Impact of Renal SympAthetic DenerVation on Chronic HypErtension

Stopped early · Not applicable

Conditions studied: Uncontrolled Hypertension

In brief

Despite the development of many drug therapies designed to treat high blood pressure (hypertension), it remains a considerable and poorly managed health, social and economic burden. For various reasons, including the high health care costs of treatment, there are estimates that up to 65% of patients with high blood pressure have untreated and/or uncontrolled blood pressure (BP). Aside from its effect on kidney function, chronic high blood pressure increases the risk for stroke, and heart disease. It is also thought to be involved in the formation of irregular heartbeats. This link between high blood pressure and heart health has been well described, as has their combined effect on the aging and the obesity-battling Western world. A recently published study (Symplicity HTN-2 trial) established the benefit of a new treatment procedure, catheter-based renal sympathetic denervation (RSDN) for hypertension, as having enormous potential for the treatment of patients with high blood pressure. This multi-center trial will attempt to confirm and expand on these promising data. Patients who enroll in the trial will be followed for 4 years.

Key facts

Study ID: NCT01628198
Run by: Vivek Reddy
People needed: 38
Starts: 2011-10-01
Expected to finish: 2015-08-01
Last updated by the study team: 2018-01-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥ 18 and ≤ 85 years of age.
Refractory hypertension (per JNC-7, this is defined as BP ≥ 140/90 mmHg despite treatment with at least 3 anti-hypertensive drugs, at least one of which is a diuretic, or treatment by ≥ 4 anti-hypertensive drugs)
Stable anti-hypertensive drug regimen, where no modifications have occurred for at least 2 weeks.
Accessibility of renal vasculature.
Ability to understand the requirements of the study.
Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements.

You may not qualify if…

Subject has a known secondary cause of hypertension.
Subject has isolated White coat hypertension.
Subject has Type 1 Diabetes.
Subject has known significant renovascular abnormalities (e.g., significant renal artery stenosis, previous renal artery stenting or angioplasty that precludes the RSDN procedure because of no sites for ablation treatment, or the presence of an accessory renal artery in which the main renal artery is estimated to supply <75% of the kidney )
Significant renal artery stenosis is defined as > 50% diameter stenosis on renal angiography. Per the guidelines for noninvasive vascular laboratory testing: a report from the American Society of Echocardiography and the Society for Vascular Medicine and Biology, significant renal artery stenosis is defined by any one of the following criteria on renal duplex ultrasound; i) Renal artery to aorta peak systolic velocity ratio ≥ 3.5; ii) Peak Systolic Velocity > 200 cm/s with evidence of post-stenotic turbulence; iii) end diastolic velocity >150 cm/s ; iv) Resistive Index (RI) > 0.8; v) An occluded renal artery demonstrates no flow in the affected vessel.
Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
Subject has New York Heart Association (NYHA) Class III or IV congestive heart failure, due to either systolic or diastolic dysfunction.
Subject has an eGFR<45 ml/min/1.73m2 (calculated by using the modified diet in renal disease (MDRD) formula), and is not receiving dialysis.
Subject has orthostatic hypotension. (per the American Academy of Neurology/American Autonomic Society Conesus Statement, this is defined as a sustained reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of 10 mm Hg within 3 min of standing or head-up tilt to at least 60° on a tilt table)
Subject has a life expectancy < 1 year for any medical condition.
Subject is currently enrolled in another investigational drug or device trial that would interfere with this study.

Where it is running

Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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