Suspended

HeMSAExamining Salt Appetite in Haemodialysis Patients Using Functional Magnetic Resonance Imaging

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2020
See protocol details

Summary

Principal SponsorImperial College London
Study ContactEleanor C Sandhu, MBBSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 17, 2020

Actual date on which the first participant was enrolled.

HeMSA Study Phase 2 Up to 20 male, haemodialysis patient who have average %IDWG >4% will be recruited with the target, to proceed to scanning, of 14 patients. Following consent the patients will complete questionnaires (including Salt intake questionnaire - DSQ (Gkza and Davenport, 2017), Edinburgh handedness questionnaire (Oldfield, 1971), MRI checklist) and undergo salt taste preference and threshold testing during a 1 hour session prior to dialysis. The purpose of this visit is to establish the tasteless solution and 2 soup salt concentrations to be used in the salt taste fMRI paradigm, obtain baseline data regarding estimate of salt intake and ensure MRI is safe for this patient. Patients will then attend 2 MRI scanning visits at the Hammersmith Hospital Imperial Campus, one the morning immediately before haemodialysis and one the morning after haemodialysis. Prior to the MRI session, at the Imperial College Clinical Research Facility, the patient will undergo various clinical assessments and have venous blood samples taken. The MRI will be undertaken at the Imperial College Clinical Imaging Facility using a Siemens 3T Verio scanner. During the scan subjects will taste, via a taste delivery system, aliquots of tasteless solution, sucralose, and 2 soup with different concentrations of salt. Solutions will be delivered in a block design. HeMSA Study Phase 3 3 groups (healthy controls, haemodialysis (HD) patients with %IDWG <4%, haemodialysis patients with %IDWG >4% - patients froms phase 2 will contribute to the latter group) Protocol will follow that for HeMSA Phase 2. Healthy controls will also have 2 study visits at a similar period apart to the HD participants.

Official TitleExamining Salt Appetite in Haemodialysis Patients Using Functional Magnetic Resonance Imaging
NCT04011254
Principal SponsorImperial College London
Study ContactEleanor C Sandhu, MBBSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: All participants: * Male * Aged 18-65 years * Non-smoker (ex-smokers allowed) * Right handed (able to use a right handed response button) * Able to tolerate 1 hour MRI scanning session For haemodialysis patients: * Established on haemodialysis for more than 6 months * Urine output \<200ml/24 hours * Average (over the past month) interdialytic weight gain: 1. Main phase 2: \>4 %IDWG 2. Main phase 3: \<4 or \>4 %IDWG Exclusion Criteria: * Type 1 or type 2 diabetes mellitus * Current smoker * Uncontrolled depression (change in use of anti-depressants in last 3 months, or BDI-II score \>28/63) * Neurological disorder (Parkinson's disease, serious cerebrovascular disease, epilepsy, moderate-severe traumatic brain injury, dementia) * Previous bariatric surgery * Inflammatory state (CRP \>20 on routine dialysis blood tests) * Acute infective illness * Significant current or past medical or psychiatric history, or use of medications, that, in the opinion of the Investigators, contraindicates their participation, due to influence on outcome measures. * Patients lacking capacity or unable to consent and non-English language speakers * Contra-indication to MRI imaging e.g. metal insert, pacemaker * Claustrophobia * Patients currently participating in an active CTIMP trial, or within 4 half-lives of last administration of CTIMP product * Serious mental illness (e.g. bipolar disorder, schizophrenia) * Current alcohol or drug dependence

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Imperial College Healthcare NHS Trust

London, United KingdomOpen Imperial College Healthcare NHS Trust in Google Maps
SuspendedOne Study Center
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