Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients

Not Applicable

Completed

Conditions: Diastolic Dysfunction
Ventricular Hypertrophy
Systolic Dysfunction
High Blood Pressure
Hypertension

Interventions: Behavioral: Exercise
Behavioral: Weight Loss
Behavioral: Low Sodium Diet
Behavioral: Smoking Cessation
Drug: Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines)

Registration Number: NCT00689819

Lead Sponsor: Wayne State University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 123

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BP < 140/90 mmHg	Exercise	This arm will target a blood pressure of \< 140/90 mmHg (or \< 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
BP < 140/90 mmHg	Weight Loss	This arm will target a blood pressure of \< 140/90 mmHg (or \< 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
BP < 140/90 mmHg	Low Sodium Diet	This arm will target a blood pressure of \< 140/90 mmHg (or \< 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
BP < 140/90 mmHg	Smoking Cessation	This arm will target a blood pressure of \< 140/90 mmHg (or \< 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
BP < 140/90 mmHg	Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines)	This arm will target a blood pressure of \< 140/90 mmHg (or \< 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
BP < 120/80 mmHg	Exercise	This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.
BP < 120/80 mmHg	Weight Loss	This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.
BP < 120/80 mmHg	Low Sodium Diet	This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.
BP < 120/80 mmHg	Smoking Cessation	This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.
BP < 120/80 mmHg	Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines)	This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.

Primary Outcome Measures

Name	Time	Method
Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life	Baseline and 1 year	To evaluate the ability of this program to produce (as a surrogate for heart failure prevention) a clinically significant difference in blood pressure lowering, health status and quality of life between the 2 treatment groups.

Secondary Outcome Measures

Name	Time	Method
Change in Prevalence of PCCD	Baseline and 1 year	To measure the change from baseline to 1 year prevalence of pre-clinical cardiac dysfunction in randomized study patients.