Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension (SYMPATHY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by UMC Utrecht
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Medtronic
Information provided by (Responsible Party):
P. J. Blankestijn, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01850901
First received: March 21, 2013
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

The aim of this study is to assess whether renal denervation (RD) added to usual care compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at least 135 mmHg as determined with use of ABPM, despite use of three or more BP lowering agents or with documented intolerance or contraindication for to 2 or more of the 4 major classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics) obstructing use of 3 antihypertensives

Further aims are to assess the effect of renal denervation on the use of BP lowering agents, to explore the effect of renal denervation in strata of estimated glomerular filtration rate (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR>60 mL/min per 1.73m2) and according to baseline office BP.

Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.


Condition Intervention Phase
Hypertension
Chronic Kidney Disease
Procedure: Renal sympathetic denervation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension - A Multicenter Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Change in BP (measured by ABPM) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in BP: average day-time systolic blood pressure (SBP) as determined with the use of ambulatory blood pressure-monitoring at 6 months and during prolonged follow up (total 2 years)


Secondary Outcome Measures:
  • Change in the amount of antihypertensive medication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in antihypertensive medication defined as daily defined dose (DDD) of all prescribed drugs after 6 months and during prolonged follow up (total: 2 years)

  • Change in BP in eGFR strata [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The effect on BP of RD in strata of eGFR: eGFR 20-60 mL/min per 1.73m2 versus eGFR>60 mL/min per 1.73m2 at 6 months after intervention and during prolonged follow up (total 2 years)

  • Change in office BP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in office blood pressure at 6 months after intervention and during follow up (total 2 years)


Other Outcome Measures:
  • Impact on quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Impact on quality of life of RD will be measured with Short-Form 36 and EuroQol-5 Dimensions (EQ-5D) measurement instruments. Assessments at 6 months and during prolonged follow up (total 2 years)

  • Cost-effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cost-effectiveness of RD will be calculated. For this purpose, health care and indirect costs will be monitored with use of data from the case report form and questionnaires. Absence from work will be assessed using parts of the Short-Form Health and Labour Questionnaire. Assessments at 6 months and during prolonged follow up (total 2 years)


Estimated Enrollment: 300
Study Start Date: May 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal sympathetic denervation
Catheter-based renal nerve ablation
Procedure: Renal sympathetic denervation
No Intervention: Usual care
Antihypertensive treatment according to guidelines

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Individual has a mean day-time SBP ≥ 135 mmHg, as determined with the use of ABPM, while using 3 or more antihypertensive agents for at least 3 months prior to inclusion or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs ( ACE/ARB, Calcium channel blocker, Beta Blocker, Diuretic) and no possibility to take 3 anti-hypertensive drugs.
  2. Individual is ≥18 years of age.

Exclusion Criteria:

  1. Individual is unable or unwilling to sign informed consent.
  2. Individual has a treatable secondary cause of hypertension.
  3. Individual has an eGFR below 20 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) calculation.
  4. Individual has renal artery anatomy that is ineligible for treatment
  5. 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.
  6. Individual is pregnant, nursing or planning to be pregnant.
  7. 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.
  8. Individual is currently enrolled in another investigational drug or device trial.
  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: NCT01850901

Contacts
Contact: Peter J Blankestijn, MD, PhD +31307557329 P.J.Blankestijn@umcutrecht.nl

Locations
Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands
Principal Investigator: Peter J Blankestijn         
Sub-Investigator: Rosa L de Jager         
Sub-Investigator: Esther de Beus         
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Medtronic
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: P. J. Blankestijn, Peter J. Blankestijn, nephrologist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01850901     History of Changes
Other Study ID Numbers: 12-540
Study First Received: March 21, 2013
Last Updated: May 15, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Hypertension
Renal denervation
Sympathetic denervation

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 14, 2014