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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01874470
Other study ID # Allegro-HTN
Secondary ID
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


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
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