Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

NCT01499810 | Completed Results

• 1 other identifier: 012
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center, single group study of the efficacy and safety of transcatheter renal denervation for treatment of patients with essential hypertension uncontrolled despite combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic. Bilateral transcatheter renal denervation will be performed on the top of existed pharmacotherapy. Change in blood pressure (BP), left ventricle (LV) mass, carotid artery thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months of follow-up.

Conditions

Hypertension

Keywords

Hypertension; Radiofrequency Catheter Ablation; Renal Artery; Sympathetic Nerve Block

Outcome Measures

Primary Outcomes (2)

• Change in Office Systolic BP

  from baseline to 12 months

• Number of Serious Adverse Events

  A number of first occurrences (within the study period) of any of the following: death, end-stage renal disease, an embolic event resulting in end-organ damage, major bleeding event, renal artery thrombosis, new renal artery stenosis, other serious cardiovascular complications if their relation to the study treatment is assessed at least as possible.

  from baseline to 12 months

Secondary Outcomes (48)

• Change in Office Diastolic BP

  from baseline to 12 months

• Change in Mean 24-h Systolic BP

  from baseline to 12 months

• Change in Mean 24-h Diastolic BP

  from baseline to 12 months

• Change in Office Systolic BP

  from baseline to 6 month

• Change in Office Diastolic BP

  from baseline to 6 month

Study Arms (1)

Renal denervation

EXPERIMENTAL

All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.

Procedure: Bilateral radiofrequency sympathetic renal denervation

Interventions

Bilateral radiofrequency sympathetic renal denervation PROCEDURE

Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways

Also known as: Transcatheter renal denervation, Percutaneous radiofrequency ablation of renal nerves

Renal denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 80 years at time of randomization
• Informed consent
• Treatment with full doses of 3 or more anti-hypertensive medications of different classes, of which one is a diuretic.
• Office Systolic BP (SBP) ≥ 160 mmHg or Diastolic BP (DBP) ≥ 100 mmHg

You may not qualify if:

• An estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73 m2
• Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP \< 135 mmHg or DBP \< 85 mmHg
• Symptomatic(secondary) hypertension
• Severe renal artery stenosis or renal arteries abnormalities
• Individual is pregnant, nursing or planning to be pregnant
• Severe hepatic dysfunction
• Any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences

Tomsk, 634012, Russia

Location

Related Publications (2)

• S. Pekarskiy, A. Baev, V. Mordovin, T. Ripp, G. Semke, V. Lichikaki, E. Sitkova, A. Krylov, S. Popov, R. Karpov, Renal denervation by endocardial ablation system, European Heart Journal, Volume 34, Issue suppl_1, 1 August 2013, 3788, https://doi.org/10.1093/eurheartj/eht309.3788

  BACKGROUND

• Ripp TM, Mordovin VF, Pekarskiy SE, Ryabova TR, Zlobina MV, Baev AE, Anfinogenova Y, Popov SV. Predictors of Renal Denervation Efficacy in the Treatment of Resistant Hypertension. Curr Hypertens Rep. 2015 Dec;17(12):90. doi: 10.1007/s11906-015-0603-8.

  PMID: 26482895 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Stanislav Pekarskiy
• Organization: Research Institute of Cradiology, Siberian Branch of Russian Academy of Sciences

pekarski@cardio-tomsk.ru

+73822558122

Study Officials

• Stanislav E Pekarskiy, MD

  Institute of Cardiology, Siberian Branch of the Russian Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: March 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: October 28, 2021
• Results First Posted: September 17, 2014

Record last verified: 2021-10

Locations

RU (1)