Renal Denervation by Allegro System in Patients With Resistant Hypertension

Resistant Hypertension Clinical Trial

Official title:

Renal Denervation by Allegro System in Patients With Resistant Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01874470
• Other study ID #: Allegro-HTN
• Status: Terminated
• Phase: Phase 3
• First received: June 1, 2013
• Last updated: October 19, 2016
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2013
• Source: Shanghai AngioCare Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Renal Denervation
• Resistant Hypertension
• Standard Medication

Intervention

Device:
• renal denervation

Other:
• standard medication

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai AngioCare Medical

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in office-based systolic blood pressure (SBP) from baseline to 6 months		6 month	No
Secondary	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	No
Secondary	• The incidence of major adverse events (MAE) at 1 month postrandomization		1-month post randomization	Yes
Secondary	Office SBP and DBP at 1, 3, 6 months postrandomization		up to 6 months	No
Secondary	• Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization		up to 6 months	No
Secondary	• MAE at 6-month post-randomization, including new renal artery stenosis >60%		up to 6 months	Yes