Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension

NCT ID: NCT02988245

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-12-31

Brief Summary

Hypertension is one of the most important preventable contributors to disease and death in the United States and represents the most common condition seen in the primary care setting. Approximately 78 million adults living in the U.S. have hypertension with more than 5 million new diagnoses made each year. Unfortunately, despite a significant impulse in the medical community to move towards an "individualized medicine" approach to patient centered treatment, the current clinical treatment strategy is based on a set algorithm which does not take into account individual patient differences. As a result hypertension is often sub-optimally treated based on "population averages", rather than a person's genetic make-up, with significant burden on our health care system. In fact, 40% of patients who are adherent to their blood pressure therapy (taking their medicines as prescribed by their clinician) do not have their blood pressure under control. Previous work has demonstrated significant functional polymorphisms within the kidney, vessels, and heart that will likely predict a patient's response to blood pressure pharmacotherapy. Previous work by our group, utilizing a retrospective design, has determined that the addition of genetic knowledge to prescribing can improve therapeutic guidance and decrease the time to blood pressure control significantly. Despite this, to date, there are no prospective trials to guide blood pressure therapy using multiple organ systems that are important in the three most common classes of drugs: diuretics, vasodilators, and beta-blockers. The objective of this clinical trial is to determine the efficacy of genetically guided therapeutic options for pharmacologic treatment of essential hypertension in newly diagnosed patients.

Detailed Description

Specific Aim:

To determine the efficacy of genetically guided therapeutic options for pharmacologic treatment of essential hypertension, when compared to conventional standard of care (JNC 8 guideline directed therapy).

Hypothesis A: Patients randomized to genetically guided blood pressure therapy will have significantly reduced time to optimal blood pressure control compared to conventional standard of care.

Hypotheses B: Patients randomized to genetically guided blood pressure therapy will have significantly greater absolute blood pressure reduction compared to conventional standard of care.

Hypothesis C: Patients randomized to genetically guided blood pressure therapy will have to take fewer classes of blood pressure medicines in order to achieve blood pressure control.

Secondary Aim:

To determine if genetically guided blood pressure therapy reduces number of medication changes in patients with hypertension.

Hypotheses: Patients randomized to genetically guided blood pressure therapy will have significantly less medication changes.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Genetically-Guided Treatment for HTN

Using a patient's genetic composition to guide BP prescribing for patients with hypertension, post diagnosis.

Group Type: EXPERIMENTAL

Geneticure Panel for HTN therapy

Intervention Type: DRUG

Using either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension

JNC-8-Guided Treatment

Using traditional (JNC-8) guidelines for BP prescribing for patients with hypertension, post diagnosis.

Group Type: ACTIVE_COMPARATOR

JNC-8

Intervention Type: DRUG

Using JNC-8 guidelines to guide therapy

Interventions

Geneticure Panel for HTN therapy

Using either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension

Intervention Type: DRUG

JNC-8

Using JNC-8 guidelines to guide therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject with new diagnosis of hypertension or uncontrolled hypertension and on one medication

2. Subject is able and willing to provide informed consent

3. Subject is ≥ 30 and ≤ 80 years of age

4. Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 50

Exclusion Criteria

1. Subject has been diagnosed with chronic kidney disease as determined by serum creatinine levels of >1.3 mg/dl for men and >1.1 for women.

2. Subject has clinically significant cardiac disease as determined by diagnosed coronary artery disease, diagnosed heart failure, and congenital cardiac disease.

3. Subject has clinically significant vascular disease as determined by diagnosed peripheral vascular disease and diagnosed pulmonary hypertension.

4. Liver dysfunction is defined using the normal reference range for lower limit of normal and upper limit of normal used by Fairview labs and as determined by diagnosed liver disease /cirrhosis as listed in the patient's problem list based on ICD-10.

5. Subject has secondary hypertension.

6. Subject has prior diagnosis of endocrine disorders except uncomplicated type 2 diabetes and well controlled hypothyroidism.

7. Subject is pregnant.

8. Subject is breastfeeding.

9. Subject becomes pregnant during study

10. Subjects lacking the capacity to consent

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fairview Health Services

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Geneticure, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Phelps, PharmD

Role: PRINCIPAL_INVESTIGATOR

Fairview Health Services

Weihong Tang, MD, PhD

Role: STUDY_DIRECTOR

University of Minnesota

Michael Schulenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Fairview Health Services

Locations

Fairview Health Clinics - Andover

Andover, Minnesota, United States

Fairview Health Clinics - Blaine

Blaine, Minnesota, United States

Fairview Health Clinics - Bloomington, Oxboro

Bloomington, Minnesota, United States

Fairview Clinics - Brooklyn Park

Brooklyn Park, Minnesota, United States

Fairview Clinics- Burnsville

Burnsville, Minnesota, United States

Fairview Clinics - Columbia Heights

Columbia Heights, Minnesota, United States

Fairview Health Clinics - Edina

Edina, Minnesota, United States

Fairview Health Clinics - Elk River

Elk River, Minnesota, United States

Fairview Clinics - Fridley

Fridley, Minnesota, United States

Fairview Clinics - Lino Lakes

Lino Lakes, Minnesota, United States

Fairview Clinics - Hiawatha

Minneapolis, Minnesota, United States

Fairview Clinic - New Brighton

New Brighton, Minnesota, United States

Fairview Clinics - North Branch

North Branch, Minnesota, United States

Fairview Clinics - Wyoming

Wyoming, Minnesota, United States

Fairview Health Services - Zimmerman

Zimmerman, Minnesota, United States

Countries

United States

Central Contacts

Eric M Snyder, PhD

Role: CONTACT

eric@geneticure.com

18003628109 ext. 702

Thomas P Olson, PhD

Role: CONTACT

tom@geneticure.com

18003628109 ext. 703

Related Links

http://www.geneticure.com

Sponsor Site

Other Identifiers

Geneticure

Identifier Type: -

Identifier Source: org_study_id