Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients

NCT00689819 | Completed Results DMC

• 1 other identifier: 0803305872
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hypertension; High blood pressure; Pre-clinical cardiac dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Prevalence of PCCD

  Baseline and 1 year

Study Arms (2)

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.

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)

BP < 120/80 mmHg

EXPERIMENTAL

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

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)

Interventions

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.

BP < 140/90 mmHg

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.

BP < 140/90 mmHg

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.

BP < 140/90 mmHg

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.

BP < 140/90 mmHg

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.

BP < 140/90 mmHg

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Blood pressure \> or = 140/90 after 1 hour
• Asymptomatic state as defined by Goldman Specific Activity Scale

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wayne State University: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• 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.

  PMID: 32622346 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Exercise; Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

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).

Results Point of Contact

• Title: Phillip Levy, MD
• Organization: Wayne State University

plevy@med.wayne.edu

3139938558

Study Officials

• Phillip D. Levy, M.D., M.P.H.

  Wayne State University Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 4, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 3, 2013
• Results First Posted: November 5, 2013

Record last verified: 2013-11

Locations

US (1)