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Salt Loading and Thiazide Intervention Study (SALTI)

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status and phase

Completed
Phase 4

Conditions

Hypertension

Treatments

Drug: Hydrochlorothiazide (HCTZ)
Procedure: Salt loading

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00896389
R21DK084566 (U.S. NIH Grant/Contract)
HP-00040712

Details and patient eligibility

About

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.

Full description

Although hypertension can be easily diagnosed and there are many medications available to treat hypertension, this condition is poorly managed in many patients and is a leading cause of morbidity and mortality worldwide. Because a newly identified hypertension susceptibility gene, STK39 (Serine Threonine Kinase 39), plays a central role in kidney sodium transport, the investigators propose a pharmacogenetics study to examine the relationships between STK39 genotypes and blood pressure responses to salt loading and to thiazide diuretics, hydrochlorothiazide. In addition, STK39 genotypes may also predict those hypertension patients more likely to develop thiazide-induced hyperglycemia. The investigators hypothesize that STK39 genotypes of those single nucleotide polymorphisms (SNPs) that are associated with baseline systolic blood pressure (SBP), diastolic blood pressure (DBP), and hypertension status, will be associated with the outcome of both interventions. Therefore these SNPs can act as markers and contribute to personalized care for hypertension by identifying patients most likely to effectively control their blood pressure by adopting salt-reducing diet versus patients most likely to effectively and safely control their blood pressure by taking thiazide diuretics.

Enrollment

124 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

124 participants in 1 patient group

Salt-loading and thiazide diuretic (HCTZ)
Other group
Description:
Salt loading:2 L of 0.9% NaCl. HCTZ:12.5/ 25 mg of HCTZ for 1 week
Treatment:
Procedure: Salt loading
Drug: Hydrochlorothiazide (HCTZ)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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