Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension

Hypertension Clinical Trial

Official title:

The Australian SHAM Controlled Clinical Trial of Renal DeNervation in Patients With Resistant Hypertension (AUSHAM-RDN-01)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444442
• Other study ID #: 002/15
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: April 2020

Study information

• Verified date: September 2023
• Source: Baker Heart and Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of catheter-based renal denervation in reducing blood pressure in patients with resistant hypertension compared to a sham procedure. Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be switched to a single pill triple combination treatment prior to the procedure.

A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35 patients in the sham control arm.

The duration of this study is 36 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• systolic office BP =140mmHg and ambulatory day time average =135mmHg despite concurrent treatment with =3 anti-hypertensive drugs

Exclusion Criteria:

• renal artery anatomy ineligible for treatment

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

• myocardial infarction, unstable angina or cerebrovascular accident within 3 months of screening visit

• life expectancy of <12 months

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Renal Denervation
Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries.

Other:
• Sham control
Arterial access only. No delivery of radio frequency energy to renal arteries.

Locations

Country	Name	City	State
Australia	Baker IDI Heart & Diabetes Institute	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Baker Heart and Diabetes Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in percentage of patients achieving BP target between groups	Change in percentage of patients achieving BP target between groups	6 months post procedure
Other	Change in percentage of patients with an ambulatory systolic BP reduction =5mmHg between groups	Change in percentage of patients with an ambulatory systolic BP reduction =5mmHg between groups	6 months post procedure
Other	Change in percentage of patients with an office systolic BP reduction =10mmHg between groups	Change in percentage of patients with an office systolic BP reduction =10mmHg between groups	6 months post procedure
Other	Change of sympathetic nerve activity between groups	Change of sympathetic nerve activity (MSNA, renal and whole body NE spillover) between groups	6 months post procedure
Other	Change in left ventricular function between groups	Change in left ventricular function (LV mass index, ejection fraction, diastolic filling) between groups	6 months post procedure
Other	Change in Serum Biochemistry between groups	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 between groups	6 months post procedure
Other	Change in Urine Biochemistry between groups	Urinary albumin creatinine ratio (UACR), 24 hour urinary creatinine clearance, sodium between groups	6 months post procedure
Other	Change in Quality of Life between groups	Change in Quality of life as assessed by relevant questionnaires between groups	6 months post procedure
Other	Change in cognitive function between groups	Change in cognitive function as assessed by relevant questionnaires and assessment tools between groups	6 months post procedure
Other	Change in microRNA expression between groups	Change in microRNA expression as assessed by relevant assays between groups	6 months post procedure
Primary	Change in ambulatory systolic blood pressure between groups	Difference in mean ambulatory systolic daytime blood pressure between RDN group and sham-control group at 6 month follow up.	6 months post procedure
Secondary	Change in mean 24h systolic blood pressure between groups	Change in mean 24h systolic blood pressure between RDN group and sham-control group at 6 month follow up.	6 months post procedure
Secondary	Change in mean night time systolic blood pressure between groups	Change in mean night time systolic blood pressure between RDN group and sham-control group at 6 month follow up.	6 months post procedure
Secondary	Change in mean office systolic blood pressure between groups	Change in mean office systolic blood pressure between RDN group and sham-control group at 6 month follow up.	6 months post procedure