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| Name | Class |
|---|---|
| Robert Wood Johnson Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BP < 140/90 mmHg | 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. |
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| BP < 120/80 mmHg | Experimental | This arm will target a more aggressive blood pressure target of < 120/80 mmHg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Prevalence of PCCD | To measure the change from baseline to 1 year prevalence of pre-clinical cardiac dysfunction in randomized study patients. | Baseline and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip D. Levy, M.D., M.P.H. | Wayne State University Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit Receiving Hospital | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32622346 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Treatment 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Exercise | 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. |
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| Weight Loss | 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. |
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| Low Sodium Diet | 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. |
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| Smoking Cessation | 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. |
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| Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines) | 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. |
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| Weight Loss | 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. |
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| Low Sodium Diet | 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. |
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| Smoking Cessation | 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. |
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| Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines) | 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. |
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This arm will target a more aggressive blood pressure target of < 120/80 mmHg. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Treatment 2 | This arm will target a more aggressive blood pressure target of < 120/80 mmHg. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline and 1 year |
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| 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. | Posted | Number | percentage of participants | Baseline and 1 year |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 65 | 0 | 65 | ||
| EG001 | Treatment 2 | This arm will target a more aggressive blood pressure target of < 120/80 mmHg. | 0 | 58 | 0 | 58 |
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Despite our best efforts, study retention was hindered by a higher than expected drop-out rate (26.0% overall; 27.7% control and 24.1% intervention).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Levy, MD | Wayne State University | 3139938558 | plevy@med.wayne.edu |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004039 | Diet, Sodium-Restricted |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| >=65 years |
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| Male |
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