Recruiting

Multi-Gene Panel

Sponsor:

Geneticure, LLC

Code:

NCT04060641

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Geneticure for RDN Genetic Panel

Study Details

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.

Conditions

Hypertension

Study ID

NCT04060641

Start date

Dec 5, 2019

Status verified date

Feb, 2022

Completion date

Sep 30, 2022

Anticipated

Primary completion date

May 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

RDN Patients

Patients who have received renal denervation with the Medtronic SymplicitySpyral device will have DNA collected in using a buccal swab.

Interventions

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

Primary outcome measure

  • Correlation between genetic scoring and RDN effectiveness using office blood pressure [ Time Frame: 6 months ]
  • Correlation between genetic scoring and RDN effectiveness using ambulatory blood pressure [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Eric M Snyder, PhD

(800) 362-8109eric@geneticure.com

Monica K Akre

(800) 362-8109monica@geneticure.com

Locations

Baylor Scott and White Health

Recruiting

Dallas, Texas, United States, 75246

Contacts

Cara A East, MD

214-826-6044east.cara@bswhealth.org

Merielle Boatman

merielle.boatman@bswhealth.org

More Information

Sponsor

Geneticure, LLC

Last update posted

Feb 16, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Geneticure, LLC on 2022-02-16.