Renal Denervation for Uncontrolled Hypertension

Hypertension Clinical Trial

— RDNP-2012-02  

Official title:

Renal Denervation for Uncontrolled Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02016573
• Other study ID #: 070/12
• Secondary ID: 1034397
• Status: Withdrawn
• Phase: N/A
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: November 2018
• Source: Baker IDI Heart and Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study investigating the safety and usefulness of the Renal Denervation Procedure in reducing high blood pressure in people whose blood pressure is not adequately controlled despite already being treated with 2 blood pressure lowering drugs. This study is designed to compare the effects renal denervation to a usual care group.

Description:

This is a phase 4 randomised control trial of renal denervation for the treatment of uncontrolled hypertension.

Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure.

A total of 100 participants with uncontrolled blood pressure, treated with two blood pressure lowering medications will be recruited into the study. Patients will be assigned to one of two groups. Participants in Group 1 will be assigned to undergo the renal denervation procedure. Participants in group 2 will undergo usual care, receiving additional antihypertensive medication in an attempt to reach blood pressure targets.

The duration of this study is 36 months.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• BP =140/90 mmHg (or =130/80 mmHg for patients with diabetes)

• concurrent treatment with 2 anti-hypertensive drugs

Exclusion Criteria:

• renal artery anatomy ineligible for treatment

• eGFR <15mL/min/1.73m2 (using MDRD formula)

• individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit

• female participants of child bearing potential must have negative pregnancy test prior to treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Renal Denervation
Renal Denervation Catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baker IDI Heart and Diabetes Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure control	percentage of patients who achieve BP target at 6 months post intervention	6 months post procedure
Secondary	number of drugs required to reach target blood pressure	number of drugs required to reach target blood pressure	baseline to 6 months
Secondary	time to achieve blood pressure target	time to achieve blood pressure target	baseline to 6 months
Secondary	change in sympathetic nerve activity	changes in muscle sympathetic nerve activity (MSNA), renal and whole body Noradrenaline (NA) spillover	baseline to 6 months
Secondary	Change in left ventricular function	Change in left Ventricular ejection fraction, diastolic filling	baseline to 6 months
Secondary	Change in Quality of Life	Change in Quality of life as assessed be relevant questionnaires	baseline to 6 months
Secondary	Change in Serum Biochemistry	Plasma Renin Activity, aldosterone levels, estimated Glomerular Filtration Rate(eGFR), inflammatory markers, fasting glucose, fasting insulin, C-peptide, Homeostasis Model Assessment (HOMA) index, Lipid profile	baseline to 6 months
Secondary	Change in markers of arterial stiffness	Change in markers of arterial stiffness as assessed by Augmentation Index (AI) and Pulse Wave Velocity (PWV)	baseline to 6 months
Secondary	Change in left ventricular structure	Change in left ventricular mass index	baseline to 6 months
Secondary	Change in Urine Biochemistry	Urinary albumin creatinine ratio (UACR), 24 hour urinary creatinine clearance, sodium	baseline to 6 months