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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01865240
Date of registration:	27/05/2013
Prospective Registration:	No
Primary sponsor:	Baker Heart and Diabetes Institute
Public title:	Renal Denervation for Resistant Hypertension RDNP-2012-01
Scientific title:	Renal Denervation for Resistant Hypertension
Date of first enrolment:	February 2012
Target sample size:	5
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT01865240
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Australia

Contacts

Name:	Markus Schlaich, MD
Address:
Telephone:
Email:
Affiliation:	Baker IDI Heart & Diabetes Institute

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Device: Renal Denervation

Primary Outcome(s)

blood pressure control [Time Frame: 6 months post procedure]

Secondary Outcome(s)

Change in markers of arterial stiffness [Time Frame: baseline to 6 months]

Change in Quality of Life [Time Frame: baseline to 6 months]

Change in Left Ventricular Structure and Function [Time Frame: baseline to 6 months]

time to achieve blood pressure target [Time Frame: baseline to 6 months]

Serum and Urine Biochemistry [Time Frame: baseline to 6 months]

Change in markers of sympathetic nerve activity [Time Frame: baseline to 6 months]

number of drugs required to reach blood pressure target [Time Frame: baseline to 6 months]

Secondary ID(s)

NHMRC

008/12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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