Phase 4
N=124
Salt Loading and Thiazide Intervention Study
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00896389 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Blood Pressure Change During Salt Loading — -25.5; 34.6; 23.2; -41.4 mmHg — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Salt loading (Procedure); Hydrochlorothiazide (HCTZ) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure Change During Salt Loading |
-25.5; 34.6; 23.2; -41.4; 62.9; 44.8 | >0.05 |
| PRIMARY Blood Pressure Change After 7 Days of Low Dose (12.5 mg) of HCTZ |
0; 2.0; -1.1; 1.0; -0.7; -4.2 | >0.05 |
| PRIMARY Blood Pressure Change After 7 Days of High Dose (25 mg) of HCTZ |
-2; 0.7; -1.7; 1; -1.3; -4.5 | >0.05 |
| PRIMARY Fasting Glucose Change After 7 Days of Low Dose (12.5 mg) of HCTZ |
9; 2; -0.1 | >0.05 |
| PRIMARY Fasting Glucose Change After 7 Days of High Dose (25mg) of HCTZ |
1.0; 1.0; 2.3 | >0.05 |
| SECONDARY Change in Plasma Aldosterone Level Due to Salt-loading |
-7.5; -1.2; -1.9 | <0.05 sig |
| SECONDARY Change in Plasma Renin Activity Due to Salt-loading |
-0.8; -0.3; -0.4 | >0.05 |
| SECONDARY Change in Plasma Sodium/Potassium Level Due to Salt-loading |
0.3; -0.3; 0.1 | >0.05 |
| SECONDARY Change in Plasma Sodium/Potassium Level During Low Dose of HCTZ |
0; 1.0; 0.6 | >0.05 |
| SECONDARY Change in Plasma Sodium/Potassium Level During High Dose of HCTZ |
1; 0; 2.3 | >0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- Old Order Amish
- Age 18 to 65
- Have systolic blood pressure between 120 and 160 and diastolic blood pressure between 80 and 100
Exclusion Criteria
- History of myocardial infarction, stroke, congestive heart failure, liver disease
- Known cause of secondary hypertension
- Diabetes or Fasting glucose > 100 mg/dL
- Women who are pregnant, on oral contraceptives, or menstruating
- Used hydrochlorothiazide (HCTZ) in the last 8 weeks or known allergy to HCTZ
- Taking non-steroidal anti-inflammatory drugs
- Estimated glomerular filtration rate < 80 mL/m
- Intention to alter dietary habit during the study
- Abuse of alcohol or drug
Data sourced from ClinicalTrials.gov (NCT00896389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.