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Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study) (RENSYMPIS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by The Hospital District of Satakunta.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01785732
First Posted: February 7, 2013
Last Update Posted: February 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Hospital District of Satakunta
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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

Primary Outcome Measures:
  • Office blood pressure [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Ambulatory blood pressure [ Time Frame: 2 years ]
  • Insulin resistance [ Time Frame: 2 years ]
  • Endothelial function [ Time Frame: 2 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: The Hospital District of Satakunta
ClinicalTrials.gov Identifier: NCT01785732     History of Changes
Other Study ID Numbers: SA-007
First Submitted: February 5, 2013
First Posted: February 7, 2013
Last Update Posted: February 11, 2013
Last Verified: February 2013