Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients

Wayne State University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00689819

0803305872

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

123 participants in 2 patient groups

BP < 140/90 mmHg

Active Comparator group

Description:

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.

Treatment:

Behavioral: Exercise

Behavioral: Low Sodium Diet

Drug: Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines)

Behavioral: Smoking Cessation

Behavioral: Weight Loss

Behavioral: Exercise

Drug: Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines)

Behavioral: Smoking Cessation

Behavioral: Low Sodium Diet

Behavioral: Weight Loss

BP < 120/80 mmHg

Experimental group

Description:

This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.

Treatment:

Behavioral: Exercise

Behavioral: Low Sodium Diet

Drug: Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines)

Behavioral: Smoking Cessation

Behavioral: Weight Loss

Behavioral: Exercise

Drug: Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines)

Behavioral: Smoking Cessation

Behavioral: Low Sodium Diet

Behavioral: Weight Loss