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

Regional Hospital Holstebro

Status: Unknown

Conditions: Essential Hypertension

Treatments: Drug: NG-monomethyl-L-arginine (L-NMMA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01617551

RENO_01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Renal denervation

Experimental group

Description:

Patient group randomized to renal denervation

Treatment:

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

Sham

Sham Comparator group

Description:

Patients randomized to sham procedure

Treatment:

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