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Completed

NCT Number: NCT01850901

Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UMC Utrecht

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Individual is ≥18 years of age.

Exclusion criteria

  • 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.

Treatment and study plan

Renal sympathetic denervation

Procedure

Primary outcomes

  1. Change in BP (measured by ABPM)

    Time frame: 6 months

    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 outcomes

  1. Change in the amount of antihypertensive medication

    Time frame: 6 months

    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)

  2. Change in BP in eGFR strata

    Time frame: 6 months

    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)

  3. Change in office BP

    Time frame: 6 months

    Change in office blood pressure at 6 months after intervention and during follow up (total 2 years)

Other outcomes

  1. Impact on quality of life

    Time frame: 6 months

    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)

  2. Cost-effectiveness

    Time frame: 6 months

    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)

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Medtronic
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension - A Multicenter Randomized Controlled Trial

Acronym: SYMPATHY

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 10, 2013
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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