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

NCT04060641 | Unknown

• 1 other identifier: GCERDN01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Geneticure for RDN Genetic Panel GENETIC

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

RDN Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Unable to provide written, informed, consent

Sponsors & Collaborators

• Geneticure, LLC: lead

Study Sites (1)

Baylor Scott and White Health

Dallas, Texas, 75246, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eric M Snyder

  Geneticure, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric M Snyder, PhD

CONTACT

(800) 362-8109; eric@geneticure.com

Monica K Akre

CONTACT

(800) 362-8109; monica@geneticure.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: December 5, 2019
• Primary Completion: May 1, 2022
• Study Completion: September 30, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)