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 range
18 Years – 65 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in office-based systolic blood pressure (SBP) from baseline to 6 months