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

Essential Hypertension Clinical Trial

— RENO  

Official title:

Effect of Renal Denervation on NO-mediated Regulation of Salt- and Water Excretion, Vasoactive Hormones and Tubular Transport Proteins in Patients With Resistant Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01617551
• Other study ID #: RENO_01
• Status: Recruiting
• Phase: N/A
• First received: June 6, 2012
• Last updated: March 1, 2014
• Start date: March 2012
• Est. completion date: June 2014

Study information

• Verified date: March 2014
• Source: Regional Hospital Holstebro
• Contact: Jesper N Bech, MD, Ph.D
• Phone: +45 41627639
• Email: jnbech[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• NG-monomethyl-L-arginine (L-NMMA)
Acute L-NMMA treatment (4,5 mg/kg loading dose followed by 3 mg/kg sustain infusion for 1 hour)

Locations

Country	Name	City	State
Denmark	Dept. of medical research	Holstebro

Sponsors (2)

Lead Sponsor	Collaborator
Regional Hospital Holstebro	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional excretion of sodium after acute L-NMMA treatment		1 month before and after CRD	No
Secondary	Glomerular filtration rate (GFR) before and after L-NMMA treatment		1 month before and after CRD	No