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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Renal denervation

Patient group randomized to renal denervation

Group Type EXPERIMENTAL

NG-monomethyl-L-arginine (L-NMMA)

Intervention Type DRUG

Acute L-NMMA treatment (4,5 mg/kg loading dose followed by 3 mg/kg sustain infusion for 1 hour)

Sham

Patients randomized to sham procedure

Group Type SHAM_COMPARATOR

NG-monomethyl-L-arginine (L-NMMA)

Intervention Type DRUG

Acute L-NMMA treatment (4,5 mg/kg loading dose followed by 3 mg/kg sustain infusion for 1 hour)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No