Renal Denervation by Allegro System in Patients With Resistant Hypertension (NCT01874470) | Clinical Trial Compass
TerminatedPhase 3
Renal Denervation by Allegro System in Patients With Resistant Hypertension
China3 participantsStarted 2013-05
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Change in office-based systolic blood pressure (SBP) from baseline to 6 months