Effect of Renal Denervation on NO-mediated Sodium Excretion and Plasma Levels of Vasoactive Hormones

Not Applicable

• Conditions: Essential Hypertension
• Interventions: Drug: NG-monomethyl-L-arginine (L-NMMA)

• Registration Number: NCT01617551
• Lead Sponsor: Regional Hospital Holstebro

Brief Summary

Catheter based renal denervation (CRD) in humans represents a promising new treatment of resistant hypertension. CRD is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which CRD reduce blood pressure are only partly understood and the interaction between renal sympathetic nerves and nitric oxide (NO) has not been investigated in humans.

To Study the interaction between NO and renal sympathetic nerves, we designed the present substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are studied before and after CRD.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-12
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Last Update Submitted: 2014-03-01
• Last Update Posted: 2014-03-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 30-70 years
• Stable antihypertensive treatment for 1-month with at least 3 antihypertensive drugs including a diuretic
• Day-time ambulatory blood pressure > 145/75 mmHg

Exclusion Criteria

• Non compliance
• Pregnancy/no-anticonception in fertile women
• Radiocontrast allergy
• Malignancy
• Congestive heart failure (EF < 50)
• eGFR < 45
• Unstable angina pectoris
• Recent myocardial infarction or PCI (< 6 mdr)
• Secondary hypertension
• Renal artery stenosis or multiple renal arteries on CT
• Claudication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal denervation	NG-monomethyl-L-arginine (L-NMMA)	Patient group randomized to renal denervation
Sham	NG-monomethyl-L-arginine (L-NMMA)	Patients randomized to sham procedure

Primary Outcome Measures

Name	Time	Method
Fractional excretion of sodium after acute L-NMMA treatment	1 month before and after CRD

Secondary Outcome Measures

Name	Time	Method
Glomerular filtration rate (GFR) before and after L-NMMA treatment	1 month before and after CRD

Trial Locations

Locations (1)

Dept. of medical research; 🇩🇰 Holstebro, Denmark