Denervation of the REnal Artery in Metabolic Syndrome

NCT01465724 | Completed Phase 3

• 1 other identifier: 11-265
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The current prevalence of hypertension as part of the metabolic syndrome is substantial and is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a common and key factor in disease states as obesity-related hypertension (ORH). The renal sympathetic nerves are a major contributor to the complex pathophysiology of this elevated SNS activity. Percutaneous renal denervation (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity. This current study is an observational feasibility study, with the aim to investigate the effect of renal denervation on changes in insulin resistance and blood pressure in patients with obesity related hypertension. The investigators will study different variables: a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory. Hypothesis

• The investigators hypothesize that renal denervation has a beneficial effect on insulin resistance.
• The investigators hypothesize that there will be no complications related to the device or procedure.

Conditions

Insulin Resistance; Blood Pressure

Keywords

Insulin resistance; Insulin sensitivity; HOMA-IR; blood pressure; Renal denervation; renal sympathetic denervation; renal ablation

Outcome Measures

Primary Outcomes (1)

• Difference in Insulin resistance before and 12 months after renal denervation

  To investigate the influence of percutaneous renal sympathetic denervation on insulin resistance. Hereby evaluating an Oral Glucose Tolerance Test before and after renal denervation

  T=0, T=6 months, and t=12 months

Secondary Outcomes (4)

• Difference in blood pressure before and after renal denervation

  t=0, t=6 months, and t=12 months

• Safety

  one year

• Fasting glucose before and after renal denervation

  t=0 and t=12 months

• Change in Muscle sympathetic nerve activity (MSNA)after renal denervation

  t=0 and t=6 months

Study Arms (1)

Renal denervation

EXPERIMENTAL

Procedure: Renal denervation

Interventions

Renal denervation PROCEDURE

percutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system.

Also known as: Symplicity Catheter system

Renal denervation

Eligibility Criteria

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

You may qualify if:

• Patients should fulfil one or more other criteria to meet the definition of the metabolic syndrome.
• Individual understands the study procedures, alternative treatments available, risks involved with the study and voluntarily agrees to participate by giving informed consent.
• Individual is over 18 years of age on the day of signing informed consent.

You may not qualify if:

• SBP \>180 mmHg and/or DBP \>110 mmHg during one or more screening measurements.
• Individual has a treatable secondary cause of hypertension.
• Individual has renal artery anatomy that is ineligible for treatment.
• Individual has an estimated glomerular filtration rate (eGFR) of \<45mL/min/1.73m2, using the MDRD calculation.
• Individual has type 1 diabetes mellitus.
• Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
• Individual has scheduled or planned surgery or cardiovascular intervention in the next 6 months.
• Individual has hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous.
• Individual has an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for RF energy delivery.
• Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, or significant anaemia).
• Individual is pregnant, nursing or planning to be pregnant.
• Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
• Individual is currently enrolled in another investigational drug or device trial.
• Individual is currently being treated with any of the following medications:
• Drugs that cause salt retention (e.g., systemic corticosteroids and fludrocortisone)

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, Netherlands

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michiel Voskuil, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Willemien Verloop, MD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal investigator

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: November 7, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

NL (1)