Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

NCT ID: NCT01499810

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal denervation

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.

Group Type: EXPERIMENTAL

Bilateral radiofrequency sympathetic renal denervation

Intervention Type: 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

Interventions

Bilateral radiofrequency sympathetic renal denervation

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

Intervention Type: PROCEDURE

Other Intervention Names

Transcatheter renal denervation; Percutaneous radiofrequency ablation of renal nerves

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Stanislav Pekarskiy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanislav E Pekarskiy, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Tomsk, , Russia

Countries

Russia

References

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

Reference Type: 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.

Reference Type: DERIVED

PMID: 26482895 (View on PubMed)

Other Identifiers

012

Identifier Type: -

Identifier Source: org_study_id