Relationship Between Genes Important in Blood Pressure Regulation and Blood Pressure Therapy in Hypertension

NCT02524873 | Completed

• 1 other identifier: GTC01
• Study Type: observational
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

Whether patients with a functional genotype of a protein important in blood pressure regulation respond better to a drug therapy class/combination of therapy classes that target that specific pathway using the Geneticure panel for high blood pressure

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Ambulatory blood pressure changes (using sphygmomanometry) in response to therapy according to genes important in blood pressure regulation

  To assess the relationship between the drug therapy class/combination of therapy classes that resulted in the best blood pressure control for a patient vs. what the Geneticure high blood pressure panel would have predicted. We will assess blood pressure values (systolic and diastolic blood pressure, in mmHg) at rest in patients on different blood pressure medications.

  one year

Secondary Outcomes (2)

• The clinical time to achieve optimal blood pressure treatment

  One year

• The number of office visits required to achieve optimal blood pressure treatment.

  One year

Interventions

Geneticure Collection Kit for Pharmaocogenetics of Hypertension DEVICE

Buccal (cheek) swab kit for DNA collection for analysis of genes for hypertension

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypertension

You may qualify if:

• Subject is able and willing to provide informed consent
• Subject is ≥ 30 and ≤ 70 years of age
• Subject with diagnosis of Hypertension for a minimum of 1 year
• Subject has been on the same class/classes of blood pressure medication for a minimum of 6 months. Note: A change in dosage, frequency, or specific medication is acceptable as long as there have been no changes to the class/classes of medications prescribed.
• Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 35
• Subject is currently prescribed and taking one of the following classes of medications alone or in combination with each other or a Ca+ channel blocker.
• Diuretics
• ACE Inhibitors
• Angiotensin Receptor Blocker (ARB)
• Beta-blockers

You may not qualify if:

• Subject has clinically significant kidney disease as determined by the investigator.
• Subject has clinically significant cardiac disease as determined by the investigator.
• Subject has clinically significant vascular disease as determined by the investigator.
• Subject has a diagnosis of secondary hypertension or is experiencing a complication of pregnancy.
• Subject is currently prescribed and taking any additional class of medication(s) for high blood pressure not included in the list above, with the exception of a Ca+ channel blocker.
• Subject has Systolic BP \> 190 or Diastolic BP \> 120 documented within the six months prior to visit.
• Subject has a regular alcohol intake of greater than 21 units per week in the past 6 months
• Subject has smoked greater than two packs of cigarettes (total) or equivalent nicotine intake in the past 6 months.
• Subject has an anticipated survival less than 12 months.
• Any other reason that the subject is inappropriate for study enrollment in the opinion of the Investigator.

Sponsors & Collaborators

• Geneticure, LLC: lead

Related Publications (2)

• Johnson MW, Sprissler R, Olson TP, Beenken GW, Snyder EM. Multi-Gene Pharmacogenetics and Blood Pressure Control in Patients with Hypertension. The FASEB Journal 30:942.1. 2016

  RESULT

• Johnson MW, Sprissler R, Olson TP, Beenken GW, Snyder EM. Time to Blood Pressure Control According to Drug Class in Patients with Hypertension. The FASEB Journal 30:941.12. 2016.

  RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Krista Kleve

  RCRI

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 17, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share