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Trial record 3 of 4 for:    geneticure

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 : Unknown
Verified August 2019 by Geneticure, LLC.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Geneticure, LLC

Tracking Information
First Submitted Date August 15, 2019
First Posted Date August 19, 2019
Last Update Posted Date August 20, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 16, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Association Between a Multi-Gene Panel and Renal Denervation Effectiveness in Patients With Hypertension
Official Title Association Between a Multi-Gene Panel and Renal Denervation Effectiveness in Patients With Hypertension
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hypertension
Intervention 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
Study Groups/Cohorts RDN Patients
Patients who have received renal denervation with the Medtronic SymplicitySpyral device will have DNA collected in using a buccal swab.
Intervention: Genetic: Geneticure for RDN Genetic Panel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 16, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04060641
Other Study ID Numbers GCERDN01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Geneticure, LLC
Study Sponsor Geneticure, LLC
Collaborators Not Provided
Investigators
Principal Investigator: Eric M Snyder Geneticure, LLC
PRS Account Geneticure, LLC
Verification Date August 2019