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

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ClinicalTrials.gov Identifier: NCT01617551
Recruitment Status : Unknown
Verified March 2014 by Erling Bjerregaard Pedersen, Regional Hospital Holstebro.
Recruitment status was:  Recruiting
First Posted : June 12, 2012
Last Update Posted : March 4, 2014
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, 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.


Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: NG-monomethyl-L-arginine (L-NMMA) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2012
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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)




Primary Outcome Measures :
  1. Fractional excretion of sodium after acute L-NMMA treatment [ Time Frame: 1 month before and after CRD ]

Secondary Outcome Measures :
  1. Glomerular filtration rate (GFR) before and after L-NMMA treatment [ Time Frame: 1 month before and after CRD ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014

Keywords provided by Erling Bjerregaard Pedersen, 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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action