Association Between Genetic Algorithm to Predict Hypertension Therapy and Response to Treatment

NCT03292900 | Completed

• 1 other identifier: Geneticure600
• Study Type: observational
• Target: 758
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effectiveness of the use of a patient's genes to predict which hypertension therapy is successful

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Level of Blood Pressure Control

  how many participants are \<140/\<90 with genetic prediction

  5 years

Secondary Outcomes (6)

• Number of medications needed to obtain blood pressure control

  5 years

• Time to blood pressure control

  5 years

• Number of office visits to obtain blood pressure control

  5 years

• side effects from hypertension therapy

  5 years

• Hypertension associated adverse events during the course of treatment

  5 years

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hypertensive patients who have achieved blood pressure control

You may qualify if:

• Subject is able and willing to provide informed consent
• Subject is ≥ 20 and ≤ 85 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 ≤ 45
• Subject is currently prescribed and taking one of the following classes of medications alone or in combination with each other.
• Diuretics (thiazide or thiazide-like)
• ACE Inhibitors
• Angiotensin Receptor Blocker (ARB)
• Beta-blockers
• Ca+ Channel Blockers

You may not qualify if:

• 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
• Subject has Systolic BP \> 190 or Diastolic BP \> 120 documented within the six months prior to visit.
• Any other reason that the subject is inappropriate for study enrollment in the opinion of the Investigator.

Sponsors & Collaborators

• Geneticure, LLC: lead
• Fairview Health Services: collaborator

Study Sites (1)

Fairview Clinic - New Brighton

New Brighton, Minnesota, 55112, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pamela Phelps, PharmD

  Fairview Health System

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 26, 2017
• Study Start: March 1, 2018
• Primary Completion: December 15, 2018
• Study Completion: January 15, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)