Short Version of Long-term Plan for Research and Translation in Hypertension for Enhancing Public Health

February 2005

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Introduction

Hypertension affects 65 million US adults, and above-optimal but non-hypertensive levels of blood pressure (BP)--now termed "pre-hypertension"-- are found in another tens of millions. The risk of developing hypertension during the remaining years of life for non-hypertensive adults aged 55 years has been estimated as 60-90%, depending on diagnostic criteria. In addition, at least two million children and adolescents have hypertension, according to current definitions. Hypertension and pre-hypertension are among the most important risk factors for coronary heart disease (CHD), stroke, heart failure, and chronic kidney disease leading to renal failure. On a worldwide basis, a World Health Organization report has estimated that about two-thirds of the burden of cerebrovascular disease and about one-half of the CHD burden are attributable to above optimal BP.

While we have learned a great deal about the etiology, prevention, and treatment of hypertension in the past 50 years, and there have been great public health gains since the National High Blood Pressure Education Program was launched by the National Heart, Lung, and Blood Institute (NHLBI) in 1972, we are clearly in need of both more knowledge and better means to apply what we know. In the U.S., after decreasing for several decades, hypertension prevalence is increasing in concert with epidemic obesity. Recently published trend analyses for children and adolescents show rising mean systolic and diastolic BP from 1988-94 through 1999-2000 as well, in part attributable to overweight that is rapidly increasing in the young. In adults, awareness, treatment, and control rates continue to improve, but control remains at only about 34%, far below national goals.

There are several significant NHLBI-sponsored/supported research and translation efforts underway, but the ability to judge their contributions is still several years away. In the interim, this report was prepared to recommend a course for the NHLBI regarding activities to be initiated over the next 5 years that may be expected to result in public health benefits within 10 years. The report consists of assessments of the current state-of-the-science and of ongoing activities in 17 topic areas, accompanied by recommendations for research initiatives and translation projects. These concepts have been developed and reviewed by NHLBI staff, then further reviewed by senior non-Federal scientists. When finalized, the report will be available to the Board of Extramural Advisors and the National Heart, Lung, and Blood Advisory Council.

Executive Summary

The purpose of this report is to recommend a course for the National Heart, Lung, and Blood Institute (NHLBI) regarding hypertension-related activities to be initiated or continued over the next 5 years that may be expected to result in public health benefits within 10 years. The report consists of assessments of the current state-of-the-science and of ongoing activities in 17 topic areas, accompanied by recommendations for research initiatives, pre-initiative planning activities, and translation projects. Its preparation was begun at the request of the former NHLBI Director, Dr. Claude Lenfant, and its completion encouraged by the Acting Director, Dr. Barbara Alving. The report represents collaborative efforts of four units of the Institute: the Divisions of Epidemiology and Clinical Applications, and of Heart and Vascular Diseases; the Office of Prevention, Education, and Control; and the National Center on Sleep Disorders Research.

The proposals for each area are listed in the Table of Proposals. Suggested priorities have been developed based on voting by the report's authors, who were requested to indicate their top five choices. Five of the listed proposals were not included in the voting: the continuation of surveillance of prevalence, awareness, treatment, and control (from the National Health and Nutrition Examination Survey) as well as of mortality, hospitalization, and drug use through existing Centers for Disease Control and Prevention/National Center for Health Statistics data systems, because these were deemed essential to continue; and the first four proposals listed under dissemination and implementation programs, as these are proceeding in any case. One other activity was also viewed as already in place, namely addressing issues of design, sample storage, and consent for pharmacogenetic studies from the onset of planning large hypertension treatment trials.

The three top choices for new activities were: 1) initiate a multi-center sodium reduction trial in infants, with long-term follow-up to investigate an "early programming" effect; 2) convene a working group to address research on chronic stress and its blood pressure effects; and 3) convene a working group to evaluate the feasibility of a trial of multi-component lifestyle and behavioral intervention, which includes stress management and cognitive approaches, to reduce the need for antihypertensive drugs. The next tier of preferences included four proposals: 1) initiate validation studies of manual and automated sphymomanometers, including determination of usefulness in populations with specific morbidities affecting measurement; 2) encourage further studies of mechanisms relating blood pressure to body mass, fat distribution, and patterns of physical activity, including race/ethnic variation; 3) develop an RFA for primary-care-based or community-based trials of simple behavioral interventions to change diet and physical activity for blood pressure reduction; and 4) institute a multi-center clinical trial to evaluate effects of lower systolic blood pressure treatment goals and compare various classes of second-step drugs for effects on CVD events. Finally, the next five choices were: 1) encourage longitudinal analysis of ongoing children's cohort studies with very long follow-up to allow risk stratification of children with high blood pressure; 2) initiate a clinical trial of individually tailored approaches to intervention on adherence to determine efficacy and applicability; 3) develop an RFA for mechanistic studies of hypertension in the young; 4) define a core of sleep-related information for collection in various NHLBI studies to test for associations with blood pressure and other factors; and 5) conduct a pilot program of educating and disseminating to health professionals patient adherence enhancing strategies for hypertension treatment and prevention that have shown to be effective.

The authors of this report have not attempted to lay out phasing of the various proposals or to estimate budgets, although there are clearly a number of low-cost activities and at least one very large one (the hypertension treatment trial). If decisions are made to develop further any element of the Plan, these tasks would fall to the involved Divisions/Office/Center. Proposals would be developed guided in some cases by the convening of Workshops/Working Groups or directly as Requests For Applications (grants or cooperative agreements), Requests For Proposals(contracts), or Program Announcements. Concept review of fully developed initiatives is customarily conducted by the Board of Extramural Advisors and the National Heart, Lung, and Blood Advisory Council. With dissemination of this Plan through the NHLBI web site, some topics may be left wholly to the interest and initiative of investigators.

Long-term Hypertension Plan

Table of Proposals

Topic

New or continuing activity

Descriptive epidemiology

-Continue surveillance of prevalence, awareness, treatment, control (via NHANES), plus hypertension-related mortality, hospitalization, and drug use.

 

-Propose additional over-sampling by race-ethnicity in NHANES.

 

-Consider cohort and surveillance studies of trends and disparities in hypertension incidence, plus related morbidity and treatment.

Pathogenesis

-Convene an expert panel on pathogenesis of hypertension: research needs for next 5-10 years. (Implemented, 5/04)

Obesity and physical activity as etiologic factors

-Encourage further studies of mechanisms relating BP to body mass, fat distribution, and patterns of physical activity, including race/ethnic variation.

 

 

-Encourage further studies of BP effects of intensity, frequency, duration, and type (aerobic/resistance) of physical activity, including interactions with degree of adiposity.

 

-Encourage studies to improve measurement of physical activity, including validation in race-ethnicity sub-groups.

Diet composition as etiologic factor

-Initiate a multi-center outpatient feeding study to identify causal components of DASH diet.

 

Psychosocial stress as etiologic factor

-Convene a working group on chronic stress and its BP effects. (Partially addressed by Working Group on CV Consequences of Chronic Stress, 6/04)

Sleep-disordered breathing as etiologic factor

-Evaluate screening tools for sleep-disordered breathing against polysomnography in observational studies.

 

 

-Define core of sleep-related information for collection in various NHLBI studies to test for associations with BP and other factors.

 

-Encourage or initiate trials lasting 1 year or longer of treatment for sleep-disordered breathing for improving hypertension control.

BP measurement: technical issues

-Initiate validation studies of manual and automated sphygmomanometers, including determination of usefulness in populations with specific morbidities affecting measurement.

 

-Coordinate one or more meetings of voluntary, professional, regulatory, and technical organizations to develop procedures for certification of sphygmomanometers, and for training and certification of BP observers.

BP measurement: behavioral issues

-Convene working group on ambulatory- and self-measurement of BP in diagnosis, monitoring, and treatment of hypertension.

Prevention/lifestyle treatment in children

-Encourage randomized trials of weight control and BP.

 

-Initiate collaborative feeding studies of dietary patterns and reduction of dietary salt and BP.

 

-Initiate a multi-center sodium reduction trial in infants, with long-term follow-up to investigate "early programming" effect.

 

-Develop RFA on mechanistic studies of hypertension in the young.

Prevention/lifestyle treatment in adults

-Develop an RFA for primary-care-based or community-based trials of simple behavioral interventions to change diet and physical activity for BP reduction.

 

-Evaluate feasibility of conducting a trial of a multi-component lifestyle and behavioral intervention, which includes stress management and cognitive approaches, to reduce need for drugs.

 

-Develop an RFA to evaluate environmental interventions to modify physical activity opportunities and/or sales and consumption of foods and nutrients that affect BP.

Drug treatment in adults

-Initiate a multi-center clinical trial to evaluate effects of lower systolic BP treatment goals and compare various classes of second-step drugs for effects on CVD clinical events.

Pharmacogenetics

-From the onset of planning large hypertension treatment trials, address issues of design, sample storage, and consent for pharmacogenetic studies.

Chronic hypertension in pregnancy

-Consider initiating a randomized trial of antihypertensive drug treatment with assessment of BP control, fetal safety, and genetic variation in response.

Drug treatment in children

-Consider initiating long-term safety and efficacy studies.

 

-Encourage longitudinal analysis of children's cohort studies with very long follow-up to allow risk stratification of children with high blood pressure.

Patient adherence

-Initiate a clinical trial of individually-tailored approaches to adherence intervention to determine efficacy and applicability.

 

-Develop an RFA or PA to encourage development and testing of practical strategies and simple tools to measure adherence in research, patient care, and community settings.

 

-Develop an RFA or PA to further understanding of effects on adherence of various antihypertensive medication formulations, particularly advantages/disadvantages of combination pills.

 

-If successful adherence methods are found in studies funded under the RFA "Overcoming Barriers to Treatment Adherence in Minorities and Persons Living in Poverty", design a follow-up RFA to test approaches for disseminating/integrating these methods into various health care settings.

Clinical practice

-Develop an RFA to support randomized trials to evaluate cost-effective strategies for changing clinical practice toward better BP control and better selection of treatment modalities.

Dissemination and implementation programs

-Convene a working group to revise previous guidelines on high blood pressure in children and adolescents. (completed 5/04)

 

-Develop new web site materials for HBP Education Month, 2004, addressing population-based approaches for primary prevention of hypertension, reinforcement for treated patients to stay on therapy, and other objectives.

 

-Form a small working committee with the National Committee on Quality Assurance to review the HEDIS hypertension measure, and determine if it can be lowered.

 

-Work with the American Heart Association Working Group on Blood Pressure Measurement on updating recommendations. (Published, 1/05)

 

-Consider a pilot program of educating and disseminating to health professionals patient adherence enhancing strategies for hypertension treatment and prevention.



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