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NCT06171100 Clinical Trial

Low-dose Tolvaptan for Inpatient Hyponatraemia.

Hyponatremia Clinical Trial

Official title:
Efficacy and Safety of Low-dose Tolvaptan in Treatment of Inpatient Hyponatraemia.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06171100
Other study ID # GafREC: Endo205
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2024
Est. completion date December 30, 2024

Study information
Verified date March 2024
Source King's College Hospital NHS Trust
Contact Georgios Dimitriadis
Phone 00441698863091
Email g.dimitriadis@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective cohort study to assess the safety and efficacy of low first dose of Tolvaptan and low or standard second dose of Tolvaptan in patients with moderate to severe hyponatraemia associated with SIADH not responding to conservative means of hyponatraemia management. Patients are treated as part of standard clinical care. There is growing evidence that treating patients with SAIDH induced hyponatraemia using a low dose of Tolvaptan with 7.5mg (below licensed lowest 15mg daily dose). This is the largest study to date and seeks to validate the efficacy and safety or this lower than approved dose of Tolvaptan in patietns who only need a first dose but also in patients who need a second low or srandard dose of Tolvaptan.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date December 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - All patients presenting to Accident & Emergency department or seen as inpatients with moderate to severe hyponatraemia (sNa: <125mmol) associated with SIADH and not responding to conservative measures of hyponatraemia management. - Patients of all genders aged 18-90 y.o Exclusion Criteria: - Pregnant women and patients aged < 18y.o - Hyponatraemia not associated with SIADH

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tolvaptan
Oral ingestion of low dose Tolvaptan (7.5mg daily) for management of inpatient hyponatraemia for 1st dose Tolvaptan group. Oral ingestion of low dose Tolvaptan (7.5mg daily) or standard dose Tolvaptan (15mg daily) for 2nd dose Tolvaptan group.

Locations
Country Name City State
United Kingdom King's College Hospital NHS Foundation Trust London

Sponsors (1)
Lead Sponsor Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response to low dose tolvaptan Evaluate the efficacy of tolvaptan 7.5mg daily to improve sodium concentration during inpatient hyponatraemia Within 30 hours from tolvaptan intake
Primary Safety of low dose tolvaptan Evaluate the magnitude of sodium increase after an initial 7.5mg Tolvaptan dose Within 30 hours from tolvaptan intake
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