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Transdermal Fluid Removal in Fluid Overload

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ClinicalTrials.gov Identifier: NCT03959930
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
British Heart Foundation
Medical Research Council
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Heart Failure Odema Device: Transdermal Fluid Removal Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transdermal Fluid Removal in Fluid Overload
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Interventional arm
Total and segmental body fluid volumes (total water, extracellular water and interstitial water) will be measured by Segmental Bioelectrical Impedance Spectroscopy (as per manufacturer instructions of use). Areas with most significant oedema and skin in a suitable condition shall be selected for the TFR application. Moisture Meter shall be used at the selected site to measure the skin water content at 4 depths (0.5mm, 1.5mm, 2.5mm and 5mm).
Device: Transdermal Fluid Removal

The Transdermal Fluid Removal (TFR) device is designed for use on the lower limbs of patients with Chronic Heart Failure and treatment resistant peripheral oedema.

The TFR device is intended to be applied on oedematous skin of eligible patients, for periods of up to 10 hours at a time, to gently remove excess fluid through the skin, over a period of a few days during exacerbations, thereby avoiding hospitalisation for intravenous diuretics.

The TFR device is designed to be used in conjunction with standard Negative Pressure Wound Therapy (NPWT) devices which are currently CE Marked and approved for use in both acute and homecare environment.

Other Name: TFR




Primary Outcome Measures :
  1. Overall Success rate (volume): the % of patients that achieved the removal >200ml of fluid transdermally in a session. [ Time Frame: 12 months ]
    Primary outcome/endpoint


Secondary Outcome Measures :
  1. Overall Success rate (flow rate): % of patients in whom >0.43 ml/h per 1cm2 was removed using either 550µm or 850µm microneedles [ Time Frame: 12 months ]
    % of patients in whom >0.43 ml/h per 1cm2 was removed using either 550µm or 850µm microneedles as reported on CRF

  2. 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 [ Time Frame: 12 months ]
    % of patients in each category in whom >200ml or >0.43 ml/h per 1cm2 was removed as reported on CRF

  3. Microneedle insertion depth/force ratio: Mean (+SD) of microneedle skin insertion depth/insertion force used per microneedle type (550 µm and 850µm) [ Time Frame: 12 months ]
    Mean (+SD) of microneedle skin insertion depth/insertion force used per microneedle type (550 µm and 850µm) as reported on CRF v1.0 and then analysed using appropriate statistics

  4. Proportion of successfully penetration of microneedles per array: Tertile bands of successfully penetrated microneedle per array [ Time Frame: 12 months ]
    Tertile bands of successfully penetrated microneedle per array

  5. Incidence (%) of adverse rate per event and for all events [ Time Frame: 12 months ]
    Adverse event rate: Incidence (%) of adverse rate per event and for all events as reported on AE log v4.0

  6. Tolerability of TFR: N (%) in categories: "Well, very well, poorly or very poorly" tolerated. [ Time Frame: 12 months ]
    N (%) in categories: "Well, very well, poorly or very poorly" tolerated reported on CRF

  7. Characteristics of patients with successful versus unsuccessful TFR (e.g. demographics, extent of oedema, bioimpedance volumes, serum albumin) [ Time Frame: 12 months ]
    N/mean/median (%/SD/IQR) as appropriate for single and multiple characteristics for "successful" and unsuccessful TFR groups as reported on CRF and then analysed using appropriate statistics.

  8. Impact of the fluid extraction on routine activities including mobility, comfort, recovery experience: N (%) patients reporting "improved, no change or worsening" of each parameter. [ Time Frame: 12 months ]
    N (%) patients reporting "improved, no change or worsening" of each parameter as reported on CRF, free text narrative and then analysed using appropriate statistics.

  9. Patient' views on impact, usability and potential of the TFR device: N (%) patients reporting positive, negative or neutral in each category. [ Time Frame: 12 months ]
    N (%) patients reporting positive, negative or neutral in each category, qualitative analysis and then analysed using appropriate statistics.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959930


Contacts
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Contact: Leonard
Contact: Leonard Ebah, PhD 0161 276 4253 leonard.ebah@mft.nhs.uk

Sponsors and Collaborators
Manchester University NHS Foundation Trust
British Heart Foundation
Medical Research Council

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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03959930     History of Changes
Other Study ID Numbers: B00097
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases