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Hypertensive Ambulatory Trial to Compare the Efficacy of HCTZ and Lisinopril

Information source: Scripps Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension, Grade 1; Hypertension Treatment; N of 1 Study Design; Hypertension

Intervention: Lisinopril (Drug); Hydrochlorothiazide (Drug)

Phase: N/A

Status: Completed

Sponsored by: Scripps Translational Science Institute

Official(s) and/or principal investigator(s):
Bradley Patay, MD, Principal Investigator, Affiliation: Scripps Clinic

Summary

The purpose of this trial is to evaluate if an objective clinical decision of anti-hypertensive therapy can be made using an N-of-1 (single patient) trial design.

Clinical Details

Official title: Series of Single Patient Trials Comparing the Efficacy Between the Most Commonly Prescribed Thiazide Diuretic in the US, Hydrochlorothiazide, and Lisinopril for the Treatment of Stage 1 Hypertension.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Blood pressure control defined as 24-hour ambulatory systolic and diastolic pressure average below 135/85 mmHg.

Secondary outcome: Blood Pressure (BP) load, treatment of non-dippers, side effects, and compliance.

Detailed description: Personalized medicine involves choosing the optimal treatment for a patient based on data gathered by the physician that is specific to that individual. The N-of-1 or single patient trial is a study design motivated by the new era of personalized medicine. The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommends a personalized medicine approach to hypertensive drug class choice based on compelling indications. However, the hypertensive decision algorithm is limited. With the advent of new technology the amount of data available to a physician has grown substantially improving the robustness of surveying a more complete picture of the patient's health care status. Medicine is quickly becoming data intensive with new technology decreasing the cost of data collection and analysis. The typical standard care for patients with stage 1 hypertension first involves a non-pharmacological modification of lifestyle changes. Health care providers diagnose hypertension when the blood pressure is persistently elevated after three to six visits over a several month period. JNC 7 recommends thiazide-type diuretics for Stage I hypertension for most patients. In the United States, this recommendation results in most patients being given a dose of hydrochlorothiazide (HCTZ) at 12. 5 to 25 mg per day. A patient would then return for follow-up and would be prescribed a few month supply of an antihypertensive medication (e. g. HCTZ or lisinopril). The choice of treatment by the physician is based on JNC 7 guidelines, patient's risk factors, and a provider's experience. The objective of this trial will be to evaluate if an objective clinical decision of anti-hypertensive therapy can be made using an N-of-1 (single patient) trial design. In this study we propose to do a series of N-of-1 trials in patients with stage 1 hypertension who will be randomized to alternating courses of HCTZ and lisinopril.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of Grade 1 Hypertension

- Treatment naïve

- GFR > 60 within previous 3 months

- Urinary microalbumin level normal during previous 3 months

Exclusion Criteria:

- Pregnancy (Fetal morbidity and mortality may occur with the use of ACE inhibitors.)

- Uncontrolled Hyperthyroidism

- Sleep Apnea

- Primary Aldosteronism

- Renovascular Disease

- Cushing's Syndrome or steroid therapy

- No evidence of end organ damage

- EKG with evidence of LVH within previous 3 months

- Collagen Vascular Disease

- Current Smoker

Locations and Contacts

Scripps Clinic, La Jolla, California 92037, United States
Additional Information

Starting date: November 2010
Last updated: May 19, 2015

Page last updated: August 23, 2015

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