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, sham renal denervation|
|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 in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4|
|Principal investigator||David Kandzari, MD|
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