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Hypertensive Ambulatory Trial to Compare the Efficacy of HCTZ and Lisinopril (1HAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01258764
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : May 20, 2015
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension, Grade 1 Hypertension Treatment N of 1 Study Design Hypertension Drug: Lisinopril Drug: Hydrochlorothiazide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Lisinopril Drug: Lisinopril
Lisinopril 10 mg oral, once daily for four week cycle and a 2 week cycle
Other Names:
  • Prinivil
  • Zestril
  • ACE inhibitor

Active Comparator: Hydrochlorothiazide Drug: Hydrochlorothiazide
Hydrochlorothiazide 25 mg oral, once daily for 4 week cycle and a 2 week cycle
Other Names:
  • Aquazide H
  • Carozide
  • Diaqua
  • Esidrix
  • Ezide
  • Hydro Par
  • HydroDIURIL
  • Hydrocot
  • Hydrokraft
  • Loqua
  • Oretic
  • Thiazide
  • HCTZ

Primary Outcome Measures :
  1. Blood pressure control defined as 24-hour ambulatory systolic and diastolic pressure average below 135/85 mmHg. [ Time Frame: After 14 week study period with assessment of patient specific data ]

Secondary Outcome Measures :
  1. Blood Pressure (BP) load, treatment of non-dippers, side effects, and compliance. [ Time Frame: After 14 week study period with assessment of patient specific data ]
    BP load is defined as the percentage of ambulatory systolic and diastolic pressure exceeding 140 mmHg and 90 mmHg during the daytime and 120 mmHg and 80 mmHg during sleep. Systolic BP load averages 9-25% depending on age. While diastolic BP load averages 3-4%. Failure of BP to fall by at least 10 percent during sleep will define a non-dipper. Extreme dipping will be defined by a nocturnal BP decline of greater than 20 percent with a large morning increase in BP.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01258764

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United States, California
Scripps Clinic
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
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Principal Investigator: Bradley Patay, MD Scripps Clinic

Additional Information:
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Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute Identifier: NCT01258764     History of Changes
Other Study ID Numbers: STSI 10-5486
First Posted: December 13, 2010    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Keywords provided by Eric Topol, MD, Scripps Translational Science Institute:
Blood Pressure control
hypertension treatment
N of 1 study
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents