categories: "Well, very well, poorly or very poorly" tolerated.
timeFrame: 12 months
measure: Characteristics of patients with successful versus unsuccessful TFR (e.g. demographics, extent of oedema, bioimpedance volumes, serum albumin)
timeFrame: 12 months
measure: Impact of the fluid extraction on routine activities including mobility, comfort, recovery experience: N (%) patients reporting "improved, no change or worsening" of each parameter.
timeFrame: 12 months
measure: Patient' views on impact, usability and potential of the TFR device: N (%) patients reporting positive, negative or neutral in each category.
timeFrame: 12 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
References: