Pre-Clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients - Full Text View

Sponsors and Collaborators:	Wayne State University Robert Wood Johnson Foundation
Information provided by:	Wayne State University
ClinicalTrials.gov Identifier:	NCT00689819

Purpose

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.

Condition	Intervention
Hypertension High Blood Pressure Ventricular Hypertrophy Diastolic Dysfunction Systolic Dysfunction	Behavioral: Exercise Behavioral: Weight Loss Behavioral: Low Sodium Diet Behavioral: Smoking Cessation Drug: Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines)

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure High Blood Pressure Quitting Smoking Smoking Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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?

Further study details as provided by Wayne State University:

Primary Outcome Measures:

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate the costs per case of pre-clinical cardiac dysfunction identified and overall cost effectiveness of the program. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To measure the change in 1-year prevalence of pre-clinical cardiac dysfunction in randomized study patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	104
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment 1: Active Comparator 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.	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: 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.
Treatment 2: Experimental This arm will target a more aggressive blood pressure target of < 120/80 mmHg.	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 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.

Arms

Assigned Interventions

Treatment 1: Active Comparator

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.

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: 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.

Treatment 2: Experimental

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

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 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.

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689819

Contacts

Contact: Phillip D. Levy, M.D., M.P.H.	313-993-8558	plevy@med.wayne.edu
Contact: LynnMarie Mango, M.P.H.	313-745-4350	lmmango@med.wayne.edu

Locations

United States, Michigan
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201

Sponsors and Collaborators

Wayne State University

Robert Wood Johnson Foundation

Investigators

Principal Investigator:

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

Wayne State University Department of Emergency Medicine

More Information

Responsible Party:	Wayne State University Department of Emergency Medicine ( Phillip D. Levy, M.D., M.P.H. )
Study ID Numbers:	0803305872
Study First Received:	June 2, 2008
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00689819
Health Authority:	United States: Institutional Review Board

Keywords provided by Wayne State University:

Hypertension
High blood pressure
Pre-clinical cardiac dysfunction

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypertrophy
Vascular Diseases
Emergencies
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009