NCT01850901

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started May 2013

Longer than P75 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3.2 years

First QC Date

March 21, 2013

Last Update Submit

January 31, 2017

Conditions

HypertensionChronic Kidney Disease

Keywords

HypertensionRenal denervationSympathetic denervation

Outcome Measures

Primary Outcomes (1)

  • Change in BP (measured by ABPM)

    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)

    6 months

Secondary Outcomes (3)

  • Change in the amount of antihypertensive medication

    6 months

  • Change in BP in eGFR strata

    6 months

  • Change in office BP

    6 months

Other Outcomes (2)

  • Impact on quality of life

    6 months

  • Cost-effectiveness

    6 months

Study Arms (2)

Renal sympathetic denervation

EXPERIMENTAL

Catheter-based renal nerve ablation

Procedure: Renal sympathetic denervation

Usual care

NO INTERVENTION

Antihypertensive treatment according to guidelines

Interventions

Renal sympathetic denervationPROCEDURE
Renal sympathetic denervation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individual is ≥18 years of age.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

  • de Jager RL, de Beus E, Beeftink MM, Sanders MF, Vonken EJ, Voskuil M, van Maarseveen EM, Bots ML, Blankestijn PJ; SYMPATHY Investigators. Impact of Medication Adherence on the Effect of Renal Denervation: The SYMPATHY Trial. Hypertension. 2017 Apr;69(4):678-684. doi: 10.1161/HYPERTENSIONAHA.116.08818.

    PMID: 28264922DERIVED

  • 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.

    PMID: 24576513DERIVED

MeSH Terms

Conditions

HypertensionRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Peter J. Blankestijn, nephrologist

Study Record Dates

First Submitted

March 21, 2013

First Posted

May 10, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

NL(1)