Clinical trial NCT00689819: Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients
Official title: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
High Blood Pressure
Ventricular Hypertrophy
Diastolic Dysfunction
Systolic Dysfunction
Keywords: Hypertension
High blood pressure
Pre-clinical cardiac dysfunction
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2008-06-04
Enrollment: 123
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Change in Prevalence of PCCD
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
Study officials:
affiliation: Wayne State University Department of Emergency Medicine
name: Phillip D. Levy, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy PD, Burla MJ, Twiner MJ, Marinica AL, Mahn JJ, Reed B, Brody A, Ehrman R, Brodsky A, Zhang Y, Nasser SA, Flack JM. Effect of Lower Blood Pressure Goals on Left Ventricular Structure and Function in Patients With Subclinical Hypertensive Heart Disease. Am J Hypertens. 2020 Sep 10;33(9):837-845. doi: 10.1093/ajh/hpaa108.