Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014