Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
This trial is active, not recruiting.
|Conditions||hypertension, vascular diseases, cardiovascular diseases|
|Treatments||renal denervation using the symplicity renal denervation system, sham renal denervation, renal angiography|
|Start date||October 2013|
|End date||July 2014|
|Trial size||44 participants|
|Trial identifier||NCT01972139, HTN-4|
An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Reaching BP Goal
time frame: 6 months post-randomization
Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)
time frame: Baseline to 6 months
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Individual is on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic - Individual has office SBP greater than or equal to 140mmHg and less than 160mmHg - Individual has ABPM average SBP greater than or equal to 135 mmHg Exclusion Criteria: - Individual lacks appropriate renal artery anatomy - Individual has eGFR of less than 30 - Individual has Type I diabetes mellitus - Individual has had one or more episodes of orthostatic hypotension - Individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea - Individual has primary pulmonary hypertension - Individual has other concomitant conditions that may adversely affect the patient or the study outcomes - Individual is pregnant, nursing or planning to be pregnant - Individual has had a previous organ transplant
|Official title||Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4|
|Principal investigator||David Kandzari, MD|
|Description||After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.|
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