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Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

This study is currently recruiting participants.
Verified February 2013 by The Hospital District of Satakunta
Sponsor:
Information provided by (Responsible Party):
The Hospital District of Satakunta
ClinicalTrials.gov Identifier:
NCT01785732
First received: February 5, 2013
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based renal denervation causes substantial and sustained blood- pressure reduction in patients with resistant hypertension.

The purpose of RENSYMPIS is to study the effects of renal denervation on:

  1. Cardiovascular function
  2. Metabolic factors
  3. Inflammatory and endocrine factors
  4. Coagulation
  5. Sleep

Condition Intervention
Resistant Hypertension
 Procedure: Renal Denervation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital District of Satakunta:

Primary Outcome Measures:
  • Office blood pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ambulatory blood pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Insulin resistance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Renal denervation
Patients are randomized to renal denervation
 Procedure: Renal Denervation
Sympathetic renal denervation via renal arteries
No Intervention: Optimization of medical therapy
Antihypertensive treatment is optimized

  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resistant Hypertension (systolic blood pressure >160mmHg and 3 or more antihypertensive agents in use)
  • Age 30- 69 years
  • Written informed consent

Exclusion Criteria:

  • Secondary hypertension
  • Pseudohypertension
  • Pregnancy
  • Renal insufficiency (GFR <45ml/min)
  • Clinically significant stenotic valvular disease
  • Oral anticoagulation
  • CCS III-IV symptoms or CABG/PCI in previous 6 months
  • Prior stroke
  • Contrast agent allergy
  • inappropriate renal artery anatomy (< 4mm diameter, < 20mm length)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785732

Contacts
Contact: Tuomas Paana, M.D. +358 2 6277100 tuomas.paana@satshp.fi
Contact: Antti Ylitalo, M.D. Ph.D +358 2 6277100 antti.ylitalo@satshp.fi

Locations
Finland
Satakunta Central Hospital Recruiting
Pori, Finland
Contact: Tuomas Paana, M.D     +358 2 6277100     tuomas.paana@satshp.fi    
Principal Investigator: Tuomas Paana, M.D.            
Principal Investigator: Antti Ylitalo, M.D. Ph.D            
Principal Investigator: Risto Kaaja, M.D. Ph.D.            
Sponsors and Collaborators
The Hospital District of Satakunta
  More Information

No publications provided

Responsible Party: The Hospital District of Satakunta
ClinicalTrials.gov Identifier: NCT01785732     History of Changes
Other Study ID Numbers: SA-007
Study First Received: February 5, 2013
Last Updated: February 8, 2013
Health Authority: Finland: Institutional review board

Additional relevant MeSH terms:
Hypertension
Insulin Resistance
Vascular Diseases
Cardiovascular Diseases
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013