Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients

November 7, 2013 updated by: Phillip D. Levy, Wayne State University

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Experimental: BP < 120/80 mmHg
This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

Robert Wood Johnson Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0803305872

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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