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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01865253
Other study ID # 087/12
Secondary ID 1034397
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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