Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 30 - 80 |
Updated: | 4/4/2019 |
Start Date: | January 23, 2017 |
End Date: | March 31, 2019 |
Prospective Randomized Controlled Trial Investigating the Use of Genetic Predisposition to Guide Pharmacologic Therapy for Hypertension
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.
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.
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.
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.
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
We found this trial at
15
sites
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