Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Completed

Conditions: Hypertension

Treatments: Procedure: Bilateral radiofrequency sympathetic renal denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT01499810

012

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

53 participants in 1 patient group

Renal denervation

Experimental group

Description:

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.

Treatment:

Procedure: Bilateral radiofrequency sympathetic renal denervation