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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Regional Hospital Holstebro
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01617551
First received: June 6, 2012
Last updated: March 1, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Essential Hypertension
Drug: NG-monomethyl-L-arginine (L-NMMA)

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

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Fractional excretion of sodium after acute L-NMMA treatment [ Time Frame: 1 month before and after CRD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glomerular filtration rate (GFR) before and after L-NMMA treatment [ Time Frame: 1 month before and after CRD ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617551

Contacts
Contact: Jesper N Bech, MD, Ph.D +45 41627639 jnbech@dadlnet.dk

Locations
Denmark
Dept. of medical research Recruiting
Holstebro, Denmark, 7500
Principal Investigator: Jesper N Bech, MD, Ph.D         
Sponsors and Collaborators
Regional Hospital Holstebro
Aarhus University Hospital
Investigators
Principal Investigator: Jesper N Bech, MD, Ph.D Dept. of medical research
  More Information

No publications provided

Responsible Party: Erling Bjerregaard Pedersen, Professor, MD, Dr.Sci., Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01617551     History of Changes
Other Study ID Numbers: RENO_01
Study First Received: June 6, 2012
Last Updated: March 1, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Regional Hospital Holstebro:
Essential hypertension
Nitric oxide
Renal denervation
Sodium
GFR

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hormones
Omega-N-Methylarginine
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014