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
|Condition or disease||Intervention/treatment|
|Hypertension||Genetic: Geneticure for RDN Genetic Panel|
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|
|Estimated Enrollment :||30 participants|
|Official Title:||Association Between a Multi-Gene Panel and Renal Denervation Effectiveness in Patients With Hypertension|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||March 2020|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060641
|Contact: Eric M Snyder, PhD||(800) 362-8109 ext firstname.lastname@example.org|
|Contact: Monica K Akre||(800) 362-8109 ext email@example.com|
|Principal Investigator:||Eric M Snyder||Geneticure, LLC|