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Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients

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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00689819
Enrollment
123
Registered
2008-06-04
Start date
2008-10-31
Completion date
2011-06-30
Last updated
2013-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Hypertension, High blood pressure, Pre-clinical cardiac dysfunction

Brief 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.

Interventions

BEHAVIORALExercise

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.

BEHAVIORALWeight 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.

BEHAVIORALLow 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.

BEHAVIORALSmoking 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.

DRUGPharmaceutical 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.

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
Wayne State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of LifeBaseline and 1 yearTo 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

MeasureTime frameDescription
Change in Prevalence of PCCDBaseline and 1 yearTo measure the change from baseline to 1 year prevalence of pre-clinical cardiac dysfunction in randomized study patients.

Countries

United States

Participant flow

Participants by arm

ArmCount
Treatment 1
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.
65
Treatment 2
This arm will target a more aggressive blood pressure target of \< 120/80 mmHg.
58
Total123

Baseline characteristics

CharacteristicTreatment 2Treatment 1Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
58 Participants65 Participants123 Participants
Age Continuous49.6 years
STANDARD_DEVIATION 8.3
49.3 years
STANDARD_DEVIATION 8.1
49.4 years
STANDARD_DEVIATION 7.8
Region of Enrollment
United States
58 participants65 participants123 participants
Sex: Female, Male
Female
36 Participants44 Participants80 Participants
Sex: Female, Male
Male
22 Participants21 Participants43 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 650 / 58
serious
Total, serious adverse events
0 / 650 / 58

Outcome results

Primary

Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life

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: Baseline and 1 year

ArmMeasureValue (MEAN)
Treatment 1Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life-3.3 mm Hg
Treatment 2Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life-4.9 mm Hg
Secondary

Change in Prevalence of PCCD

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

Time frame: Baseline and 1 year

ArmMeasureValue (NUMBER)
Treatment 1Change in Prevalence of PCCD91.8 percentage of participants
Treatment 2Change in Prevalence of PCCD88.7 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026