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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01874470
First Posted: June 11, 2013
Last Update Posted: October 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shanghai AngioCare Medical
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months [ Time Frame: 6 month ]
    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 ]
  • Office SBP and DBP at 1, 3, 6 months postrandomization [ Time Frame: up to 6 months ]
  • • Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization [ Time Frame: up to 6 months ]
  • • MAE at 6-month post-randomization, including new renal artery stenosis >60% [ Time Frame: up to 6 months ]

Enrollment: 3
Study Start Date: May 2013
Study Completion Date: May 2014
Primary Completion Date: May 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874470


Locations
China
Fuwai hospital
Beijing, China
Sponsors and Collaborators
Shanghai AngioCare Medical
  More Information

Responsible Party: Shanghai AngioCare Medical
ClinicalTrials.gov Identifier: NCT01874470     History of Changes
Other Study ID Numbers: Allegro-HTN
First Submitted: June 1, 2013
First Posted: June 11, 2013
Last Update Posted: October 20, 2016
Last Verified: December 2013

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