Renal Sympathetic Denervation for the Management of Chronic Hypertension

NCT01628172 | Completed DMC

• 1 other identifier: GCO 11-0965
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

Despite the development of numerous drug therapies designed to treat hypertension, it remains a considerable and poorly managed health, social and economic burden. For various reasons, including the significant health care costs of treatment, there are estimates that up to 65% of hypertensive patients have untreated and/or uncontrolled blood pressure (BP). Aside from its impact on renal function, chronic hypertension significantly increases the risk for stroke, coronary artery disease, heart failure, and vascular disease. It is believed to be involved in the progression of cardiac arrhythmias. This link between hypertension and cardiovascular health has been well described; as has their combined effect on the aging and obesity-battling Western world. The recently published results of the Symplicity HTN-2 trial (Renal sympathetic denervation in patients with treatment resistant hypertension) establishing the therapeutic benefit of catheter-based renal sympathetic denervation for hypertension, have enormous potential for the management of a large and challenging patient population. The proposed, multicenter trial will attempt to confirm and expand on this promising data by conducting a double-blinded, placebo-controlled trial. Patients may qualify to participate in this research study if their doctor has determined that they have drug-resistant, chronic hypertension. Overall participation in this research study should be about 13 months which includes about 1 month to start the study procedure and 12 months of follow-up after the study procedure.

Conditions

Uncontrolled Hypertension

Keywords

renal sympathetic denervation; renal catheter ablation; hypertension

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour ambulatory BP

  Differences in 24-hour ambulatory blood pressure measurements recorded at baseline and at 6 months for each patient.

  baseline and at 6 months

Secondary Outcomes (4)

• change in office BP

  baseline, 6 months, and 12 months

• change in ambulatory BP

  baseline and at 12 months

• Renal artery dimensions

  baseline and at 6 months

• Creatinine

  baseline and at 6 months

Study Arms (2)

Biosense Webster Celcius Thermacool catheter

EXPERIMENTAL

These subjects will undergo catheter-based sympathetic renal denervation. Ablation arm

Device: Biosense Webster Celcius Thermacool catheter

renal angiogram only

NO INTERVENTION

Control Group: Control arm will not receive intervention but will be followed for 1 year.

Interventions

Biosense Webster Celcius Thermacool catheter DEVICE

catheter-based sympathetic renal denervation

Also known as: sympathetic renal denervation, Ablation arm

Biosense Webster Celcius Thermacool catheter

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 and ≤ 85 years of age
• Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring)
• Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic)
• 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:

• Secondary cause of hypertension
• White coat hypertension
• Estimated GFR \< 45
• Type 1 Diabetes
• Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
• Life expectancy \<1 year for any medical condition

Sponsors & Collaborators

• Vivek Reddy: lead
• Biosense Webster, Inc.: collaborator

Study Sites (2)

Fakultní nemocnice u sv. Anny v Brně

Brno, 53, 656 91, Czechia

Location

Na Homolce Hospital

Prague, 15030, Czechia

Location

Related Publications (26)

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Cardiac Arrhythmia Service, Professor of Medicine

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 26, 2012
• Study Start: January 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)