Low-dose Tolvaptan for Inpatient Hyponatraemia.

Last updated: March 7, 2024
Sponsor: King's College Hospital NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Treatment

Tolvaptan

Clinical Study ID

NCT06171100
GafREC: Endo205
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients presenting to Accident & Emergency department or seen as inpatients withmoderate to severe hyponatraemia (sNa: <125mmol) associated with SIADH and notresponding to conservative measures of hyponatraemia management.
  • Patients of all genders aged 18-90 y.o

Exclusion

Exclusion Criteria:

  • Pregnant women and patients aged < 18y.o
  • Hyponatraemia not associated with SIADH

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: Tolvaptan
Phase:
Study Start date:
March 15, 2024
Estimated Completion Date:
December 30, 2024

Connect with a study center

  • King's College Hospital NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

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