Highlights of the week:
REPRIEVE Study Stopped Early for Efficacy
A National Institutes of Health (NIH) clinical trial was stopped early because a daily statin medication was found to reduce the increased risk of cardiovascular disease among people living with HIV in the first large-scale clinical study to test a primary cardiovascular prevention strategy in this population. A planned interim analysis of data from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study found that participants who took pitavastatin calcium, a daily statin, lowered their risk of major adverse cardiovascular events by 35% compared with those receiving a placebo. Adverse drug events observed in the study were like those in the general population taking statin therapy. The interim analysis was sufficiently compelling that the study’s independent Data Safety and Monitoring Board (DSMB) recommended it be stopped early given adequate evidence of efficacy. The NIH accepted the DSMB recommendations.
REPRIEVE began in 2015 and enrolled 7,769 volunteers who were 40 to 75 years of age, of whom more than 30% were women. REPRIEVE volunteers were all taking antiretroviral therapy, with CD4+ cell counts greater than 100 cells/mm3 of blood at enrollment, and had low-to-moderate traditional cardiovascular disease risk that would not typically be considered for statin treatment. The trial was conducted in 12 countries in Asia, Europe, North America, South America and Africa.
The REPRIEVE study is primarily supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung and Blood Institute (NHLBI) with additional funding from the NIH Office of AIDS Research. The study was conducted by the AIDS Clinical Trials Group (ACTG).
Decades of research and advances in HIV treatment have drastically reduced AIDS-related complications and deaths. As people with HIV live longer, premature heart disease and other chronic conditions have emerged as leading causes of morbidity and mortality, contributing to persistent gaps in lifespan between people with HIV and the broader population.
“The epidemiologic evidence is that there’s about twice the risk of heart disease in people with HIV than there are in non-infected people with the same level of traditional, normal type risk factors, said Pamela S. Douglas, MD, the Ursula Geller 
Professor of Research in Cardiovascular Diseases at Duke and a co-principal investigator of the Clinical Coordinating Center. “So, there’s something else that’s contributing to their heart disease. This is a population that we would never have normally, under current practice, thought about putting on a cardiac prevention medication because we wouldn’t think of it as being effective. Initial findings showed that yes, the pills were effective in lowering LDL, so they did what they were supposed to do – but the magnitude of the benefit from the statin is twice as great as one would expect from lowering the LDL cholesterol.”
Statins are a class of medicines routinely prescribed to lower cholesterol and are known to prevent cardiovascular disease in those at risk in the general population. It was not clear if statins would have the same effect in people living with HIV and who have premature cardiovascular disease despite having low-to-moderate traditional risk. In the REPRIEVE trial, participants were randomly assigned to receive a daily dose of 4 mg of pitavastatin or placebo. They were monitored for major adverse cardiovascular events and adverse reactions to pitavastatin, which is considered safe for use with all prescribed antiretroviral therapy regimens.
The study’s DSMB met at planned intervals throughout the study to review safety and efficacy data. In its most recent meeting, the DSMB determined that the benefits of daily pitavastatin use outweighed any risks and recommended that the study terminate early, and that a full data collection be conducted across sites for final analysis. Study participants are being notified of the findings and will continue to be monitored for several months. Study results from the DSMB review are expected to be published in the coming weeks.
“These latest findings represent the culmination of an unprecedented eight-year effort to generate evidence that can help clinicians better support the unique cardiovascular health needs of people living with HIV,” said NHLBI Director Gary H. Gibbons, MD “REPRIEVE is important because there are limited existing interventions to help prevent adverse cardiovascular outcomes in this population.”
The REPRIEVE study was funded by a grant to the Massachusetts General Hospital and led by Steven Grinspoon, MD, professor of medicine at Harvard University, endowed chair in Neuroendocrinology and Metabolism and chief of the metabolism unit at Massachusetts General Hospital, who directed the study’s Clinical Coordinating Center. Pamela Douglas, MD, the Ursula Geller Professor of Research in Cardiovascular Diseases in the Duke University Department of Medicine, was co-principal investigator of the Clinical Coordinating Center.
Michael T. Lu, MD, co-director of the Massachusetts General Hospital Cardiovascular Imaging Research Center, and Heather Ribaudo, PhD, a principal research scientist at the Center for Biostatistics in AIDS Research and the Department of Biostatistics at Harvard University, served as leads of the REPRIEVE study’s Data Coordinating Center. The study was conducted by the NIAID-funded ACTG. Additional implementation support was provided by the London-based NEAT ID Foundation, Kowa Pharmaceuticals America, Inc., Gilead Sciences, Inc. and Viiv Healthcare.
D’Amico Receives Surgeon of the Year Award from the TBJ
We are very excited to share that thoracic surgeon Thomas A. D’Amico, MD was awarded Surgeon of the Year by the Triangle Business Journal (TBJ). He was one of 14 honorees recognized on Thursday, April 13 during the TBJ’s 2023 Health Care Leadership Awards dinner. D’Amico, the Gary Hock Endowed Professor of Surgery and a faculty member within Duke’s Division of Cardiovascular and Thoracic Surgery, was one of four award winners from across Duke University Health System.
This is a very well-deserved honor. Please join us in congratulating him when you see him. Congratulations, Tommy! A link to a PDF of the news story appears below, under News.
Ross Receives AHA Career Development Award
Congratulations to Leanna Ross, a newly appointed medical instructor in the division of cardiology and a member of the Duke Molecular Physiology Institute (DMPI) – she has received a Career Development Award from the American Heart Association (AHA). The three-year award, which began April 1, is for her project, “A Precision Health Approach to Target Exercise Interventions for Short- and Long-term Cardiometabolic Health Benefits”
Ross has been at Duke since 2017 when she arrived as a postdoc. Her primary mentor since then has been cardiologist William Kraus, MD, the principal investigator on the STRRIDE research clinical trials, which were seminal to the field of exercise science and to overall understanding of the effects of exercise on health.
“The STRRIDE trials were really the first of what we call dose-response exercise trials that were able to truly compare, for example, a moderate amount of aerobic exercise versus a vigorous amount of exercise, and that if you keep the amount constant, you can actually isolate the intensity effects,” Ross says as she described the background inspiration for her project. “These trials really focused on cardiometabolic health outcomes and because of these studies, we were inspired to complete 10-year observational follow-up of the participants that were originally in the STRRIDE trials. These observations are what we call the STRRIDE Reunion studies.”
The first of the Reunion studies was completed before Ross came to Duke, but she arrived in time to help in the analysis of the data and getting the first several STRRIDE Reunion papers published. Ross and the team saw that, among the Reunion participants, there were lasting cardiometabolic and fitness health effects 10 years later for those who participated in an exercise group, compared to those that didn’t do any exercise at all, that had been in the inactive control group.
“I can’t say enough about how incredible this study is, even though it might seem like the testing we’re doing is pretty simple follow-up testing and that it’s just an observational study,” Ross adds. “The interactions and the results that we’re getting from it, I think, are going to have huge implications not just for clinical purposes, but also from a public health perspective.
“Most of our nation is physically inactive, but if you can get them to exercise in their midlife for, say, a concentrated period of time and they then have lasting health effects, we may see real impacts from the individual to public health and to medical expenditure costs within the cardiometabolic disease space.”
In terms of the AHA Career Development Award, Ross says she was drawn to apply because of her recent transition from a postdoctoral position into a faculty position and thinking about ways to further her growth, as well as some early involvement in AHA committee work.
“In order to be a leading clinical trialist in my field of exercise, physiology, and cardiometabolic health, there really are so many other skills that I want to learn. One of those is developing a better appreciation for more sophisticated bioinformatics and health data science approaches that we can apply to our clinical trial data to get a better understanding of what’s truly causing exercise to have these long-lasting effects. Then, determining if we can utilize that information and distill it towards what I’m really interested in — which is can we more precisely prescribe a certain exercise intervention for a certain person with a certain health condition and maximize their probability that they’re going to see an improvement in whatever that health factor is for them?”
The career development award is the perfect avenue for her project, she says, because it allows for a mentor training plan in addition to the research plan proposal. She’ll continue to work with Kraus as her primary mentor, but is adding Constantin Aliferis, MD, PhD and Sisi Ma, PhD, of the University of Minnesota’s Institute for Health Informatics as secondary mentors. Ross describes both Aliferis and Ma as “insanely talented,” and of Kraus she says, “I don’t even know all the words that could describe how amazing he is as a mentor.”
“I am so blessed to have this award. It’s indescribable how honored and happy I feel about how this will help me hone these skills and really get my research underway.”
Ross currently serves as the chair of the Early Career Committee for the AHA’s Lifestyle Council. She gives a lot of credit to the AHA for the value they place on early career investigators.
“It’s really amazing to me how much they’re valuing early career investigators like myself and trying to get them involved in all aspects of the AHA – from research awards to moderating presentations and being a part of scientific statements – all kinds of ways that can help foster new connections and networking, and give us those opportunities that I think traditionally were reserved for more senior faculty. This has been an incredible experience for me to become involved with the AHA at such an early stage of my career.”
In thinking about her research and career goals, Ross adds that she wants even more people to understand the power and value of exercise. “It gets complicated when we think about what we call ‘exercise prescriptions’ because there are different amounts, intensities, modes, and durations of exercise programs. We are working to be able to tailor and target those a little bit better for certain people and populations. But overall, the value of exercise and physical activity can just do wonders for not only primordial and primary prevention, but also for secondary prevention.”
To learn more about the work Ross, Kraus and others on their team are doing, you can check the DMPI website for additional information. For those interested in participating or referring patients to a future study, you can learn more about what is available here: Duke Health and Exercise Research Trials.
Ross also welcomes interested parties to contact her via email if you’re interested in learning more about the work or if interested in future collaborations. Also available on the DMPI webpage, is information about the Human Physiology Testing Core section with links to an overview of the types of testing and services the team provides.
Finally, if anyone would like to check out publications from the first STRRIDE Reunion study, here are links to two of the publications: https://doi.org/10.3389/fphys.2019.00452 and https://doi.org/10.1161/JAHA.119.012876.
Congratulations, Leanna! We’re excited to follow the work you’re doing!
Patel Featured by AHA
As the AHA leads up to its annual National Volunteer Awards event in June, they are issuing features on each of the award winners. This past week was Manesh Patel’s turn to be highlighted – their piece, 2023 AHA Physician of the Year followed his dream of making a difference is a wonderful overview of what drives Patel in his passion for cardiovascular care.
Shout-out to Burkett!
Melissa Burkett received some terrific feedback via the Press Ganey survey system. A happy patient wrote, “Melissa is phenomenal – she is very knowledgeable and was well prepared for our session – it made the session very valuable!”
“Amazing job, Melissa – thank you!!!!!” — Jamie Hilton, Nurse Manager, Operations, Clinic 2F/2G
“Melissa is a truly amazing provider and individual. Melissa, kudos for all you do to make Duke a great place for patients, families and other staff.” — Jill Engel, Service Line VP, Duke Heart & Vascular
Great Catch, Lennon!
Zachary Lennon, ACNP, 7 West, received a Great Catch this week.
Lennon noticed that an IV anticoagulant with a very short half-life had been turned off prior to administration of the oral anticoagulant that the patient was bridging to, and immediately ensured that the IV anticoagulant was re-started. His quick action ensured that the patient remained appropriately anticoagulated, possibly preventing re-occlusion of a recently placed coronary artery stent.
“As some of you know, Zach’s actions prevented a potential repeated medication related sentinel event involving transition from cangrelor to Plavix,” wrote Kara Lyven in a note to colleagues. “Zach had to be reminded of his great catch — which demonstrates his humility and how diligent he is every day — noting that this catch was ‘just’ part of his normal every day work!”
Lynn McGugan added, “Zack is always doing a great job and this is just one instance where someone reported it! Glad he works with us in the CTICU.”
Way to go, Zack!
NDLM Spirit Week Celebrated by Cardiopulmonary Rehab Team
Members of the Duke Heart cardiopulmonary team hosted an awareness table at their clinic on Hillandale Rd. in order to celebrate Spirit Week as part of National Donate Life Month (NDLM). The team shared the Donate Life message by educating others about how signing up to become an organ donor can help save lives, and helped celebrate donor recipients in the process.
Donate Life America takes the lead on NDLM, an observance that aims to focus our national attention on the need for and importance of organ, eye and tissue donation. Living Donor Day was celebrated on April 5 and the Donate Life Blue & Green Spirit Week was April 8-14.
Great job, Rehab team!!
Scheyer Featured Speaker at Upcoming DCRI Research Forum
The Duke Clinical Research Institute will hold a Research Forum on April 25, featuring a fireside chat with Duke Men’s Basketball head coach Jon Scheyer. The DCRI team is looking forward to hosting Coach Scheyer virtually to discuss his journey and the philosophy that keeps him focused on success — both his personal success and the success of his team. They will also address how his philosophy and resilience translates to healthcare and the DCRI’s approach to enhancing human health.
DCRI Research Forum: A Conversation with Duke Men’s Basketball Head Coach Jon Scheyer
Tuesday, April 25 from Noon-1 p.m. EST
Zoom Link: DCRI Research Forum
This event is open to all interested faculty, staff, and students.
Next weekend: NC Walk for Victory!
Please help Duke Heart in supporting patients with Marfan and other connective tissue disorders by supporting our efforts with the upcoming 2023 NC Walk for Victory.
The 2023 NC Walk for Victory will take place Saturday, April 22 from Noon-3 p.m. at Laurel Hills Park, 3808 Edwards Mill Rd., Raleigh (27612). Duke Heart is serving as the presenting sponsor, with Dr. Chad Hughes serving as the Walk’s Medical Director.
This event is held to gather patients, family members and friends who are affected by genetic aortic and vascular conditions, including Marfan Syndrome, Loeys-Dietz, and Vascular Ehlers-Danlos syndromes. Attendees come from all over the southeast region of the U.S. to celebrate one another and to forge friendships with others going through similar experiences.
The Walk for Victory is a fun, family-friendly event that recognizes an incredible group of people and their caregivers. The Walk helps to create awareness in the community, and is one way the Marfan Foundation raises funding for much-needed research into these genetic conditions.
It is not too late to support Duke Heart’s Duke Aorta team captain Melissa Burkett! Check out Duke Aorta’s team fundraising page for The Marfan Foundation: https://give.marfan.org/team/482581). Every donation will help!
To learn more about the event or the Marfan Foundation in general, please visit: https://duke.is/pkjnw. Thank you!
Better Together: A Culture Campaign
With so much change on the horizon for Duke Health, we have a once-in-an-era opportunity to define who we are for a new chapter, taking the best of our past and adding new ways to our future to become better together. What does it mean to become better together? It means defining our culture — who and how we want to be. We’ll look at ourselves in the mirror, keep what we like, and intentionally set aside the rest, designing a new path where everyone feels heard, valued, seen, and respected. Watch this short video to learn more.
Now is the time to act by sharing what you would keep that is good and what you would change about Duke Health. You can use this link to answer questions online, 24/7 through Tuesday, April 18.
Click here for a fact sheet to learn more.
Quick Reminders & Updates
- In light of the decreased community incidence of Covid-19 infections and a robust supply of PPE, DUHS is preparing to move to Tier 1 status. Stay tuned for updates on timing.
- The Dept. of Surgery announced last week that starting tomorrow, April 17, asymptomatic perioperative patients who have not been exposed to Covid will no longer be required to have a preoperative Covid nucleic acid assay test.
- Please participate in the Better Together online questionnaire by April 18. Link above.
Upcoming Events & Opportunities
Cardiology Grand Rounds
April 18: Genetic Cardiomyopathies and Heart Failure: Back to Bases with Karen Rosario. 5 p.m., Zoom only.
April 25: Regulatory Guidance for Cardiovascular Outcomes Trials of Antihyperglycemic Agents: Connecting the Past with the Future with Darren K. McGuire, University of Texas Southwestern Medical Center & Parkland Health and Hospital System; Deputy Editor, Circulation. 5 p.m., DN 2002 and via Zoom.
ICYMI: Links to Recent CGRs
April 4: Matt Carlisle of Duke Health presentation, Atrial Fibrillation: Contemporary Management of a Common Arrhythmia. https://duke.is/ytg6n
Final Day of Dean’s Research Series This Week
The final day of the Dean’s Research Series will be Thursday, April 20. Full schedule and details can be found at medschool.duke.edu/research-series. The Zoom link for all faculty lectures is https://bit.ly/Duke-DDRS.
The Duke University School of Medicine’s Dean’s Distinguished Research Series showcases groundbreaking research from the basic, clinical, and translational sciences. All faculty, staff, trainees and students are welcome to attend.
April 28: DOM Research Day
The Duke Department of Medicine will hold their inaugural Research Day on Friday, April 28, 2023, at the Trent Semans Center in the Great Hall from 8 a.m. until 1:30 p.m.
This event is for all departmental faculty, clinical and postdoctoral fellows, residents, medical students, and research staff. Lunch is included. For questions regarding Research Day contact Saini Pillai, MBA. A copy of the agenda can be found here.
Sudarshan Rajagopal, MD, PhD, associate professor of cardiology and a PI in the Duke Cardiovascular Research Center is one of four presenters during the faculty speaker session. Rajagopal will discuss recent research from his lab that demonstrates new modes of signaling by receptors and its potential impact on drug development.
Funding Opportunity: The Mario Family Foundation Award
Training the next generation of biomedical researchers is an important core mission of the Department of Medicine. We admit the most promising, dedicated fellows into our programs, and provide experiences that will allow them to put their passion for medicine to work. These fellows will be tomorrow’s leaders in science and medicine. The Mario Family Foundation has generously supported this mission to support junior investigators in training to make the transition to become independent scientists and planning for their first extra-mural funding.
The Department of Medicine is accepting applications from fellows in specialty training for the Mario Family Foundation Award, which funds two patient-oriented research (clinical or translational) proposals for one year of funding. The total funding for all proposal expenses is $35,000.
Applications must be submitted electronically no later than Monday, May 1, 2023, 5p.m.
Applications will be peer reviewed by a panel of senior scientists from the Department of Medicine. Proposals will be judged on scientific-merit, rigor, and quality of project. Our intent is to complete reviews and start funding by July 1, 2023.
Additional details and application information can be found on the Mario Family Foundation Award webpage. For project-related questions, please contact Saini Pillai, MBA, Senior Program Coordinator, Chair’s Office.
2023 Loan Repayment Program to Promote Diversity and Inclusion in Medicine
The Duke Department of Medicine has announced the 2023 Loan Repayment Program to Promote Diversity and Inclusion in Medicine (LRPDIM). This award is part of a series of mentored career development opportunities offered by the Department of Medicine and is designed to fund members of groups underrepresented in medicine who, as a group, are disproportionately impacted by student loans. This financial burden impedes the retention, recruitment, and diversification of research faculty in our department.
We encourage investigators from diverse racial and ethnic backgrounds who are under-represented in Medicine to consider applying. The LRPDIM award repays up to $50,000, annually for up to two years, of a researcher’s qualified educational debt in return for a commitment to engage in research. Up to two applicants will be funded (July 1, 2023, through June 30, 2025). The award recipient must remain a full-time employee of the DOM to receive the full amount of the award. Award funds are not restricted and can be used at the awardee’s discretion. If the research commitment is not met, recipients must pay back the amount awarded.
The 2023 LRPDIM Award application deadline is May 12, 2023, at 5 p.m. Eligibility criteria, detailed information about the Award, and the application form are available on the DOM Loan Repayment Program to Promote Diversity and Inclusion website. For program-related questions, please contact Kimberly Dorman, Special Assistant to the Vice Chair for Faculty Development and Diversity in the Chair’s Office.
1st Open BAA for innovative high-impact research proposals
ARPA-H opened its first Agency-wide Open Broad Agency Announcement (Open BAA), seeking funding proposals for research aiming to improve health outcomes across patient populations, communities, diseases, and health conditions. The BAA calls for proposals to outline breakthrough research and technological advancements.
Proposals should investigate unconventional approaches, and challenge accepted assumptions to enable leaps forward in science, technology, systems, or related capabilities. ARPA-H also encourages concepts to advance the objectives of President Biden’s Cancer Moonshot, as well as more disease-agnostic approaches.
For questions, please contact baaquestions@arpa-h.gov.
Cardiac Safety Research Consortium Think Tank Meeting, June 7
The Cardiac Safety Research Consortium will hold a Think Tank meeting on June 7. The event, CSRC Think Tank: Update on Regulatory Status of Hypertension, Biomarkers and Arrhythmia Monitoring in Clinical Trials will be held at the FDA.
In Session 1, these leading industry professionals will speak on panels discussing:
- Regulations for ECG/QT
- The double-negative conundrum
- Alternative methods for assay sensitivity assessment in routine Phase 1 QT Studies
- Covid-19 and prolonged QT
In Session 2, we will discuss:
- Small increases in blood pressure and CV risk I
- Intermittent versus chronic use hypertension drugs
In Session 3, the meeting faculty will dive into:
- Biomarkers
In Session 4, the panelists will discuss hot topics in the field such as:
- Biologics/cardiomyopathy and vaccine development
- MACE
- Gene therapies
- Wearables
The event will include professionals from FDA Regulatory, Cardiac Safety Consultants, Ltd., Eli Lilly, Richmond Pharmacology, University of Connecticut, Stanford University, University of Pennsylvania, Cleveland Clinic, Clario, Mass General, DSI, Penn Medicine, and UCSF.
There is a registration fee for attendance, for academics it is $275. Registration and more information is available here: https://cardiac-safety.org/
The meeting will be held in person; a recording of the meeting and slide presentations will become available a month after the event occurs.
Have news to share?
If you have news to share with the Pulse readership, please contact Tracey Koepke, director of communications for Duke Heart at tracey.koepke@duke.edu. We would love to hear about your latest accomplishments, professional news, cool happenings, and any events or opportunities that may be of interest to our Duke Heart family. Please call with any questions: 919-681-2868. Feedback on Pulse is welcome and encouraged. Submissions by Noon, Wednesdays, to be considered for weekend inclusion.
Duke Heart in the News:
April 6 — Joseph Lerman
Diagnostic and Interventional Cardiology
https://duke.is/p9x5k
April 9 — Neha Pagidipati
Health Digest
Weight Loss Can Be Heart Healthy Even If Some Pounds Return
https://duke.is/4qnme
April 10 — Allison Dimsdale
Healthleaders
The Exec: Advanced practice providers key to managing physician shortages
https://duke.is/zj7qq
April 10 — Michael Pencina
The Evolving Enterprise
Coalition for Health AI unveils Blueprint for Trustworthy AI in healthcare
https://duke.is/msrhm
April 11 — Duke University (Geoff Ginsburg)
NC Health News
https://duke.is/rrxxm
April 11 — Pamela Douglas
NIH News
https://duke.is/vnmfa
April 13 — Thomas D’Amico
Triangle Business Journal
2023 Health Care Leadership Awards: Dr. Thomas D’Amico – Duke Thoracic Surgery
https://duke.box.com/s/xfjh6pqxr21w1y6to2b5vnhhtagnpx3t
(link is to a PDF)
April 13 — David H. Noyd (adjunct pediatrics)
Healio/Cardiology
CV risk factor disparities in childhood cancer survivors similar to general population
https://duke.is/jtn4u
April 13 — Christopher Granger
Medpage Today
Standard-Dose DOAC Better for Kidney-Impaired Patients
https://duke.is/yuhvj
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