Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients

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.

Conditions

• Hypertension
• High Blood Pressure
• Ventricular Hypertrophy
• Diastolic Dysfunction
• Systolic Dysfunction

Interventions

BEHAVIORAL

Exercise

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.

BEHAVIORAL

Exercise

Blood pressure (BP) target will be \< 120/80 mmHg. 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.

BEHAVIORAL

Weight Loss

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.

BEHAVIORAL

Low Sodium Diet

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.

BEHAVIORAL

Smoking Cessation

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.

DRUG

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

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.

BEHAVIORAL

Weight Loss

Blood pressure (BP) target will be \< 120/80 mmHg. 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.

BEHAVIORAL

Low Sodium Diet

Blood pressure (BP) target will be \< 120/80 mmHg. 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.

BEHAVIORAL

Smoking Cessation

Blood pressure (BP) target will be \< 120/80 mmHg. 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.

DRUG

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

Blood pressure (BP) target will be \< 120/80 mmHg. 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.

Sponsors & Collaborators

• Robert Wood Johnson Foundation

  collaborator OTHER

• Wayne State University

  lead OTHER

Principal Investigators

• Phillip D. Levy, M.D., M.P.H. · Wayne State University Department of Emergency Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2011-05-31

Completion

2011-06-30

Countries

• United States

Study Locations