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

March 1, 2014 updated by: Erling Bjerregaard Pedersen, Regional Hospital Holstebro

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holstebro, Denmark, 7500
        • Recruiting
        • Dept. of medical research
        • Principal Investigator:
          • Jesper N Bech, MD, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal denervation
Patient group randomized to renal denervation
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)
Sham Comparator: Sham
Patients randomized to sham procedure
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fractional excretion of sodium after acute L-NMMA treatment
Time Frame: 1 month before and after CRD
1 month before and after CRD

Secondary Outcome Measures

Outcome Measure
Time Frame
Glomerular filtration rate (GFR) before and after L-NMMA treatment
Time Frame: 1 month before and after CRD
1 month before and after CRD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital Holstebro

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Jesper N Bech, MD, Ph.D, Dept. of medical research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 1, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RENO_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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