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Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients

NCT ID: NCT00689819

Last Updated: 2013-12-03

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension High Blood Pressure Ventricular Hypertrophy Diastolic Dysfunction Systolic Dysfunction

Keywords

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Hypertension High blood pressure Pre-clinical cardiac dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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)

Intervention Type 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.

BP < 120/80 mmHg

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

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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.

Weight Loss

Intervention Type BEHAVIORAL

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.

Low Sodium Diet

Intervention Type BEHAVIORAL

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.

Smoking Cessation

Intervention Type BEHAVIORAL

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.

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type DRUG

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Phillip D. Levy

Research Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Phillip D. Levy, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Wayne State University Department of Emergency Medicine

Locations

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Detroit Receiving Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32622346 (View on PubMed)

Other Identifiers

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0803305872

Identifier Type: -

Identifier Source: org_study_id