Other Clinical Trial - Sodium-Endothelial Function-CKD Study

Status Completed

Clinical Trial Summary

Heart disease and stroke, known as cardiovascular disease, are major causes of death in people with chronic kidney disease. Abnormalities of a metabolic pathway called the “L-arginine-nitric oxide” pathway are thought to be particularly important in these people, and previous research in animals has suggested that sodium (salt) affects part of this metabolic pathway. The purpose of our research is to study the effects of sodium intake on the “L-arginine-nitric oxide” pathway, and on blood vessel function, in patients with kidney disease.

Clinical Trial Description

Chronic kidney disease (CKD) is associated with abnormalities of endothelial function (EF) and nitric oxide (NO) synthesis, and it is proposed that the endogenous NO synthase inhibitor asymmetrical dimethylarginine (ADMA) plays a central role. In man ADMA is largely metabolized by dimethylarginine dimethylaminohydrolase (DDAH), with some renal excretion occurring. Sodium inhibits DDAH expression in experimental animals and, given that CKD is frequently characterized by sodium retention, it would be interesting to study the effects of sodium loading on DDAH activity/expression, ADMA levels and EF in CKD patients.

To answer these questions, we have designed a double-blind cross-over study employing Slow Sodium (150 mmol/day) and placebo for seven days in individuals with mild-to-moderate CKD. Changes in the ratio of urinary ADMA to dimethylamine (DMA, an ADMA metabolite) will be used as an marker of DDAH activity/expression. ADMA will be measured by ELISA, DMA by high performance liquid chromatography, and EF by venous occlusion plethysmography.

We propose to test the following hypothesis; that in subjects with mild-to-moderate CKD under conditions of high sodium intake, as compared to low-normal sodium intake:

(i) The ratio [ADMA]urine:[DMA]urine is increased (ii) [ADMA]plasma is increased (iii) Endothelium-dependent vasodilatation is reduced ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00141622
Study type	Interventional
Source	St George's, University of London
Contact
Status	Completed
Phase	N/A
Start date	April 2005
Completion date	October 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03246984` - VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ	N/A
Completed	`NCT02922361` - Spending and Outcomes for Complex Medicare Advantage Patients
Completed	`NCT02235571` - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients	N/A
Completed	`NCT01930396` - Use of Tinzaparin for Anticoagulation in Hemodialysis	Phase 4
Completed	`NCT01933789` - Improving Communication About Serious Illness	N/A
Completed	`NCT01922843` - A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis	Phase 2
Not yet recruiting	`NCT01674660` - Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients	N/A
Completed	`NCT01209403` - Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients	Phase 4
Not yet recruiting	`NCT01157260` - The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease	Phase 4
Completed	`NCT00753116` - Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension	Phase 1
Recruiting	`NCT00532688` - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure	Phase 2/Phase 3
Completed	`NCT00534144` - Comparison Between Effects of Two Iron Preparations on Protein in the Urine	Phase 1
Completed	`NCT00528788` - How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis	Phase 4
Completed	`NCT00382044` - Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients	N/A
Completed	`NCT00226902` - Vascular Reactivity in Kidney Disease Patients	N/A
Recruiting	`NCT00235287` - Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease	Phase 4
Completed	`NCT00224081` - DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)	Phase 4
Completed	`NCT00071214` - Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis	Phase 3
Completed	`NCT00049907` - Cardiac and Renal Disease Study (CARDS)	N/A
Completed	`NCT00006297` - Risk Factors for CV Disease in a Dialysis Cohort	N/A