Glomerular Injury of Preeclampsia

NCT00275158 | Completed

• 2 other identifiers: DK-52876 (completed)DK-52876
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Pre-eclampsia complicates 7 - 10% of pregnancies and constitutes a leading cause of fetal growth retardation and premature birth, as well as infant and maternal morbidity and mortality. The kidney is the primary site of injury resulting in high blood pressure, loss of protein into the urine and decreased kidney function. The release of vasoconstrictors over vasodilators from an abnormal placenta may underlie pre-eclampsia. Nitric Oxide (NO) is an important vasodilator that is thought to play an important role in the kidneys ability to accommodate to a healthy pregnancy. Normal pregnancy in the rat is accompanied by increased production of NO and its second messenger cGMP. There is a parallel increase in renal expression of constitutive nitric oxide synthase (NOS), the enzyme that generates NO from arginine. In the pregnant rat, an infusion of NG-nitro-L-arginine methyl ester (L-NAME), an exogenous inhibitor of NOS, has been shown to replicate some of the hemodynamic features of the syndrome of pre-eclampsia. In a recent animal study, L-arginine supplementation reversed the adverse effects of L-NAME on pregnancy by attenuating the high blood pressure and by significantly decreasing protein loss in the urine. To date, studies of the use of L-arginine supplementation to treat women with pre-eclampsia have been small or uncontrolled and have only assessed blood pressure as a primary outcome measure. We report a single center, randomized, placebo-controlled trial of L-arginine supplementation for the treatment of pre-eclampsia, in which precise physiological techniques have been utilized to assess kidney dysfunction in addition to blood pressure.

Conditions

Pre-Eclampsia

Keywords

Pre-Eclampsia; Glomerular Filtration Rate (GFR); Inulin clearance; Hypertension; L-Arginine; Nitric Oxide; cGMP; Endothelin; ADMA

Outcome Measures

Primary Outcomes (3)

• Mean Arterial Pressure

• Glomerular Filtration Rate (inulin clearance)

• Proteinuria (albumin to creatinine ratio)

Secondary Outcomes (2)

• Vasoactive hormone levels - Nitric Oxide, Endothelin, cGMP, ADMA

• Neonatal Outcomes

Interventions

L-Arginine Supplementation DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Women selected for the study were diagnosed with pre-eclampsia in the second half of pregnancy.
• i.) an elevation of blood pressure to levels in excess of 140 systolic over 90 diastolic ii.) proteinuria determined by a urine dipstick value ≥ 2+, or quantitated at ≥ 0.5 g either per gram of creatinine or in a 24 hour urine collection.

You may not qualify if:

• Women with a history of underlying renal disease defined as a pre-pregnancy azotemia (serum creatinine ≥ 1.2 mg/dl) or proteinuria

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bryan D Myers, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: January 1, 2000
• Study Completion: December 1, 2003
• Last Updated: January 14, 2010

Record last verified: 2010-01

Locations

US (1)