A Phase 2 interventional study of Geneticure Panel for HTN therapy and JNC-8 in Hypertension, sponsored by Geneticure, LLC. Status unknown at 15 sites in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-02.
Sponsored by Geneticure, LLC · Phase 2, Interventional, and Treatment
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.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Geneticure, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Using a patient's genetic composition to guide BP prescribing for patients with hypertension, post diagnosis.
Drug: Geneticure Panel for HTN therapy
Using traditional (JNC-8) guidelines for BP prescribing for patients with hypertension, post diagnosis.
Drug: JNC-8
Using either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension
Using JNC-8 guidelines to guide therapy
Time to Blood Pressure Control
Time to BP control between genetically-guided prescribing and JNC-8 guided prescribing
Time frame: 1 year
Change in Blood Pressure
Change (absolute) in BP (systolic, SBP, diastolic, DBP, and mean arterial, MAP) between genetically-guided prescribing and JNC-8 guided prescribing
Time frame: 1 year
Number of Blood Pressure Medicines
Number of blood pressure medicines needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing
Time frame: 1 year
Number of Medication Changes
Number of blood pressure medicine changes needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing
Time frame: 1 year
Plan to share: No
Start is estimated for Jun 2022; primary completion for May 2023, 11 months later.
Of 110 industry-sponsored phase 2 interventional studies under Hypertension, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 25. This study's planned 11 months is below that.
Counting every sponsor, half of 182 studies reached it within 23 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Geneticure, LLC