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Completed

NCT Number: NCT00689819

Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Diastolic Dysfunction High Blood Pressure Systolic Dysfunction Vascular Diseases Ventricular Hypertrophy

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Behavioral

Blood pressure (BP) target of < 140/90 mmHg (or < 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.

Weight Loss

Behavioral

Blood pressure (BP) target of < 140/90 mmHg (or < 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.

Low Sodium Diet

Behavioral

Blood pressure (BP) target of < 140/90 mmHg (or < 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.

smoking cessation

Behavioral

Blood pressure (BP) target of < 140/90 mmHg (or < 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.

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

Drug

Blood pressure (BP) target of < 140/90 mmHg (or < 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a combination of recommended life-style modifications (i.e., exercise, weight loss, low sodium diet, smoking cessation), and pharmaceutical therapy based on JNC 7 protocol driven guidelines with the following adaptations: 1) use of a diuretic that is appropriate to renal function (eGFR< 40 ml/min/1.73 m2: a loop diuretic; eGFR> 40 ml/min/1.73 m2: a thiazide); 2) use of automated reminders if BP exceeds target for > 4 weeks without a medication titration; 3) use of a second diuretic when taking 4 or more anti-hypertensives without adequate achievement of BP target level; and 4) automated alerts to study personnel for potential drug interactions.

Primary outcomes

  1. 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

  1. Change in Prevalence of PCCD

    Time frame: Baseline and 1 year

    To measure the change from baseline to 1 year prevalence of pre-clinical cardiac dysfunction in randomized study patients.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Official study 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?

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 4, 2008
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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