The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure

Study Overview
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Brief Summary
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The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure.

Detailed Description
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There have been many studies done with analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs; however it is not understood how blood pressure changes while using Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of blood pressure.

Official Title
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COX-2 Regulation of Renal Sodium Handling in Blood Pressure Maintenance

Conditions
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Hypertension

Intervention / Treatment
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* Drug: celecoxib (Celebrex)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy men and women Exclusion Criteria: history of heart disease have had heart surgery high blood pressure diabetes cancer any other disease such as kidney or neurological diseases taking medications such as aspirin or medicines for your heart or blood pressure have asthma or are allergic to sulfa drugs body mass index greater than 30 use tobacco pregnant women using oral contraceptives or hormone replacement therapy

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celebrex; Low sodium<br>Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). | Drug: celecoxib (Celebrex)<br>* Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet<br>* Other names: Celebrex;|
| Experimental: Celebrex, High Sodium<br>Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). | Drug: celecoxib (Celebrex)<br>* Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet<br>* Other names: Celebrex;|
| Placebo Comparator: Placebo, Low Sodium<br>Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). | Other: Placebo<br>* Placebo pill taken twice per day on each day of the diet<br>|
| Placebo Comparator: Placebo, High Sodium<br>Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). | Other: Placebo<br>* Placebo pill taken twice per day on each day of the diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Pressure | Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Sodium Excretion | Urine collected over 24 hour period on last day of each different sodium diet | 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Salt sensitivity of Blood Pressure