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临床试验/NCT02988245
NCT02988245Unknown2 期

Prospective Randomized Controlled Trial Investigating the Use of Genetic Predisposition to Guide Pharmacologic Therapy for Hypertension

Geneticure, LLC15 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
1,000
试验地点
15
主要终点
Time to Blood Pressure Control

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject with new diagnosis of hypertension or uncontrolled hypertension and on one medication
  • Subject is able and willing to provide informed consent
  • Subject is ≥ 30 and ≤ 80 years of age
  • Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 50

排除标准

  • 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.
  • Subject has clinically significant cardiac disease as determined by diagnosed coronary artery disease, diagnosed heart failure, and congenital cardiac disease.
  • Subject has clinically significant vascular disease as determined by diagnosed peripheral vascular disease and diagnosed pulmonary hypertension.
  • 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-
  • Subject has secondary hypertension.
  • Subject has prior diagnosis of endocrine disorders except uncomplicated type 2 diabetes and well controlled hypothyroidism.
  • Subject is pregnant.
  • Subject is breastfeeding.
  • Subject becomes pregnant during study
  • Subjects lacking the capacity to consent

研究组 & 干预措施

Genetically-Guided Treatment for HTN

Experimental

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

干预措施: Geneticure Panel for HTN therapy (Drug)

JNC-8-Guided Treatment

Active Comparator

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

干预措施: JNC-8 (Drug)

结局指标

主要结局

Time to Blood Pressure Control

时间窗: 1 year

Time to BP control between genetically-guided prescribing and JNC-8 guided prescribing

Change in Blood Pressure

时间窗: 1 year

Change (absolute) in BP (systolic, SBP, diastolic, DBP, and mean arterial, MAP) between genetically-guided prescribing and JNC-8 guided prescribing

Number of Blood Pressure Medicines

时间窗: 1 year

Number of blood pressure medicines needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing

次要结局

  • Number of Medication Changes(1 year)

研究者

发起方
Geneticure, LLC
申办方类型
Industry
责任方
Sponsor

研究点 (15)

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