Goal 2: Reduce Human Disease

Targeting Preclinical Diastolic Dysfunction to Prevent Heart Failure

Heart failure (HF) affects over 5 million American adults, and projected estimates show growth of this epidemic by 25% over the next 15 years as the population of the United States continues to age. Heart failure with preserved EF (HFpEF) encompasses 50% of all heart failure cases. Preclinical diastolic dysfunction (PDD) is defined as normal systolic function, moderate or severe diastolic dysfunction determined by Doppler ...more »

Submitted by (@chen.horng)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

There is currently no FDA approved therapy for HFpEF and yet HFpEF makes up 50% of all HF population. The prevalence of PDD (ACC/AHA Stage B HF) is abt 28% of the general population and these patients do not have symptoms of HF. Understanding the pathophysiology of PDD may leady to the development of therapeutic strategies to prevent the development of HFpEF. This would decrease the burden of HF impact public health and be cost-effective, similar to the use of vaccine to prevent infectious diseases.

Feasibility and challenges of addressing this CQ or CC :

With echocardiography, we are able to identify PDD patients before they develop symptomatic HF. Hence with research funding, we can better characterize preclinical diastolic dysfunction, and to discover further targets for this entity to prevent development of HFpEF

Name of idea submitter and other team members who worked on this idea : Horng H Chen

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Goal 2: Reduce Human Disease

Should clinical primary prevention of ASCVD be guided by subclincal disease or estimated risk?

Current approaches to guiding use of clinical primary prevention interventions, e.g., statins and aspirin, are based on treating patients who exceed a specific risk threshold. The performance of risk estimation is good, but not outstanding, and results from clinical and population studies continue to support the value of new biomarkers. Given the widespread use of preventive therapies, the lack of untreated cohorts is ...more »

Submitted by (@david.goff)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

The size of the US and global population qualifying for treatment with a statin or aspirin for primary prevention of ASCVD is immense. Given the performance of risk estimation, even if risk estimation were universally implemented, patients would be misclassified with the consequence of being under or over treated. If treatment based on presence of subclinical disease is more cost-effective, the benefits of preventive therapies can be enjoyed by larger proportions of our population and more ASCVD can be averted. Given the ionizing radiation, albeit low intensity, associated with CT scanning, it is incumbent on the biomedical research community to document the advantages, if any, of a subclinical disease guided approach to provision of clinical primary prevention services for ASCVD.

Feasibility and challenges of addressing this CQ or CC :

Many people will be concordant for the two methods of guiding provision of therapy, about 65% of middle aged and older adults. That is, many people will be high risk and have subclinical disease and many people will below risk and not have subclinical disease. It is only the discordant people, i.e., high risk people without subclinical disease and low risk people with subclinical disease, who will be informative study participants. Hence, many people will need to be screened to identify the roughly 35% who are discordant, and would be treated differently by the two approaches.

 

People may be unwilling to accept randomization once they know the information about their estimated risk and presence or absence of subclinical disease. If a low participation rate among eligible persons is observed, an even larger population of screenees would be needed.

 

A vanguard phase could provide information about these potential challenges.

Name of idea submitter and other team members who worked on this idea : David Goff, Donald Lloyd-Jones, Phil Greeland.....

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Goal 2: Reduce Human Disease

Impact of intrauterine environment on obesity

How does maternal obesity before or during pregnancy affect the intrauterine environment and increase the risk of overweight/obesity in the offspring?

How does maternal dietary intake during pregnancy impact weight in the offspring?

What types of interventions are most effective for preventing excessive gestational weight gain among high risk groups?

Submitted by (@nhlbiforumadministrator1)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

Developing effective interventions during pregnancy can help reduce the risk of obesity in the offspring and mother.

Feasibility and challenges of addressing this CQ or CC :

Addressing how the intrauterine environment impacts obesity is feasible because there is already existing preliminary data that shows pregnancy can have an impact on obesity in offspring. More work needs to be done to better understand the mechanism and how best to intervene.

There is emerging evidence that the intrauterine environment can have an impact on obesity.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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66 up votes
33 down votes
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Goal 3: Advance Translational Research

Clinical Tools for Pediatric CVD Risk Reduction and Asthma Treat

What are effective strategies and clinical decision support tools that can maximize pediatric care providers’ adoption of evidence-based recommendations for assessment and treatment of cardiovascular risk factors and/or asthma? • Clinical recommendations and associated implementation tools are often incorporated into electronic medical records (EMRs). Currently there is no standard EMR format and therefore it is difficult ...more »

Submitted by (@nhlbiforumadministrator)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

• Cardiovascular disease (CVD) remains the leading cause of death and disability in North America. There is extensive evidence documenting the initiation of the atherosclerotic process, the pathologic basis for clinical heart disease, in childhood. Additionally, asthma a chronic condition that affects more than 7 million children in the U.S. and leading to numerous emergency visits.

• Among the major factors that are associated with increased clinical recommendation use are ease of access and feasibility. A common obstacle that providers face is the availability of proper information at the point of care.

• The Community Preventive Services Task Force recommends clinical decision-support systems for prevention of cardiovascular disease based on sufficient evidence of effectiveness in improving screening for CVD risk factors and practices for CVD-related preventive care services, clinical tests, and treatments. Mobile solutions may help to further facilitate this process.

• Successful implementation of clinical recommendations for prevention and treatment of CVD pediatric risk factors and asthma could greatly reduce the number of youth moving into adulthood at increased risk for CVD and could improve health outcomes for children with asthma.

Feasibility and challenges of addressing this CQ or CC :

• Most care providers have mobile devices or computers for use in the clinical setting. There is good evidence that clinical decision support tools (and other implementation tools) can help facilitate adoption of clinical recommendation.

• It is important to test strategies in a large scale intervention that will measure clinical CVD outcomes.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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10 up votes
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Goal 2: Reduce Human Disease

Diet and prevention of cardiovascular events

In the US, what kind of diet(s) is/are best for preventing hard cardiovascular events?

Submitted by (@nhlbiforumadministrator)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

Provide an evidence base for public policy on diet.

Feasibility and challenges of addressing this CQ or CC :

The Spaniards have shown that this kind of trial is possible. We have tools and interest in place for pragmatic trials.

 

The PREDIMED trial (done in Spain) randomized ~7000 adults and found that a diet supplemented with olive oil or nuts reduced cardiovascular events compared to a "low-fat" diet. However, in Spain the Mediterranean diet is arguably the norm.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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20 up votes
12 down votes
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Goal 2: Reduce Human Disease

Addressing the population-level determinants of CVD

Atherosclerotic CVD is an epidemic disease that is determined primarily by the social and physical environments acting in part through risk factor distributions. To date most preventive efforts have been in the clinical setting, using medications for risk factors. As useful as this is, a much better solution is to deal with the behavioral contributors to risk and their social determinants, including strong destructive ...more »

Submitted by (@stephen.fortmann)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Atherosclerotic disease is largely preventable through behavior: physical activity, nutrition, absence of tobacco use. Achieving ideal risk factor levels would virtually eliminate ischemic CVD, even in genetically-susceptible individuals. The decline in CVD mortality has been in large part due to declines in risk factor levels. The current epidemic of obesity threatens to reverse these gains. It is a critical challenge to develop ways to counter the negative social and economic forces that prevent improvements in risk behaviors

Feasibility and challenges of addressing this CQ or CC :

The short-term nature of NHLBI research has limited its ability to address this overwhelming part of the CVD problem. This is the challenge. NHLBI needs new mechanisms and perhaps partnerships to discover ways to address these population-level issues. Research on how to build community coalitions to address public health policy and educational approaches to CVD prevention will require new funding mechanisms perhaps analogous to funding individual investigators rather than individual grants.

Name of idea submitter and other team members who worked on this idea : Stephen P. Fortmann

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22 up votes
15 down votes
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Goal 2: Reduce Human Disease

Restoring Balance to Stroke Prevention in Older AFib Patients

Improving Tools for Anticoagulation Decision-Making

Submitted by (@cbens0)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

AFib increases stroke risk by five-fold and doubles the risk that a stroke will result in permanent disability. While oral anticoagulation (OAC) is highly effective at reducing stroke risk, elderly patients are often under-anticoagulated. This is in part due to an under-appreciation of the stroke risk associated with AFib and the tendency of some health care professionals to prioritize perceived bleeding risk over stroke prophylaxis. Because current bleeding risk assessment tools are imperfect and largely unable to predict patients who are likely to have bleeding complications, they are often not utilized—or if used, do not truly predict which patients are at risk of a bleed. An improved bleeding risk tool is critical to improved risk assessment in the elderly. That bleeding risk tool should then be combined with the stroke risk tool for single risk stratification to streamline anticoagulation decision-making.

Feasibility and challenges of addressing this CQ or CC :

Developing effective integrated risk assessment tools is feasible only if there is consensus on the validity of the clinical information being provided. The approach to this critical challenge is two-fold. First, needed research that improves the reliability of bleeding risk assessment in the elderly should be pursued. Second, stroke and bleeding risk tools should be combined into a single risk stratification tool. This will require significant investment and focus, but the resulting bleeding risk assessment combined with the accepted CHA2DS2-VASc score, would significantly impact the 40 - 60% of patients who are currently not on an anticoagulant and are at increased risk of stroke and death.

Name of idea submitter and other team members who worked on this idea : AFib Optimal Treatment Task Force

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11 net votes
19 up votes
8 down votes
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Goal 2: Reduce Human Disease

Primary prevention statin trial in indivduals >75 years of age

Compelling question: There is insufficient randomized trial evidence for statins for primary prevention after age 75 years, as summarized in the recent 2013 ACC/AHA cholesterol guideline. T

Submitted by (@jennifergrobinson)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

The paradigm of "net benefit" introduced in this guideline cannot be applied in the absence of evidence that statins reduce ASCVD events and the adverse event rate of statins in this age group. There are likely significant differences in net benefit in subgroups of older adults as well due to competing causes of morality, comorbidities, and increase potential adverse effects on muscle function and quality of life.

Feasibility and challenges of addressing this CQ or CC :

This can be addressed in pragmatic trial design, but must include individual level randomization and placebo control to accurately assess treatment effects

Name of idea submitter and other team members who worked on this idea : Jennifer Robinson MD MPH

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Goal 2: Reduce Human Disease

Prevent the Development of COPD

What can be done to prevent the development of COPD in individuals at increased risk. Quitting smoking before the development of COPD can prevent COPD development. What can be done to prevent COPD for individuals with other identified ris factors

Submitted by (@jsullivan)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Several risk factors have been identified that identify individuals at risk for developing COPD including low birth weight, poor maximally attained lung function and the presence of asthma. Strategies to prevent COPD development in these individuals are needed.

Feasibility and challenges of addressing this CQ or CC :

The Lung Health Study demonstrated that smoking cessation prevents COPD progression. Studies of similar size and duration should be organized to address other risk factors.

Name of idea submitter and other team members who worked on this idea : COPD Foundation, COPDF MASAC

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Goal 2: Reduce Human Disease

A Program of Research in the Prevention of Chronic Heart Failure

There is a need to improve identification and surveillance of persons at risk for heart failure and pathological ventricular remodeling prior to development of clinically overt heart failure.

Submitted by (@nhlbiforumadministrator)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Substantially reduce the age-adjusted incidence and population burden of chronic heart failure.

Feasibility and challenges of addressing this CQ or CC :

The big data and omics revolutions have made it feasible to collect and analyze a variety of data in large numbers of persons within a relatively short time. A very large sample size provides excellent statistical power. Also, the public health and economic magnitude of the problem create the urgency needed to address the critical challenge expeditiously.

Chronic heart failure (HF) is easily the most common and growing cardiovascular cause of hospitalization and impaired functional status and quality of life in the U.S. and much of the world. This is the case despite improved pharmacologic and lifestyle treatment of HF, as well as improved control of blood pressure in the general population. While some HF in the very elderly may reflect the aging process, the epidemiology suggests that most incident cases could be prevented or postponed for years. Also, there are major ethnic and socioeconomic disparities in the incidence of HF.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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28 up votes
14 down votes
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Goal 3: Advance Translational Research

Impact research related to obesity interventions in black and and other high-risk populations?

How can we increase high-impact obesity and CVD-related intervention research with black and other high risk populations. Specifically, how can the NHLBI and NIH process ensure the generation of more research on solutions to weight issues that is goal-oriented and population-focused, e.g., sets of studies designed to align with a coherent, population-focused research agenda with prioritized questions based on potential ...more »

Submitted by (@skumanyi)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

The high and above-average prevalence of obesity and severe obesity among black children and adults persists, and obesity prevalence is still increasing in some age and gender subgroups in the black population. Current treatments don’t seem to work as well to reduce weight in blacks compared to whites (at least based on studies in adults), although some show promise for reduction of CVD risk factors even with modest weight loss. Preventive interventions are urgently needed but underdeveloped.

 

The context and process of intervening on weight issues differs by cultural and socioeconomic contexts. Yet, research that specifically focuses on approaches that can be effective in black population subgroups in communities at large is sparse; many studies are small, with methodological limitations. Within the overall research effort to address obesity, more studies, better studies, and coordinated studies on black Americans as a high risk sub-population could move the needle. This could be a general need related to high-risk populations who will never be the mainstream research focus and may have different contexts and needs.

Feasibility and challenges of addressing this CQ or CC :

It is feasible to do this if the challenges can be overcome and appropriate funding mechanisms are provided. The typical funding mechanisms focus on investigators rather than on populations and on disconnected R01s. The likelihood that these will add up to tell a coherent story is low. More mechanisms are needed to support coordinated studies planned to have collective impact for the black (or other) population. Other challenges are to improve methodological quality (including design, measurements, and duration), phase studies so that they can build on each other, and standardize process and outcome assessments to improve the ability to synthesize study results.

Name of idea submitter and other team members who worked on this idea : Shiriki Kumanyika and members/colleagues who are authors of a journal supplement to Obesity Reviews, October 2014

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Goal 3: Advance Translational Research

Build a National Surveillance of Chronic CV and Lung Diseases

There is a need to build a robust coordinated surveillance system on the incidence and prevalence of chronic diseases. Surveillance data are needed to: •Describe and monitor the burden, trends, and patterns of these diseases •Set parameters and metrics of research priorities •Identify where to target resources for prevention, treatment, and delivery of care •Track and monitor progress toward public health disease ...more »

Submitted by (@nhlbiforumadministrator)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

The high prevalence of chronic cardiovascular and lung diseases has created burden in increasing healthcare costs and high mortality rates in the US compared to other developed countries. Even so, they remain among the most preventable health problems. A national surveillance system for chronic cardiovascular and lung diseases would enable data-driven decision-making about public health strategies for prevention, management, and cost containment.

Feasibility and challenges of addressing this CQ or CC :

A 2011 Institute of Medicine (IOM) report concluded that a coordinated surveillance system is needed. It proposed a framework for such a system that would integrate existing information through collective efforts of multiple stakeholders. The time is right to gain from and build upon numerous ongoing broad initiatives in biomedical Big Data, including growing health IT adoption mandated by the HITECH Act, ONCHIT efforts to achieve health IT interoperability, the NIH BD2K initiative, and the multiorganizational network participating in FDA Mini-Sentinel, HCS Collaboratory, and PCORnet, among others. The NHLBI is well-positioned to lead, develop and implement the IOM’s recommended framework and system. (IOM report - http://www.iom.edu/Reports/2011/A-Nationwide-Framework-for-Surveillance-of-Cardiovascular-and-Chronic-Lung-Diseases.aspx)

Existing data sources (i.e., population surveys, registries, cohort studies, administrative data, and vital statistics) do not individually provide nationally representative data, cannot be linked, and are not currently readily accessible to all levels of users. One potential way to build such a system is to integrate and expand existing data sources.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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8 down votes
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