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 2: Reduce Human Disease

Improving pre-hospital therapy of HLB disorders

There is compelling evidence that pre-hospital therapy of both stroke and MI can improve outcomes and yet, with the exception of aspirin for MI, almost no care is administered pre-hospital in the U.S. NHLBI has a major stake in improving pre-hospital care because there already are sufficient data to show that currently available interventions would improve outcomes if they could be administered in the prehospital setting. ...more »

Submitted by (@collerb)

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 mortality and disability from stroke could be substantially reduced. The early mortality of STEMI and late disability from heart failure could be substantially reduced.

Feasibility and challenges of addressing this CQ or CC :

There are numerous challenges including:

• Obtaining informed consent for pre-hospital clinical trials

• Fragmentation of EMS services by locale

• Need to train EMS personnel

• CMS rules on reimbursement for ambulance services and novel drugs

 

NHLBI could use its convening power in partnership with other groups to integrate this effort.

Name of idea submitter and other team members who worked on this idea : Barry Coller

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Goal 3: Advance Translational Research

Generalizing patient education to address co-morbidities

How do we generalize our educational efforts such that multiple co-morbidities and their self-care can be addressed?

Submitted by (@kdeit1946)

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

Details on the impact of addressing this CQ or CC :

Patients with with many co-morbidities, many times have to weigh the benefits of a particular medication for one issue, with the downside of what it may do to another issue. There needs to be much more education in this area.

Name of idea submitter and other team members who worked on this idea : Karen Deitemeyer, COPD Foundation State Captain Program

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Goal 2: Reduce Human Disease

Measuring and Improving Physical Fitness to improve outcomes after Hematopoietic Stem Cell Transplantation

Can cardiorespiratory fitness prior to hematopoietic cell transplantation be improved and will this limit morbidity and mortality following transplantation?

Submitted by (@sheat0)

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

Details on the impact of addressing this CQ or CC :

HCT is associated with high rates of morbidity and mortality from transplant-related complications, the reduction of which would lead to higher transplant-mediated cure rates for life-threatening benign and malignant hematologic disorders. Comorbidity and patient-reported functional status impairment are known to increase the risk for transplant-related mortality, but unlike comorbidity, cardiorespiratory fitness is potentially modifiable. The optimal way to improve fitness through pre-transplant exercise and lifestyle interventions is not known, however, and understanding how to affect through a short term intervention would also benefit other cancer and non-cancer health conditions in which future treatment is intensive and associated with significant risk.

Feasibility and challenges of addressing this CQ or CC :

Feasibility and Challenges of Addressing the CG or CC:

 

Understanding how to improve cardiorespiratory fitness in a short period of time will require a research agenda that addresses the following challenges: how to measure cardiorespiratory fitness in a generalized and scalable way, which may or may not require maximal exercise testing for all participants; how to design intensive exercise interventions that are at least partially home-based in order to minimize resource burden on patients and centers; and how to personalize intervention delivery and testing in a way that is tailored to the baseline fitness levels and capabilities of each participant. Meeting these challenges will enable large-scale, personalized exercise testing and intervention delivery in other non-transplant populations.

Name of idea submitter and other team members who worked on this idea : Thomas Shea and William Wood

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Goal 2: Reduce Human Disease

The Importance of the Microbiome in Recovery after Hematopoietic Stem Cell Transplantation

Do modifications in the recipient gut or lung microbiome affect development of tolerance and immunologic recovery after allogeneic hematopoietic stem cell transplantation (HCT) and can re-institution of a more normal microbiome lead to improved outcomes?

Submitted by (@marymh)

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

Details on the impact of addressing this CQ or CC :

HCT leads to profound changes in the host microbiome. Some small studies indicate that differential recovery of the gut microbiome is associated with differential outcomes, including graft-versus-host disease and mortality. Less is known about the pulmonary microbiome. Better understanding of the role of the microbiome in facilitating posttransplant recovery could lead to easily administered interventions and provide important insights into the role of different subpopulations of the microbiome on the health of all people.

Feasibility and challenges of addressing this CQ or CC :

Preclinical and clinical studies of this area would be greatly facilitated by a microbiome repository linked to high quality clinical data and would provide opportunity for insight into the role of the microbiome in health and disease.

Name of idea submitter and other team members who worked on this idea : Mary Horowitz

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Goal 3: Advance Translational Research

The Designation of Human Cardiac Stem Cell therapy Products for Human Trials or First-in-Human Studies

For successful pharmaceutical development of cardiac stem cell therapy, the human cardiac stem cell therapy product must meet certain commercial criteria in plasticity, specificity, and stability before entry into clinical trials.

Submitted by (@xuejunparsons)

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

Details on the impact of addressing this CQ or CC :

For successful pharmaceutical development of cardiac stem cell therapy, the human cardiac stem cell therapy product must meet certain commercial criteria in plasticity, specificity, and stability before entry into clinical trials. Moving stem cell research from current studies in animals into human trials must address such practical issues for commercial and therapeutic uses: 1) such human stem cells or their cardiac derivatives must be able to be manufactured in a commercial scale; 2) such human stem cells and their cardiac derivatives must be able to retain their normality or stability for a long term; and 3) such human stem cells must be able to differentiate or generate a sufficient number of functional or contractile cardiomyocytes for repair. Those practical issues are essential for designating any human cardiac stem cells as a human cardiac stem cell therapy product for investigational new drug (IND)-filing and entry into clinical trials. So far, the therapeutic effects, if any, of human cardiac stem cells in the existing market, including those derived from patients’ heart tissues, were mediated by protective or tropic mechanism to rescue dying host cardiomyocytes, but not related to myocardium regeneration.

Feasibility and challenges of addressing this CQ or CC :

Opportunity: Recent breakthrough stem cell technologies have demonstrated the direct pharmacologic utility and capacity of pluripotent human embryonic stem cell (hESC) therapy derivatives for human CNS and myocardium regeneration and, thus, have presented the hESC cell therapy derivatives as a powerful pharmacologic agent of cellular entity for a wide range of CNS and heart diseases. The hESC cardiomyocyte cell therapy derivatives by novel small molecule induction provide a large scale of high quality human cardiomyocyte source for myocardium regeneration and, thus, meet the designation of human stem cell therapy products in plasticity, specificity, and stability for commercial development and human trials or first-in-human studies in cardiovascular diseases.

Name of idea submitter and other team members who worked on this idea : Xuejun Parsons

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Goal 3: Advance Translational Research

Halt the Epidemic of Atrial Fibrillation

Effective approaches are needed to halt the epidemic of atrial fibrillation (AF) and its associated morbidity.

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 :

Reduce the almost epidemic increase in the occurrence of AF in the aging U.S. population. This is a critical need for which basic science and clinical tools presently exist to address and resolve into a means to reduce the clinical consequences of AF.

Feasibility and challenges of addressing this CQ or CC :

To accomplish this goal the following approaches could be taken:

GENETIC: Investigate genetic factors that drive susceptibility to atrial fibrillation in various disease states and “lone” AF.

BASIC: Investigate the principles underlying electrical and structural remodeling which facilitate and perpetuate atrial fibrillation. Use a systems approach to aid the understanding of the role of neurohormonal and other organ system influences on human cardiac electromechanical activity. Develop new imaging modalities to better characterize conduction abnormalities in three dimensions. Investigate the nature of chamber-specific channels as potential targets for AF therapies. Encourage the development of new thrombin inhibitors and other potent but safe anticoagulants.

TRANSLATIONAL: Investigate promising pharmacologic or other interventions designed to reduce the incidence of atrial fibrillation in animal models with spontaneously occurring atrial fibrillation. Create the infrastructure for a “dynamic repository” of clinically obtained fresh human cardiac tissue for the study of AF.

CLINICAL: Improve the collection of atrial fibrillation as an endpoint in large phenotyped cohorts. Evaluate the safety and efficacy of ablative procedures relative to appropriate pharmacologic therapies. Evaluate interventions which may prevent first development and recurrence of AF (statins, ACE-I/ARB, beta blockers). Investigate the use of new antiplatelet thienopyridines for stroke prevention in AF.

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

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13 up votes
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Goal 2: Reduce Human Disease

Gene Therapy for Rare Lung Diseases

Accelerating the research to find suitable viral vectors and delivery systems to inhale gene therapy deeply into the lungs. Distal therapy is important for several fatal lung diseases. This is urgent and critical research.

Submitted by (@dappell)

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

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Goal 1: Promote Human Health

Rife Frequency Treatment

Ray Rife produced lists of frequencies, most within the sound spectrum that would cause viruses to resonate, explode and die. Do you have any ongoing research or use of his system?

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 :

Cures for many diseases, especially Cancer.

Feasibility and challenges of addressing this CQ or CC :

I have already built a simple, working system.

Name of idea submitter and other team members who worked on this idea : Joseph C. Mullally

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Goal 2: Reduce Human Disease

Thrombprophylaxis in cancer patients

What is needed to identify the cancer patients that would benefit from thromboprophylaxis and the agents that should be used?

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 :

The close relationship between cancer and thrombosis has been known since the days of Armand Trousseau, who first described the clinical association between idiopathic venous thromboembolism (VTE) and occult malignancy in 1865. Today, we know that some cancers are associated with a hypercoagulable state and up to four-fold increase in thrombosis risk, with chemotherapy elevating this risk even more. Thrombosis has a significant impact on the morbidity and mortality of cancer; therefore, it is important to identify which patients may be at higher risk than others, especially before starting chemo-radiotherapy or surgery. However, there is no standard of care for thromboprophylaxis in cancer patients. Identification specific groups of risk for thrombosis and appropriate anticoagulation regimen, especially in mid-level risk groups, would provide direct benefit to the outcome in cancer patients.

Feasibility and challenges of addressing this CQ or CC :

Epidemiologic and population-based studies provide detailed information on the scale of the problem and the identification of VTE risk factors, including those related to the tumor (tumor type, clinical stage, chemotherapy, use of anti-angiogenic drugs or erythropoietic growth factors, and insertion of central venous catheters), and those related to individual patient characteristics (sex, race, age, previous VTE history, immobilization, and obesity). Additional factors and biomarkers of thrombosis have been established in recent years. A new generation of oral anticoagulants that potentially can make thromboprophylaxis in cancer patients safer and easier, has been developed. All these achievements may transform the current empirical nature of anticoagulants use in cancer to scientifically justified, efficient and safe thromboprophylaxis.

 

 

 

While there is a clear progress in our understanding of the mechanisms associated with the development of malignancy, we know little of the mechanisms of cancer-related thrombosis. There is evident lack of collaboration between basic scientists and clinical oncologists, which would be required for natural history and biomarker studies. Efficient collaboration is required between National Cancer Institute and National Heart, Lung, and Blood Institute to coordinate efforts and leverage resources in addressing this important research and clinical challenge.

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

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Goal 2: Reduce Human Disease

Reducing CV events in breast cancer survivors -knowledge gaps

Identifying breast cancer survivors at high risk for CV morbidity and mortality to allow targeting of management strategies to reduce CV events and thereby improve overall cancer-related survival.

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 :

Chemotherapy for breast cancer stages I-III is known to be associated with or induce cardiotoxicity. Over 35% of these women develop progressive fatigue and exercise intolerance, and heart failure limiting their daily activities and frequently interfering with their ability to return to work. CV disease are the leading cause of morbidity and mortality for those surviving beyond 5 to 8 years from their breast cancer diagnosis. The excess of CV morbidity and mortality in these patients threatens to offset reductions in cancer-related survival. Identifying breast cancer survivors at high risk for CV morbidity and mortality could allow targeting of cardiovascular disease reducing therapeutic interventions.

Feasibility and challenges of addressing this CQ or CC :

creating a multisite registry of women with Stage 1-3 breast cancer scheduled to receive chemotherapy and a control population women of similar demographic and CV risk profile without neoplasia, would allow to collect data at baseline and during/after cancer treatment related modern therapy, pre/post treatment functional status, including fatigue, behavioral and psychosocial risk factors and quality of life, and serum biomarkers indicative of myocardial injury, fibrosis, and heart failure.

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

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Goal 3: Advance Translational Research

Develop common-sense standards for obesity research

Obesity research is riddled with methodological problems that are rarely challenged, leading to the perpetuation of misinformation and interventions that do harm. Given the two-thirds of the population who are classified as higher weight and thus subject to these interventions, it is past time to clean up the basic scientific flaws in this research area. For a quick summary of a couple of these issues, see Poodle Science: ...more »

Submitted by (@dbdb00)

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

Details on the impact of addressing this CQ or CC :

This subject really is both CG and CC. The CQ aspect is to see past the weight bias and stigma we are all subject to in order to see diversity of weight as normal, even as people across the weight spectrum suffer health insults from sources that are rarely investigated within the medical model (cf social determinants of health). The CC aspect is the enormous economic and cultural pressures to maintain the valuing of some bodies over others in order to sell products and create a group of people who have fewer ways to defend themselves from oppression.

Feasibility and challenges of addressing this CQ or CC :

Several key areas could make a big difference and they are quite feasible.

1. Require researchers to have studied weight bias and stigma so they are more aware of their own potential proclivities to frame research questions or results according to the status quo.

2. Require any study that claims a weight loss finding to have, report, and publish followup data on all participants at least 2-5 years post-intervention.

3. Require any study claiming a health issue related to weight to compare not higher and lower weight people, but rather higher weight people who have pursued weight loss and higher weight people who have not, since there is no way for higher weight people to be always-been-thinner.

4. Require weight/health research to control for obvious confounders such as weight cycling, SES, exposure to weight stigma, exposure to weight discrimination, exposure to racism, exposure to stress, lack of access to unbiased medical care, etc.

5. Require that journals allowing statements in the abstract or discussion or conclusions that generalize beyond the data be accountable, and that journals provide an accurate translation of the findings for journalists complete with statements about limitations of findings and possible alternative interpretations.

6. Fund projects which are about listening, especially to people who are rarely asked about their lived experience, in order to generate better research that actually improves quality of life for higher-weight people.

Name of idea submitter and other team members who worked on this idea : Deb Burgard, PhD

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