CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 124 enrolled
Drug / intervention
Hydrochlorothiazide (HCTZ) +1 moredrug
Likely dose
Hydrochlorothiazide (HCTZ) 12.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00896389
NCT00896389Phase 4Completed

The Relationship Between Serine Threonine Kinase 39 (STK39) Genotypes, Salt Sensitivity, Thiazide Diuretics-induced Blood Pressure Response

University of Maryland, Baltimore·interventional·Posted May 11, 2009·Updated Mar 25, 2022

In Brief

A Phase 4 clinical trial evaluating Salt loading and Hydrochlorothiazide (HCTZ) for Hypertension. Completed, enrolled 124 participants across 1 site.

Detailed Summary

The investigators of this study propose to examine the relationships between STK39 (Serine Threonine Kinase 39) genotypes and responses to salt loading and to thiazide diuretics, hydrochlorothiazide. The investigators hypothesize that STK39 genotypes will be associated with the outcome of both interventions and can contribute to personalized care for hypertension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2009
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.1 years ago

Interventions

Salt loadingprocedure

Subjects will arrive at the Amish Research Clinics after overnight fasting. After taking height, weight, BP, and body temperature, subjects will receive 2 liters (L) of 0.9% sodium chloride (NaCl) saline over 4 hours while their blood pressure is monitored every 15 minutes. Blood pressure will be taken every 15 minutes during this procedure. Blood and urine samples will be collected from all subjects pre- and post-infusion.

Hydrochlorothiazide (HCTZ)drug

We will perform short-term HCTZ intervention on the same 120 subjects. After overnight fasting and having their height, weight, and BP measured, subjects are given seven 12.5 mg HCTZ tablets and instructed to take 1 tablet daily for one week. Ambulatory blood pressure will be measured and blood and urine will be collected on both day 1 and day 8. After a minimum 6-week wash-out period, the subjects will repeat the 7-day HCTZ intervention, taking 25 mg of HCTZ instead. Subjects with plasma potassium levels below 3.6 mmol/L on day 8 of 12.5 mg HCTZ will be given a daily supplement of 16 milliequivalents of potassium to prevent harmful loss of potassium while taking HCTZ.