Clinical trial NCT01874470: Renal Denervation by Allegro System in Patients With Resistant Hypertension
Official title: Renal Denervation by Allegro System in Patients With Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Renal Denervation
Resistant Hypertension
Standard Medication
Lead sponsor: Shanghai AngioCare Medical
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system


Eligibility criteria: Inclusion Criteria:

* Age 18 - 65 years at time of randomization
* Stable medication regimen including 3 or more antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and no expected changes for at least 6 months
* 1) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour average SBP and/or DBP ≥140 and/or 90 mmHg
* Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
* eGFR≥45 mL/min/1.73 m2
* Written informed consent

Exclusion Criteria:

* Type 1 diabetes mellitus
* Secondary hypertension
* Has an implantable cardioverter defibrillator (ICD) or pacemaker
* Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
* Intravascular thrombosis or unstable atherosclerotic plaques
* Has hemodynamically significant valvular heart disease
* Pregnant, nursing, or planning to be pregnant
* Any serious medical condition that may adversely affect the safety of the participant or the study
* Currently enrolled in another investigational drug or device trial

Angiographic Exclusion Criteria:

* Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
* History of prior renal artery intervention including balloon angioplasty or stenting
* Multiple renal arteries where the main renal artery is estimated to supply \<75% of the kidney
* Main renal arteries with \<4 mm diameter or with \<20 mm treatable length (by visual estimation)
* Renal artery abnormalities

Primary outcomes:
measure: Change in office-based systolic blood pressure (SBP) from baseline to 6 months
timeFrame: 6 month
Secondary outcomes:
measure: Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months
timeFrame: 6 month
measure: • The incidence of major adverse events (MAE) at 1 month postrandomization
timeFrame: 1-month post randomization
measure: Office SBP and DBP at 1, 3, 6 months postrandomization
timeFrame: up to 6 months
measure: • Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization
timeFrame: up to 6 months
measure: • MAE at 6-month post-randomization, including new renal artery stenosis >60%
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
Study officials:
References: