Clinical trial NCT04060641: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: Geneticure, LLC
Sponsor class: INDUSTRY
First posted: 2019-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Correlation between genetic scoring and RDN effectiveness using office blood pressure
timeFrame: 6 months
measure: Correlation between genetic scoring and RDN effectiveness using ambulatory blood pressure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott and White Health
state: Texas
Study officials:
affiliation: Geneticure, LLC
name: Eric M Snyder
role: PRINCIPAL_INVESTIGATOR
References: