Renal Denervation by Allegro System in Patients With Resistant Hypertension

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

Study Overview

• Status: Terminated
• Conditions: Resistant Hypertension; Renal Denervation; Standard Medication
• Intervention / Treatment: Other: standard medication; Device: renal denervation

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: standard medication; Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic	Other: standard medication; Other Names: Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic
Experimental: renal denervation; Allegro Renal Denervation System (AngioCare)	Other: standard medication; Other Names: Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic; Device: renal denervation; Other Names: Allegro Renal Denervation System (AngioCare)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in office-based systolic blood pressure (SBP) from baseline to 6 months	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months	Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months	6 month
• The incidence of major adverse events (MAE) at 1 month postrandomization		1-month post randomization
Office SBP and DBP at 1, 3, 6 months postrandomization		up to 6 months
• Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization		up to 6 months
• MAE at 6-month post-randomization, including new renal artery stenosis >60%		up to 6 months

Collaborators and Investigators

• Sponsor: Shanghai AngioCare Medical

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 1, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Estimate): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Natriuretic Agents; Antihypertensive Agents; Diuretics
• Other Study ID Numbers: Allegro-HTN