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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01617551

Acronym

RENO

Enrollment

Registered

2012-06-12

Start date

2012-03-31

Completion date

2014-06-30

Last updated

2014-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

Essential hypertension, Nitric oxide, Renal denervation, Sodium, GFR

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.

Interventions

DRUGNG-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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Contacts

Primary ContactJesper N Bech, MD, Ph.D

jnbech@dadlnet.dk+45 41627639

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026