search
Back to results

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

Primary Purpose

Essential Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
NG-monomethyl-L-arginine (L-NMMA)
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Essential Hypertension focused on measuring Essential hypertension, Nitric oxide, Renal denervation, Sodium, GFR

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of medical researchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Renal denervation

Sham

Arm Description

Patient group randomized to renal denervation

Patients randomized to sham procedure

Outcomes

Primary Outcome Measures

Fractional excretion of sodium after acute L-NMMA treatment

Secondary Outcome Measures

Glomerular filtration rate (GFR) before and after L-NMMA treatment

Full Information

First Posted
June 6, 2012
Last Updated
March 1, 2014
Sponsor
Regional Hospital Holstebro
Collaborators
Aarhus University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01617551
Brief Title
Effect of Renal Denervation on NO-mediated Sodium Excretion and Plasma Levels of Vasoactive Hormones
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Essential hypertension, Nitric oxide, Renal denervation, Sodium, GFR

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal denervation
Arm Type
Experimental
Arm Description
Patient group randomized to renal denervation
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Patients randomized to sham procedure
Intervention Type
Drug
Intervention Name(s)
NG-monomethyl-L-arginine (L-NMMA)
Intervention Description
Acute L-NMMA treatment (4,5 mg/kg loading dose followed by 3 mg/kg sustain infusion for 1 hour)
Primary Outcome Measure Information:
Title
Fractional excretion of sodium after acute L-NMMA treatment
Time Frame
1 month before and after CRD
Secondary Outcome Measure Information:
Title
Glomerular filtration rate (GFR) before and after L-NMMA treatment
Time Frame
1 month before and after CRD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper N Bech, MD, Ph.D
Phone
+45 41627639
Email
jnbech@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper N Bech, MD, Ph.D
Organizational Affiliation
Dept. of medical research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of medical research
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper N Bech, MD, Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs