N/A N=53 Treatment

Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01499810 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Change in Office Systolic BP — -31.1 mmHg — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Bilateral radiofrequency sympathetic renal denervation (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Office Systolic BP	-27.1	<0.0001 sig
PRIMARY Number of Serious Adverse Events	—	—
SECONDARY Change in Office Diastolic BP	-13.3	<0.0001 sig
SECONDARY Change in Mean 24-h Systolic BP	-10.3	0.0001 sig
SECONDARY Change in Mean 24-h Diastolic BP	-6.2	<0.0001 sig
SECONDARY Change in Office Systolic BP	-27.1	<0.0001 sig
SECONDARY Change in Office Diastolic BP	-13.3	<0.0001 sig
SECONDARY Change in Mean 24-h Systolic BP	-10.3	0.0001 sig
SECONDARY Change in Mean 24-h Diastolic BP	-6.2	<0.0001 sig
SECONDARY Change in Echocardiographic Left Ventricular Mass	-14.6	0.12
SECONDARY Change in Echocardiographic Left Ventricular Mass	-14.6	0.12
SECONDARY Change in Mean Daytime Systolic BP	-12.3	0.00004 sig
SECONDARY Change in Mean Daytime Diastolic BP	-7.7	0.0001 sig
SECONDARY Change in Mean Daytime Systolic BP	-12.3	0.00004 sig
SECONDARY Change in Mean Daytime Diastolic BP	-7.7	0.0001 sig
SECONDARY Change in Mean Nighttime Systolic BP	-11.2	0.0004 sig
SECONDARY Change in Mean Nighttime Diastolic BP	-7.3	0.0002 sig
SECONDARY Change in Mean Nighttime Systolic BP	-11.2	0.0004 sig
SECONDARY Change in Mean Nighttime Diastolic BP	-7.3	0.0002 sig
SECONDARY Change in Mean Nighttime Systolic BP Dipping	-0.23	0.87
SECONDARY Change in Mean Nighttime Diastolic BP Dipping	0.47	0.77
SECONDARY Change in Mean Nighttime Systolic BP Dipping	-0.23	0.87
SECONDARY Change in Mean Nighttime Diastolic BP Dipping	0.47	0.77
SECONDARY Change in Daytime Systolic BP Variability	-0.2	0.72
SECONDARY Change in Daytime Diastolic BP Variability	0.4	0.37
SECONDARY Change in Nighttime Systolic BP Variability	-0.01	0.99
SECONDARY Change in Nighttime Diastolic BP Variability	0.2	0.76
SECONDARY Change in Daytime Systolic BP Variability	-0.2	0.72
SECONDARY Change in Daytime Diastolic BP Variability	0.4	0.37
SECONDARY Change in Nighttime Systolic BP Variability	-0.01	0.99
SECONDARY Change in Nighttime Diastolic BP Variability	0.2	0.76
SECONDARY Change in Serum Creatinine	1.9	0.22
SECONDARY Change in Serum Creatinine	1.9	0.22
SECONDARY Change in Serum Creatinine	1.9	0.22
SECONDARY Change in Casual Proteinuria	0.05	0.65
SECONDARY Change in Casual Proteinuria	0.05	0.65
SECONDARY Change in Casual Proteinuria	0.05	0.65
SECONDARY Change in Specific Gravity of Urine	-0.07	0.92
SECONDARY Change in Specific Gravity of Urine	-0.07	0.92
SECONDARY Change in Specific Gravity of Urine	-0.07	0.92
SECONDARY Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery	-0.008	0.32
SECONDARY Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery	0.010	0.40
SECONDARY Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery	-0.011	0.17
SECONDARY Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery	-0.019	0.014 sig
SECONDARY Change in Ultrasound Intima Media Thickness of Carotid Artery	—	—
SECONDARY Change in Ultrasound Intima Media Thickness of Carotid Artery	—	—
SECONDARY Change in Arterial Stiffness	—	—
SECONDARY Change in Arterial Stiffness	—	—
SECONDARY Change in Morning Surge of BP	—	—
SECONDARY Change in Morning Surge of BP	—	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01499810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.