Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension

NCT ID: NCT01850901

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Hypertension; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal sympathetic denervation

Catheter-based renal nerve ablation

Group Type: EXPERIMENTAL

Renal sympathetic denervation

Intervention Type: PROCEDURE

Usual care

Antihypertensive treatment according to guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Renal sympathetic denervation

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Medtronic

INDUSTRY

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

P. J. Blankestijn

Peter J. Blankestijn, nephrologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UMC Utrecht

Utrecht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 28264922 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24576513 (View on PubMed)

Other Identifiers

12-540

Identifier Type: -

Identifier Source: org_study_id