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

NCT01617551 | Unknown

• 1 other identifier: RENO_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fractional excretion of sodium after acute L-NMMA treatment

  1 month before and after CRD

Secondary Outcomes (1)

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

  1 month before and after CRD

Study Arms (2)

Renal denervation

EXPERIMENTAL

Patient group randomized to renal denervation

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

Sham

SHAM COMPARATOR

Patients randomized to sham procedure

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

Interventions

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

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

Renal denervation; Sham

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regional Hospital Holstebro: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Dept. of medical research

Holstebro, 7500, Denmark

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Interventions

omega-N-Methylarginine

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Arginine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Jesper N Bech, MD, Ph.D

  Dept. of medical research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesper N Bech, MD, Ph.D

CONTACT

+45 41627639; jnbech@dadlnet.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, Dr.Sci.

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 12, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 4, 2014

Record last verified: 2014-03

Locations

DK (1)