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Salt Loading and Thiazide Intervention Study (SALTI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yen Pei Christy Chang, University of Maryland
ClinicalTrials.gov Identifier:
NCT00896389
First received: May 7, 2009
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  Purpose

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, plays a central role in kidney sodium transport, the investigators propose a pharmacogenetics study to examine the relationships between STK39 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 by predicting patients most likely to effectively control their blood pressure by adopting salt-reducing diet and taking thiazide diuretics.


Condition Intervention Phase
Hypertension
 Procedure: Salt loading
Drug: Hydrochlorothiazide (HCTZ)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Relationship Between STK39 Genotypes, Salt Sensitivity, Thiazide Diuretics-induced Blood Pressure Response

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Blood pressure changes [ Time Frame: Four hours for the salt loading intervention and 7 days for the hydrochlorothiazide intervention ] [ Designated as safety issue: No ]
  • Fasting glucose level [ Time Frame: 7 days for the hydrochlorothiazide intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma HCTZ concentration [ Time Frame: 7 days for the hydrochlorothiazide intervention ] [ Designated as safety issue: No ]
  • Serum potassium level [ Time Frame: 7 days for the hydrochlorothiazide intervention ] [ Designated as safety issue: Yes ]
  • Other changes in blood chemistry, such as in serum Na, Cl, and blood urea nitrogen [ Time Frame: Four hours for the salt loading intervention and 7 days for the hydrochlorothiazide intervention ] [ Designated as safety issue: No ]
  • Changes in urine chemistry, such as pH, protein, creatinine [ Time Frame: Two hours for the salt loading intervention and 7 days for the hydrochlorothiazide intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All
All subject will undergo salt loading and hydrochlorothiazide interventions. Pre-and post interventions phenotypes will be analyzed.
 Procedure: Salt loading
We will perform salt loading intervention, a routinely prescribed diagnostic test to determine if patients have hypoaldosteronism, on 120 subjects. After overnight fasting, subjects will arrive at the Amish Research clinics. After taking height, weight, BP, and body temperature (intervention will not proceed if fever is detected), the patient will be in supine position, have IV line inserted and fitted for an automatic BP monitor. BP will be taken every 5 minutes until the last 3 SBP readings are within 3 mmHg. Once the BP has "equilibrated" 2 L of 0.9% NaCl saline will be intravenously infused over 4 hours. BP will be taken every 15 minutes during this procedure and for 2 hours after the intervention. Blood and urine samples will be collected from all subjects pre- and post-infusion.
Drug: Hydrochlorothiazide (HCTZ)
We will perform short-term HCTZ intervention on the same 120 subjects.The subjects will arrive to the ARC after overnight fasting (day 1), have 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. The subjects will return to ARC on day 8 and have height, weight, and BP measured again. Blood and urine will be collected on both day 1 and day 8. After a minimum 6-week wash-out period, the subjects will come back to the ARC and repeat the 7-day diuretics 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.
Other Names:
  • Hydrochlorothiazide
  • HCTZ
  • Apo-Hydro
  • Aquazide H
  • Dichlotride
  • Hydrodiuril
  • HydroSaluric
  • Microzide
  • Esidrex
  • Oretic.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896389

Locations
United States, Pennsylvania
Amish Research Clinics
Lancaster, Pennsylvania, United States, 17607
Sponsors and Collaborators
University of Maryland
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Yen Pei C. Chang, Ph.D. University of Maryland, Baltimore County
  More Information

Publications:

Responsible Party: Yen Pei Christy Chang, Associate professor, University of Maryland
ClinicalTrials.gov Identifier: NCT00896389     History of Changes
Other Study ID Numbers: HP-00040712, R21DK084566
Study First Received: May 7, 2009
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
hypertension
hydrochlorothiazide
HCTZ
 salt sensitivity
Salt sensitivity
Hydrochlorothiazide induced hyperglycemia

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Sodium Chloride Symporter Inhibitors
Hydrochlorothiazide
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013