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Association Between a Multi-Gene Panel and Renal Denervation Effectiveness in Patients With Hypertension (GxRDxHTN)

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ClinicalTrials.gov Identifier: NCT04060641
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Geneticure, LLC

Study Description
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Brief Summary:
The purpose of this study is to assess the effectiveness of a multi-gene panel to determine which subjects are likely to respond to renal denervation therapy with Medtronic's Symplicity Spyral™ multi-electrode renal denervation system.

Condition or disease Intervention/treatment
Hypertension Genetic: Geneticure for RDN Genetic Panel

Detailed Description:

The objective of this study is to assess if renal denervation (RDN) effectiveness using the Symplicity SpyralTM multi-electrode renal denervation system is associated with ranked genomic scoring from the Geneticure multi-gene algorithm for renal denervation. The present study will assess if subjects who have a high genetic score, based on the hypothesized importance of the organ systems involved, will have differential responsiveness to RDN in a descending order. The genetic scoring is collectively ranked in a specific order, in that:

  • Subjects with a "high level of general functionality" (functionality in the sympathetic nervous system (SNS), cardiac, vascular (renin-angiotensin-aldosterone system (RAAS)), and renal system genotypes will be most responsive to RDN.
  • Subjects with high number of functional genotypes of SNS, cardiac, and RAAS will be the next most responsive group.
  • Subjects with functionality in genotypes of SNS and cardiac systems will demonstrate the next most responsive group.
  • Subjects with functionality in the SNS genotypes will demonstrate some degree of responsiveness.
  • Subjects with functionality in the renal system, but not SNS, cardiac, nor RAAS, will be the least responsive to this therapy.
Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association Between a Multi-Gene Panel and Renal Denervation Effectiveness in Patients With Hypertension
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
RDN Patients
Patients who have received renal denervation with the Medtronic SymplicitySpyral device will have DNA collected in using a buccal swab.
 Genetic: Geneticure for RDN Genetic Panel
This retrospective trial will include the collection of DNA using buccal swabs and the assessment of 22 genotypes for scoring to assess response to renal denervation


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between genetic scoring and RDN effectiveness using office blood pressure [ Time Frame: 6 months ]
    Change in office blood pressure (mmHg) from baseline to post- renal denervation procedure in subjects who have met the primary efficacy endpoints in the Symplicity Spyral studies (3-months for the HTN-OFF MED trial and 6-months for the HTN-ON MED trial) according to ranked genetic score values.

  2. Correlation between genetic scoring and RDN effectiveness using ambulatory blood pressure [ Time Frame: 6 months ]
    Change in ambulatory blood pressure (mmHg) from baseline to post- renal denervation procedure in subjects who have met the primary efficacy endpoints in the Symplicity Spyral studies (3-months for the HTN-OFF MED trial and 6-months for the HTN-ON MED trial) according to ranked genetic score values.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll subjects with uncontrolled hypertension, enrolled in one of Medtronic's clinical studies utilizing the Symplicity Spyral™ multi-electrode renal denervation system, and meet the inclusion/exclusion criteria listing in this protocol.
Criteria

Inclusion Criteria:

  1. Individual is currently or has previously been enrolled in a Medtronic clinical study utilizing the Symplicity Spyral™ multi-electrode renal denervation system.
  2. Subject received Renal Denervation.
  3. Subject has met the primary efficacy endpoint for the Medtronic Symplicity Spyral study and which arm they were randomized to.
  4. Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

  • Unable to provide written, informed, consent
Contacts and Locations
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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): NCT04060641


Contacts
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Contact: Eric M Snyder, PhD (800) 362-8109 ext 702 eric@geneticure.com
Contact: Monica K Akre (800) 362-8109 ext 707 monica@geneticure.com

Sponsors and Collaborators
Geneticure, LLC
Investigators
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Principal Investigator: Eric M Snyder Geneticure, LLC
More Information
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Responsible Party: Geneticure, LLC
ClinicalTrials.gov Identifier: NCT04060641    
Other Study ID Numbers: GCERDN01
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases