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Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients - NCT00689819-48201(Clinical Trial 224284)



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City:  Detroit
State:  
MI
Zip Code: 48201
Conditions: Hypertension - High Blood Pressure - Ventricular Hypertrophy - Diastolic Dysfunction - Systolic Dysfunction
Purpose: This project will evaluate the clinical and cost effectiveness of a novel, multidisciplinary approach to identify and treat pre-clinical cardiac dysfunction (PCCD) in asymptomatic hypertensive patients identified in a single center urban emergency department. Premature onset of pressure-related cardiac complications of hypertension (especially heart failure) has important implications for long-term survival, quality of life and healthcare costs. This project will target patients who have already developed pressure-related cardiac structural abnormalities yet remain symptom free. These individuals are at tremendous risk for progression to clinically overt heart failure and its associated consequences. We hypothesize that detection and treatment of patients with hypertension who have pre-clinical structural cardiac damage will enable forestallment of the disease process and offer the opportunity to reduce the burden of cardiac morbidity associated with hypertension. This project will implement a program to prospectively identify PCCD (using echocardiography) and provide treatment. At present, the optimal blood pressure goal for patients with PCCD is unknown so this study will randomize patients to 2 levels of blood pressure control: "normal", which is consistent with current national guidelines and "intensive", which will aim for a markedly lower blood pressure (< 120/80). Enrolled patients will receive active treatment and follow-up for 1 year. At the end of 1 year, we will evaluate: 1) the ability of this program to achieve blood pressure goals; 2) the cost effectiveness; and 3) the proportion in each blood pressure group who have evidence of disease regression on echocardiography.
Study summary:
Criteria: Inclusion Criteria: - Blood pressure > or = 140/90 after 1 hour - Asymptomatic state as defined by Goldman Specific Activity Scale Exclusion Criteria: - Dyspnea (exertional or nocturnal) or chest pain as a primary or secondary chief complaint - Prior history of heart failure, coronary artery disease, myocardial infarction, cardiomyopathy, valvular heart disease or renal failure (with current, previous, or planned future dialysis) - Patients with acute illness or injury which necessitates hospital admission - Standing relationship with usual source of health care (i.e., primary care provider)
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Data Source: ClinicalTrials.gov
Date Processed: November 11, 2010
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