Hypertensive Ambulatory Trial to Compare the Efficacy of HCTZ and Lisinopril
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | November 2010 |
| End Date: | March 2014 |
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.
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.
anti-hypertensive therapy can be made using an N-of-1 (single patient) trial design.
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.
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.
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
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