Trial record 1 of 1 for:    NCT01874470
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Renal Denervation by Allegro System in Patients With Resistant Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Shanghai AngioCare Medical
Sponsor:
Information provided by (Responsible Party):
Shanghai AngioCare Medical
ClinicalTrials.gov Identifier:
NCT01874470
First received: June 1, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Renal Denervation
Resistant Hypertension
Standard Medication
Device: renal denervation
Other: standard medication
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation by Allegro System in Patients With Resistant Hypertension

Resource links provided by NLM:


Further study details as provided by Shanghai AngioCare Medical:

Primary Outcome Measures:
  • Change in office-based systolic blood pressure (SBP) from baseline to 6 months [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1-month post randomization ] [ Designated as safety issue: Yes ]
  • Office SBP and DBP at 1, 3, 6 months postrandomization [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • • Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • • MAE at 6-month post-randomization, including new renal artery stenosis >60% [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: May 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: standard medication
Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic
Other: standard medication
Other Name: Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic
Experimental: renal denervation
Allegro Renal Denervation System (AngioCare)
Device: renal denervation
Other Name: Allegro Renal Denervation System (AngioCare)
Other: standard medication
Other Name: Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874470

Contacts
Contact: Xiongjing Jiang jxj103@hotmail.com

Locations
China
Fuwai hospital Recruiting
Beijing, China
Contact: Xiongjing Jiang       jxj103@hotmail.com   
Sponsors and Collaborators
Shanghai AngioCare Medical
  More Information

No publications provided

Responsible Party: Shanghai AngioCare Medical
ClinicalTrials.gov Identifier: NCT01874470     History of Changes
Other Study ID Numbers: Allegro-HTN
Study First Received: June 1, 2013
Last Updated: December 11, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Diuretics
Frovatriptan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Natriuretic Agents
Physiological Effects of Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014