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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Eric M Snyder, PhD; Phone Number: 702 (800) 362-8109; Email: eric@geneticure.com
• Study Contact Backup: Name: Monica K Akre; Phone Number: 707 (800) 362-8109; Email: monica@geneticure.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott and White Health
      • Contact: Cara A East, MD; Phone Number: 214-826-6044; Email: east.cara@bswhealth.org
      • Contact: Merielle Boatman; Email: merielle.boatman@bswhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between genetic scoring and RDN effectiveness using office blood pressure	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.	6 months
Correlation between genetic scoring and RDN effectiveness using ambulatory blood pressure	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.	6 months

Collaborators and Investigators

• Sponsor: Geneticure, LLC
• Investigators: Principal Investigator: Eric M Snyder, Geneticure, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2019
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): September 30, 2022

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (ACTUAL): August 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: GCERDN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No