Renal Denervation by Allegro System in Patients With Resistant Hypertension

NCT01874470 | Terminated Phase 3 DMC

• 1 other identifier: Allegro-HTN
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Denervation; Resistant Hypertension; Standard Medication

Outcome Measures

Primary Outcomes (1)

• Change in office-based systolic blood pressure (SBP) from baseline to 6 months

  6 month

Secondary Outcomes (5)

• 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

Study Arms (2)

standard medication

PLACEBO COMPARATOR

Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic

Other: standard medication

renal denervation

EXPERIMENTAL

Allegro Renal Denervation System (AngioCare)

Device: renal denervation; Other: standard medication

Interventions

renal denervation DEVICE

Also known as: Allegro Renal Denervation System (AngioCare)

renal denervation

standard medication OTHER

Also known as: Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic

renal denervation; standard medication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \) 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Shanghai AngioCare Medical: lead

Study Sites (1)

Fuwai hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2013
• First Posted: June 11, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 20, 2016

Record last verified: 2013-12

Locations

CN (1)