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Renal Denervation by Allegro System in Patients With Resistant Hypertension

Primary Purpose

Renal Denervation, Resistant Hypertension, Standard Medication

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
renal denervation
standard medication
Sponsored by
Shanghai AngioCare Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Denervation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Fuwai hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

standard medication

renal denervation

Arm Description

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

Allegro Renal Denervation System (AngioCare)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
• The incidence of major adverse events (MAE) at 1 month postrandomization
Office SBP and DBP at 1, 3, 6 months postrandomization
• Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization
• MAE at 6-month post-randomization, including new renal artery stenosis >60%

Full Information

First Posted
June 1, 2013
Last Updated
October 19, 2016
Sponsor
Shanghai AngioCare Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01874470
Brief Title
Renal Denervation by Allegro System in Patients With Resistant Hypertension
Official Title
Renal Denervation by Allegro System in Patients With Resistant Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai AngioCare Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Denervation, Resistant Hypertension, Standard Medication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard medication
Arm Type
Placebo Comparator
Arm Description
Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic
Arm Title
renal denervation
Arm Type
Experimental
Arm Description
Allegro Renal Denervation System (AngioCare)
Intervention Type
Device
Intervention Name(s)
renal denervation
Other Intervention Name(s)
Allegro Renal Denervation System (AngioCare)
Intervention Type
Other
Intervention Name(s)
standard medication
Other Intervention Name(s)
Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic
Primary Outcome Measure Information:
Title
Change in office-based systolic blood pressure (SBP) from baseline to 6 months
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months
Description
Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months
Time Frame
6 month
Title
• The incidence of major adverse events (MAE) at 1 month postrandomization
Time Frame
1-month post randomization
Title
Office SBP and DBP at 1, 3, 6 months postrandomization
Time Frame
up to 6 months
Title
• Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization
Time Frame
up to 6 months
Title
• MAE at 6-month post-randomization, including new renal artery stenosis >60%
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fuwai hospital
City
Beijing
Country
China

12. IPD Sharing Statement

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Renal Denervation by Allegro System in Patients With Resistant Hypertension

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