Status:
COMPLETED
Trial of Low and High Intensity Strategies to Maintain BP Control
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The long-range goal of this research is to advance understanding of long-term blood pressure (BP) control in patients with uncontrolled hypertension (HTN). The work builds on our experience in impleme...
Detailed Description
We are proposing a 4-year trial to determine if long-term blood pressure (BP) control after a pharmacist intervention requires continuation of the intervention or if a less intense strategy is equally...
Eligibility Criteria
Inclusion
- Diagnosis of Hypertension (HTN) captured by ICD-9-CM codes from prior outpatient visits;
- elevated BP (\>140/90 mmHg among non-diabetics; or \>140/80 mmHg among diabetics) during the most recent VA clinic visit or based on the average from the last 3 visits;
- elevated BP measured by the Research Medical Assistant (MA) at the baseline visit.
Exclusion
- Patients will be excluded for the following safety reasons:
- prior history or current signs of hypertensive emergency including symptoms of angina, stroke, or acute renal failure;
- severe HTN (systolic BP \>200 or diastolic BP \> 114mm Hg);
- history of acute MI, stroke, or unstable angina in the prior 6 months;
- Congestive Heart Failure (CHF) due to systolic dysfunction with a left ventricular ejection fraction \< 35% documented by echocardiography, nuclear medicine study, or ventriculography;
- renal insufficiency, defined by a glomerular filtration rate less than 30 ml/min or previously documented proteinuria \> 1 gram per day;
- significant hepatic disease, including prior diagnoses of cirrhosis, Hepatitis B or C infection, or laboratory abnormalities (serum ALT or AST \> 2 times control or total bilirubin \> 1.5 mg/dl) in the prior 6 months;
- pregnancy;
- prior diagnoses of pulmonary hypertension or sleep apnea (unless treated by continuous positive pressure ventilation);
- poor prognosis with a life expectancy estimated less than 2 years;
- residence in a nursing home or diagnosis of dementia;
- inability to give informed consent or impaired cognitive function (defined as \> 3 errors on the 10-item Pfeiffer Portable Mental Status Questionnaire, administered during study intake);
- no telephone for follow-up calls.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT00760552
Start Date
November 1 2009
End Date
December 1 2013
Last Update
April 27 2015
Active Locations (1)
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1
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2208