HypertensionPhase 4SALTINCT00896389

Salt Loading and Thiazide Intervention Study

A Phase 4 study testing Salt loading and Hydrochlorothiazide (HCTZ) in people with Hypertension, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: Salt loading and Hydrochlorothiazide (HCTZ)
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Mar 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Old Order Amish
Age 18 to 65
Have systolic blood pressure between 120 and 160 and diastolic blood pressure between 80 and 100

Who cannot join

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

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Estimated glomerular filtration rate < 80 mL/m
Intention to alter dietary habit during the study
Abuse of alcohol or drug

Trial locations and contacts

1 site in 1 country.

United States1 site

Amish Research Clinics
Lancaster, Pennsylvania, 17607

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions: Hypertension
Being tested: Salt loading, Hydrochlorothiazide (HCTZ)
Keywords: hypertension, hydrochlorothiazide, HCTZ, Salt sensitivity, Hydrochlorothiazide induced hyperglycemia
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Salt loadingProcedure or surgery
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
Also called Hydrochlorothiazide, HCTZ, Apo-Hydro, Aquazide H
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.

Study groups in NCT00896389
Study group	Role	What they receive
Salt-loading and thiazide diuretic (HCTZ)	Other	Salt loading:2 L of 0.9% NaCl. HCTZ:12.5/ 25 mg of HCTZ for 1 week Receives: Procedure: Salt loading; Drug: Hydrochlorothiazide (HCTZ)

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Pressure Change During Salt Loading
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured every 15 minutes for 4 hours.
Blood pressure change is calculated by the trapezoid method. Essentially we use the average of blood pressure at each pair of time points (for example, DBP 30min + DBP 15min)/2 + (DBP 45min + DBP 30min)/2 + … up to 4 hours.) normalized by baseline SBP/DBP.
Measured: Every 15 minutes for 4 hours
Blood Pressure Change After 7 Days of Low Dose (12.5 mg) of HCTZ
Blood pressure change is defined as SBP or DBP average over the 24 hour period, Day 8 subtracts Day 0.
Measured: 24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8
Blood Pressure Change After 7 Days of High Dose (25 mg) of HCTZ
Blood pressure change is defined as SBP or DBP average over the 24 hour period, Day 8 subtracts Day 0.
Measured: 24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8
Fasting Glucose Change After 7 Days of Low Dose (12.5 mg) of HCTZ
Values on Day 8 subtracts Day 0.
Measured: Fasting glucose was measured on day 0 and day 8
Fasting Glucose Change After 7 Days of High Dose (25mg) of HCTZ
Values on Day 8 subtracts Day 0.
Measured: Fasting glucose was measured on day 0 and day 8

Secondary outcomes (5)

Change in Plasma Aldosterone Level Due to Salt-loading
Aldosterone is a hormone that plays a critical role in homeostatic regulation of blood pressure. Change is defined as the post-salt loading values minus the pre-salt loading values
Measured: Aldosterone was measured from blood collected pre and post salt loading
Change in Plasma Renin Activity Due to Salt-loading
Renin is an enzyme that mediates extracellular fluid and regulates blood pressure. Plasma renin activity (PRA) is a measure of the activity of the plasma enzyme renin. PRA is measured in the laboratory by incubating plasma at physiologic temperature in a buffer that facilitates its enzymatic activity. The natural substrate for the enzyme renin is angiotensinogen. Exogenous angiotensinogen is not added to the reaction mixture. This means that, in effect, the PRA results reported are dependent on both renin concentration and the concentration of its substrate in the patient's plasma. Renin cleaves angiotensinogen to produce a decapeptide, angiotensin I, the concentration of which is assayed using liquid chromatography accompanied by tandem mass spectroscopic detection (LC/MS/MS). PRA levels are reported as the amount of angiotensin I generated per unit of time. Change is defined as the post-salt loading values minus the pre-salt loading values
Measured: Renin was measured from blood collected pre and post salt loading
Change in Plasma Sodium/Potassium Level Due to Salt-loading
Na/K ratio is a function of kidney function
Measured: Plasma sodium and potassium measured from blood collected pre and post salt loading
Change in Plasma Sodium/Potassium Level During Low Dose of HCTZ
Na/K ratio is a function of kidney function
Measured: Plasma sodium and potassium measured from blood collected pre and post salt loading
Change in Plasma Sodium/Potassium Level During High Dose of HCTZ
Na/K ratio is a function of kidney function
Measured: Plasma sodium and potassium measured from blood collected pre and post salt loading

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Mar 2013

First posted11 May 2009 (estimated)
Study startOct 2009
Primary completionDec 2012
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00896389
Sponsor's protocol ID: HP-00040712
Other IDs: R21DK084566
Acronym: SALTI
Status last verified: Mar 2022
First submitted: 7 May 2009
Last updated: 25 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wang Y, O'Connell JR, McArdle PF, Wade JB, Dorff SE, Shah SJ, Shi X, Pan L, Rampersaud E, Shen H, Kim JD, Subramanya AR, Steinle NI, Parsa A, Ober CC, Welling PA, Chakravarti A, Weder AB, Cooper RS, Mitchell BD, Shuldiner AR, Chang YP. From the Cover: Whole-genome association study identifies STK39 as a hypertension susceptibility gene. Proc Natl Acad Sci U S A. 2009 Jan 6;106(1):226-31. doi: 10.1073/pnas.0808358106. Epub 2008 Dec 29.
PubMed 19114657
Delpire E, Gagnon KB. SPAK and OSR1: STE20 kinases involved in the regulation of ion homoeostasis and volume control in mammalian cells. Biochem J. 2008 Jan 15;409(2):321-31. doi: 10.1042/BJ20071324.
PubMed 18092945
Chiga M, Rai T, Yang SS, Ohta A, Takizawa T, Sasaki S, Uchida S. Dietary salt regulates the phosphorylation of OSR1/SPAK kinases and the sodium chloride cotransporter through aldosterone. Kidney Int. 2008 Dec;74(11):1403-9. doi: 10.1038/ki.2008.451. Epub 2008 Sep 17.
PubMed 18800028

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Relationship Between Serine Threonine Kinase 39 (STK39) Genotypes, Salt Sensitivity, Thiazide Diuretics-induced Blood Pressure Response
ClinicalTrials.gov ID: NCT00896389
Acronym / sponsor ID: SALTI / HP-00040712
Conditions: Hypertension
Keywords: hypertension, hydrochlorothiazide, HCTZ, Salt sensitivity, Hydrochlorothiazide induced hyperglycemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Oct 2009
Primary completion: Dec 2012 (actual)
Study completion: Mar 2013 (actual)
First posted: 11 May 2009 (estimated)
Results: Posted 31 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Old Order Amish
Age 18 to 65
Have systolic blood pressure between 120 and 160 and diastolic blood pressure between 80 and 100

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Salt loadingSubjects 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.	Procedure or surgery	Salt-loading and thiazide diuretic (HCTZ)
Hydrochlorothiazide (HCTZ)Also: Hydrochlorothiazide, HCTZ, Apo-Hydro, Aquazide HWe 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.	Drug	Salt-loading and thiazide diuretic (HCTZ)

Primary outcome

Blood Pressure Change During Salt Loading
Time frame: Every 15 minutes for 4 hours
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured every 15 minutes for 4 hours. Blood pressure change is calculated by the trapezoid method. Essentially we use the average of blood pressure at each pair of time points (for example, DBP 30min + DBP 15min)/2 + (DBP 45min + DBP 30min)/2 + … up to 4 hours.) normalized by baseline SBP/DBP.
Blood Pressure Change After 7 Days of Low Dose (12.5 mg) of HCTZ
Time frame: 24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8
Blood pressure change is defined as SBP or DBP average over the 24 hour period, Day 8 subtracts Day 0.
Blood Pressure Change After 7 Days of High Dose (25 mg) of HCTZ
Time frame: 24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8
Blood pressure change is defined as SBP or DBP average over the 24 hour period, Day 8 subtracts Day 0.
Fasting Glucose Change After 7 Days of Low Dose (12.5 mg) of HCTZ
Time frame: Fasting glucose was measured on day 0 and day 8
Values on Day 8 subtracts Day 0.
Fasting Glucose Change After 7 Days of High Dose (25mg) of HCTZ
Time frame: Fasting glucose was measured on day 0 and day 8
Values on Day 8 subtracts Day 0.

5 secondary outcomes

Change in Plasma Aldosterone Level Due to Salt-loading
Time frame: Aldosterone was measured from blood collected pre and post salt loading
Change in Plasma Renin Activity Due to Salt-loading
Time frame: Renin was measured from blood collected pre and post salt loading
Change in Plasma Sodium/Potassium Level Due to Salt-loading
Time frame: Plasma sodium and potassium measured from blood collected pre and post salt loading
Change in Plasma Sodium/Potassium Level During Low Dose of HCTZ
Time frame: Plasma sodium and potassium measured from blood collected pre and post salt loading
Change in Plasma Sodium/Potassium Level During High Dose of HCTZ
Time frame: Plasma sodium and potassium measured from blood collected pre and post salt loading

Results and safety

Results posted to the registry on 31 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Salt-loading and Thiazide Diuretics (HCTZ)	124	124

Primary outcome: Blood Pressure Change During Salt Loading

Time frame: Every 15 minutes for 4 hours. Mean (Standard Error). Unit: mmHg

Measure	rs35929607 SNP n = 124
DBP, Genotype GG	-25.5 (4.3)
DBP, Genotype AG	34.6 (11.6)
DBP, Genotype AA	23.2 (7.7)
SBP, Genotype GG	-41.4 (8.4)
SBP, Genotype AG	62.9 (15.7)
SBP, Genotype AA	44.8 (10.6)

rs35929607 SNP: p >0.05, Chi-squared

Population analysed: 124 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, and genotype AA is homozygous for the major allele A.

Primary outcome: Blood Pressure Change After 7 Days of Low Dose (12.5 mg) of HCTZ

Time frame: 24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8. Mean (Standard Error). Unit: mmHg

Measure	rs35929607 SNP n = 28
DBP, Genotype GG	0 (0)
DBP, Genotype AG	2.0 (2.4)
DBP, Genotype AA	-1.1 (1.1)
SBP, Genotype GG	1.0 (0)
SBP, Genotype AG	-0.7 (4.3)
SBP, Genotype AA	-4.2 (1.3)

rs35929607 SNP: p >0.05, Chi-squared

Population analysed: 28 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.

Primary outcome: Blood Pressure Change After 7 Days of High Dose (25 mg) of HCTZ

Time frame: 24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8. Mean (Standard Error). Unit: mmHg

Measure	rs35929607 SNP n = 25
DBP, Genotype GG	-2 (0)
DBP, Genotype AG	0.7 (2.4)
DBP, Genotype AA	-1.7 (1.1)
SBP, Genotype GG	1 (0)
SBP, Genotype AG	-1.3 (4.2)
SBP, Genotype AA	-4.5 (1.3)

rs35929607 SNP: p >0.05, Chi-squared

Population analysed: 25 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.

Primary outcome: Fasting Glucose Change After 7 Days of Low Dose (12.5 mg) of HCTZ

Time frame: Fasting glucose was measured on day 0 and day 8. Mean (Standard Error). Unit: mmHg

Measure	rs35929607 SNP n = 28
Fasting glucose, GG Genotype	9 (0)
Fasting glucose, AG Genotype	2 (2.5)
Fasting glucose, AA Genotype	-0.1 (1.2)

rs35929607 SNP: p >0.05, Chi-squared

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 9 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Salt Loading	0 of 124 (0%)	0 of 124 (0%)	0 of 124
HCTZ	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19114657Wang Y, O'Connell JR, McArdle PF, Wade JB, Dorff SE, Shah SJ, Shi X, Pan L, Rampersaud E, Shen H, Kim JD, Subramanya AR, Steinle NI, Parsa A, Ober CC, Welling PA, Chakravarti A, Weder AB, Cooper RS, Mitchell BD, Shuldiner AR, Chang YP. From the Cover: Whole-genome association study identifies STK39 as a hypertension susceptibility gene. Proc Natl Acad Sci U S A. 2009 Jan 6;106(1):226-31. doi: 10.1073/pnas.0808358106. Epub 2008 Dec 29.
Background: PubMed 18092945Delpire E, Gagnon KB. SPAK and OSR1: STE20 kinases involved in the regulation of ion homoeostasis and volume control in mammalian cells. Biochem J. 2008 Jan 15;409(2):321-31. doi: 10.1042/BJ20071324.
Background: PubMed 18800028Chiga M, Rai T, Yang SS, Ohta A, Takizawa T, Sasaki S, Uchida S. Dietary salt regulates the phosphorylation of OSR1/SPAK kinases and the sodium chloride cotransporter through aldosterone. Kidney Int. 2008 Dec;74(11):1403-9. doi: 10.1038/ki.2008.451. Epub 2008 Sep 17.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yen Pei C. Chang, Ph.D. principal investigator

University of Maryland, Baltimore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Salt loading and Hydrochlorothiazide (HCTZ) in people with Hypertension, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure Change During Salt Loading (time frame: Every 15 minutes for 4 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00896389, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.