Renal Denervation for Complicated Hypertension

Hypertension Clinical Trial

— RDNP-2012-03  

Official title:

Renal Denervation for Complicated Hypertension (RDNP-2012-03)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01865253
• Other study ID #: 087/12
• Secondary ID: 1034397
• Status: Terminated
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: March 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 an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to:

• intolerance to antihypertensive medication

• inability to take antihypertensive medication due to planned pregnancy

• renal artery stenosis

• chronic kidney disease

• non-compliance to antihypertensive medication

A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study.

The duration of this study is 36 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: March 2015
• Est. primary completion date: March 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)

• Intolerance to =2 antihypertensive drug classes

• Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy

• Renal artery stenosis

• Chronic Kidney Disease

Exclusion Criteria:

• renal artery anatomy ineligible for treatment

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

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Renal Denervation
Renal Denervation

Locations

Country	Name	City	State
Australia	Baker IDI Heart & Diabetes Institute	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	Change in average office blood pressure	Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure	baseline to 6 months post procedure
Secondary	Blood pressure control	Percentage of patients who achieved BP target at 6 months post procedure	baseline to 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 post procedure
Secondary	Time to achieve blood pressure target	Time to achieve blood pressure target	baseline to 6 months post procedure
Secondary	Change in sympathetic nerve activity	Change in muscle sympathetic nerve activity, renal and whole body Noradrenaline (NA) spillover	baseline to 6 months post procedure
Secondary	Change in left ventricular structure and function	Change in left Ventricular mass index, Ejection Fraction, diastolic filling	baseline to 6 months post procedure
Secondary	Change in Quality of life	Change in Quality of life as assessed by relevant questionnaires	baseline to 6 months post procedure
Secondary	Change in serum and urine Biochemistry	Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate(eGFR), Urinary Albumin Creatinine Ratio (UACR), inflammatory markers, 24hour urine creatinine clearance, sodium, fasting glucose, fasting insulin, c peptide, Homeostasis Model Assessment (HOMA) index, lipid profile.	baseline to 6 months post procedure
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