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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01258764
First received: December 9, 2010
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention
Hypertension, Grade 1
Hypertension Treatment
N of 1 Study Design
Hypertension
Drug: Lisinopril
Drug: Hydrochlorothiazide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Scripps Translational Science Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: November 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258764

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

Additional Information:
No publications provided

Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01258764     History of Changes
Other Study ID Numbers: STSI 10-5486
Study First Received: December 9, 2010
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Translational Science Institute:
hypertension
Blood Pressure control
hypertension treatment
antihypertensive
N of 1 study

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Hydrochlorothiazide
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiotonic Agents
Cardiovascular Agents
Diuretics
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Protective Agents
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014