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临床试验/NCT00689819
NCT00689819已完成不适用

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?

Wayne State University1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
123
试验地点
1
主要终点
Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: Exercise (Behavioral)

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.

干预措施: Weight Loss (Behavioral)

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.

干预措施: Low Sodium Diet (Behavioral)

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.

干预措施: Smoking Cessation (Behavioral)

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.

干预措施: Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines) (Drug)

BP < 120/80 mmHg

Experimental

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

干预措施: Exercise (Behavioral)

BP < 120/80 mmHg

Experimental

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

干预措施: Weight Loss (Behavioral)

BP < 120/80 mmHg

Experimental

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

干预措施: Low Sodium Diet (Behavioral)

BP < 120/80 mmHg

Experimental

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

干预措施: Smoking Cessation (Behavioral)

BP < 120/80 mmHg

Experimental

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

干预措施: Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines) (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Change in Prevalence of PCCD(Baseline and 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phillip D. Levy

Research Investigator

Wayne State University

研究点 (1)

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