Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension

Hypertension Clinical Trial

— SYMPATHY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850901
• Other study ID #: 12-540
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2013
• Last updated: January 31, 2017
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Renal sympathetic denervation

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Medtronic, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact on quality of life	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)	6 months
Other	Cost-effectiveness	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)	6 months
Primary	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	Change in the amount of antihypertensive medication	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)	6 months
Secondary	Change in BP in eGFR strata	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)	6 months
Secondary	Change in office BP	Change in office blood pressure at 6 months after intervention and during follow up (total 2 years)	6 months