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Renal Denervation by Allegro System in Patients With Resistant Hypertension | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Renal Denervation by Allegro System in Patients With Resistant Hypertension

NCT01874470•Shanghai AngioCare Medical

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
•Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
+4 more criteria

Locations (1)

Fuwai hospital

Beijing, China

Key Dates

Start Date

May 1, 2013

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2014

Last Updated

October 20, 2016

Enrollment

ACTUAL participants

Conditions

Renal DenervationResistant HypertensionStandard Medication

Interventions

renal denervation

DEVICE

standard medication

OTHER

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RECRUITING

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Renal Denervation by Allegro System in Patients With Resistant Hypertension

Inclusion Criteria

Exclusion Criteria

Endothelin-1 Receptor Blockade in Resistant Hypertension

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Endocalyx in Treatment Resistent Hypertension

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