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

March 21, 2013
May 15, 2014
May 2013
June 2016   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01850901 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
  • 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)
Same as current
 
Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension
Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension - A Multicenter Randomized Controlled Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Chronic Kidney Disease
Procedure: Renal sympathetic denervation
  • Experimental: Renal sympathetic denervation
    Catheter-based renal nerve ablation
    Intervention: Procedure: Renal sympathetic denervation
  • No Intervention: Usual care
    Antihypertensive treatment according to guidelines
Vink EE, de Beus E, de Jager RL, Voskuil M, Spiering W, Vonken EJ, de Wit GA, Roes KC, Bots ML, Blankestijn PJ. The effect of renal denervation added to standard pharmacologic treatment versus standard pharmacologic treatment alone in patients with resistant hypertension: rationale and design of the SYMPATHY trial. Am Heart J. 2014 Mar;167(3):308-314.e3. doi: 10.1016/j.ahj.2013.11.010. Epub 2013 Dec 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
June 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Peter J Blankestijn, MD, PhD +31307557329 P.J.Blankestijn@umcutrecht.nl
Netherlands
 
NCT01850901
12-540
Yes
P. J. Blankestijn, UMC Utrecht
UMC Utrecht
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Medtronic
Not Provided
UMC Utrecht
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP