Skip to main content
Clinical Trials/NCT00689819
NCT00689819
Completed
Not Applicable

Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients in an Urban Emergency Department: Is a Program Focused on Early Detection and Blood Pressure Control Clinically and Cost Effective?

Wayne State University1 site in 1 country123 target enrollmentOctober 2008

Overview

Phase
Not Applicable
Intervention
Exercise
Conditions
Hypertension
Sponsor
Wayne State University
Enrollment
123
Locations
1
Primary Endpoint
Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
June 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Phillip D. Levy

Research Investigator

Wayne State University

Eligibility 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)

Arms & Interventions

BP < 140/90 mmHg

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.

Intervention: Exercise

BP < 140/90 mmHg

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.

Intervention: Weight Loss

BP < 140/90 mmHg

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.

Intervention: Low Sodium Diet

BP < 140/90 mmHg

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.

Intervention: Smoking Cessation

BP < 140/90 mmHg

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.

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

BP < 120/80 mmHg

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

Intervention: Exercise

BP < 120/80 mmHg

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

Intervention: Weight Loss

BP < 120/80 mmHg

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

Intervention: Low Sodium Diet

BP < 120/80 mmHg

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

Intervention: Smoking Cessation

BP < 120/80 mmHg

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

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

Outcomes

Primary Outcomes

Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life

Time Frame: 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 Outcomes

  • Change in Prevalence of PCCD(Baseline and 1 year)

Study Sites (1)

Loading locations...

Similar Trials