Healthy Clinical Trial
Official title:
The Role of Vasopressin Antagonism on Renal Sodium Handling
Verified date | April 2019 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Vasopressin has primarily been considered to be a water and osmosis regulating hormone that mediates its effects on renal aquaporin channels. Recent data suggest that vasopressin, through its V2 receptor, may also modulate sodium homeostasis. The purpose of this human physiology study was to test whether antagonism of the V2R alters urine sodium excretion in normal healthy volunteers.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 1, 2015 |
Est. primary completion date | September 30, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - - Blood pressure <130/85 mmHg and >100/50 mmHg - Normal laboratory values for (see "Normal Values" table): - Complete blood count - Serum creatinine, sodium, potassium, glucose, liver enzymes - Urinalysis - ECG Exclusion Criteria: - - Alcohol intake >12 oz per week - Tobacco or recreational drug use - History of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months - Any prescription medication or herbal medication use except oral contraceptive or multivitamin - Pregnancy or current breastfeeding - First degree relative with hypertension, diabetes, stroke, renal or cardiac disease |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Otsuka Pharmaceutical Co., Ltd. |
Bankir L, Bichet DG, Bouby N. Vasopressin V2 receptors, ENaC, and sodium reabsorption: a risk factor for hypertension? Am J Physiol Renal Physiol. 2010 Nov;299(5):F917-28. doi: 10.1152/ajprenal.00413.2010. Epub 2010 Sep 8. Review. — View Citation
Blanchard A, Frank M, Wuerzner G, Peyrard S, Bankir L, Jeunemaitre X, Azizi M. Antinatriuretic effect of vasopressin in humans is amiloride sensitive, thus ENaC dependent. Clin J Am Soc Nephrol. 2011 Apr;6(4):753-9. doi: 10.2215/CJN.06540810. Epub 2011 Jan 13. — View Citation
Gheorghiade M, Niazi I, Ouyang J, Czerwiec F, Kambayashi J, Zampino M, Orlandi C; Tolvaptan Investigators. Vasopressin V2-receptor blockade with tolvaptan in patients with chronic heart failure: results from a double-blind, randomized trial. Circulation. 2003 Jun 3;107(21):2690-6. Epub 2003 May 12. — View Citation
Hauptman PJ, Zimmer C, Udelson J, Shoaf SE, Mallikaarjun S, Bramer SL, Orlandi C. Comparison of two doses and dosing regimens of tolvaptan in congestive heart failure. J Cardiovasc Pharmacol. 2005 Nov;46(5):609-14. — View Citation
Stockand JD. Vasopressin regulation of renal sodium excretion. Kidney Int. 2010 Nov;78(9):849-56. doi: 10.1038/ki.2010.276. Epub 2010 Aug 25. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute intravenous saline response | Urine sodium excretion measured in response to saline infusion | 6 hours | |
Secondary | Dietary salt response | Cumulative sodium excretion measured in response to dietary salt loading | 6 days |
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