Renal Denervation for Resistant Hypertension

Hypertension Clinical Trial

— RDNP-2012-01  

Official title:

Renal Denervation for Resistant Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01865240
• Other study ID #: 008/12
• Secondary ID: NHMRC
• Status: Terminated
• Phase: Phase 4
• Start date: February 2012
• Est. completion date: October 2013

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 effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.

Description:

Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• systolic BP =140mmHg or =130mmHg for patients with diabetes

• concurrent treatment with =3 anti-hypertensive drugs

Exclusion Criteria:

• renal artery anatomy ineligible for treatment

• eGFR <15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)

• female participants of childbearing 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
Australia	Baker IDI Heart & Diabetes Inst	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Baker IDI Heart and Diabetes Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure control	percentage of patients to achieve Blood Pressure (BP) target (BP <140/90mmHg, or <130/80mmHg in diabetic patients) at 6 months post procedure	6 months post procedure
Secondary	number of drugs required to reach blood pressure target	number of drugs required to reach blood pressure target	baseline to 6 months
Secondary	time to achieve blood pressure target	time to achieve blood pressure target	baseline to 6 months
Secondary	Change in markers of sympathetic nerve activity	Changes in Muscle Sympathetic Nerve Activity (MSNA), renal and whole body Norepinephrine (NE) spillover	baseline to 6 months
Secondary	Change in Left Ventricular Structure and Function	Change in Left Ventricular mass index, ejection fraction, diastolic filling as assessed by echocardiogram	baseline to 6 months
Secondary	Change in Quality of Life	Change in Quality of Life as assessed by relevant questionnaires	baseline to 6 months
Secondary	Serum and Urine Biochemistry	Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate (eGFR), urine albumin-to-creatinine ratio (UACR), inflammatory markers, 24hour urinary creatinine clearance, sodium, 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 including Augmentation Index (AI) and Pulse Wave Velocity (PWV)	baseline to 6 months