Celebrating the Efforts of Clinical Researchers
Clinical Trials Day is celebrated May 20 to recognize the efforts of clinical research professionals around the globe. It is a great opportunity to acknowledge how the research we do every day throughout our clinics helps to advance medicine and improve the health of our patients and communities.
To celebrate Clinical Trials Day, we ask just a few of our principal investigators (PIs) to tell us about research currently in progress.
REVAMP (REmodeling the Left Ventricle with Atrial Modulated Pacing)
PI:Ilknur Can, MD
Objective:Â The primary objective of this study is to assess the feasibility of using elevated night pacing as a therapy for heart failure with preserved ejection fraction.
What activities are taking place in clinic that support the study?
Patients are identified in the Clinics and Surgery Center by the Investigators and colleagues who are seeing these patients at routine clinic appointments, scheduled pacemaker checks and scheduled echocardiograms.
How will the study improve patient care in the future?
It is projected that an estimated 8.5 million people in the United States will have heart failure (HF) by 2030, and approximately 50% of these HF patients will have a preserved ejection fraction (HFpEF). In contrast to HF with reduced EF (HFrEF), no effective drug or device therapies have been identified that improve the prognosis of the disease. The hypothesis that raising heart rates can promote a beneficial left ventricle (LV) dilation, which will reduce chamber stiffness and improve diastolic filling in HFpEF patients that have thickened ventricular walls and normal to small LV volumes.
What are you most excited about regarding this study?
This is a feasibility study and could possibly improve quality of life and change the way we treat this large patient population.
Use of Thirty Minute Office Blood Pressure Monitoring to Improve Blood Pressure Measurement in a Family Medicine ClinicÂ
PI: Ann Philbrick, PharmD, FCCP, BCPS, BCACP
Description:Â Thirty Minute Office Blood Pressure Monitoring (OBP-30) entails placing an ambulatory blood pressure monitor on a patient and leaving them undisturbed for 30 minutes while blood pressure readings are obtained every five minutes. It results in seven readings, of which the last five are averaged for a final reading. This final reading is considered the patient's "true" blood pressure, and is usually lower than the initial clinic reading.
Objectives: To determine whether OBP-30 significantly impacts clinical care in a family medicine clinic by quantifying difference between supine office blood pressure (SOBP) and OBP-30 and assessing clinical decision impact of results.
What activities are taking place in clinic that support the study?
Patients with diabetes and or cardiovascular disease and uncontrolled hypertension are currently being recruited in the Bethesda Family Medicine Clinic; plans are to begin enrolling patients as recommended by their physician soon.Â
How will the study improve patient care in the future?
The study will help provide a more accurate picture of a patient's blood pressure, and the care team will be able to tell who really needs treatment intensification and who tends to have a higher blood pressure when they first arrive.Â
What are you most excited about regarding this study?Â
The potential for this process to become the standard of care for all patients with elevated blood pressure when they arrive in clinic. Taking blood pressures over 30 minutes would not be feasible in a busy clinic, but taking three to four serial blood pressures over 5-10 minutes could be enough to see a substantial drop in blood pressure.Â
Development of new closed loop devices for deep brain stimulation for treating mental health illnessesÂ
PI: Alik Widge, MD, PhD
Objectives: (1) test a new kind of brain stimulation for severe obsessive-compulsive disorder (OCD) and (2) to understand how stimulation changes the brain networks that cause OCD.
Description: We are stimulating multiple brain sites at once to disrupt those brain networks, and using new technology from Medtronic to directly measure the effect of stimulation on the brain's electrical activity.
What activities are taking place in clinic that support the study?
The Psychiatry Clinic now offers consultation for any psychiatrist or psychologist in the general Minnesota community who has a patient with difficult-to-treat OCD. We will review their patient's chart and perform a thorough evaluation, then offer recommendations for further treatments. These may include medications, behavior therapy, a type of non-invasive brain stimulation called TMS, or brain surgery such as this clinical trial.Â
How will the study improve patient care in the future?
The study will improve patient care in a few ways. First, patients who participate in the study will hopefully get symptom relief that they have been unable to get through any other treatment. Second, the brain recordings will help us understand a critical network, called the cortico-striatal loops that are important to illnesses beyond OCD. This same brain network is involved in addiction, depression, and maybe also PTSD, and our findings could lead to new treatments for those disorders too. Third and finally, the study has allowed us to open that consultation clinic, which is letting us improve the psychiatric care even of patients who are not in the study.
What are you most excited about regarding this study?Â
This might be the first opportunity in the world for a team to directly observe the brain basis of a mental illness and then try to change it. We have a real difficulty in psychiatry with treatments that work at a population level, but not for everyone. Doing this work brings us closer to precision medicine that will let us tailor our treatment to help every patient.
ASPREE XT or ASPirin in Reducing Events in the Elderly, eXTension
PI:Kevin A. Peterson, MD, MPH
Objectives: We are looking at the long-term effects of aspirin in cancer, cognitive decline and other diseases associated with aging. It’s an excellent opportunity to understand factors that affect the quality of life.
Description: This is an observational follow up of the ASPREE Study. The ASPREE clinical trial looked at the role of low dose aspirin in preventing cancer, cardiovascular disease and cognitive and physical decline in people over the age of 70. The ASPREE Study results were published in three articles of the New England Journal of Medicine and have been presented at conferences worldwide. ASPREE XT is funded by the National Institute of Aging and the National Cancer Institute. The study is being done in 33 sites in the U.S. and many more in Australia.
What activities are taking place in clinic that support the study?
ASPREE XT patients come to the Phalen Village Family Medicine Clinic once a year for a visit that includes a variety of memory tests, some physical tests such as hand strength and gait speed and a review of their current health status. Many of the participants have already been volunteering for this study for nine years. Patients are no longer randomly assigned to either aspirin or placebo but their aspirin use is reported. Some of the participants have provided DNA samples that will be used to look for genetic links with certain cancers.
How will the study improve patient care in the future?
The results are helping inform the people who develop guidelines for aspirin use in the elderly. The study is exploring which medicines and lifestyles can promote a long and healthy life. Â Â
What are you most excited about regarding this study?
Seeing the participants and talking to them on the phone is one of the greatest joys in healthcare. Our patients range in age from 75 to 97 years old. Over time, we have come to know each other well.
Ultrasound treatment of rheumatoid arthritis
PI:Erik Peterson, MD
Objectives: Determine if ultrasound stimulation of the spleen is an effective treatment for rheumatoid arthritis.
Description: Investigating the feasibility of treating rheumatoid arthritis with targeted ultrasound treatment of the spleen. Qualifying study participants are sent home with a portable ultrasound machine and are instructed on how to perform daily 30 minute treatment sessions in their home. Participants also attend six study visits over the three week study period in which clinical examination, ultrasound imaging of the joints, and blood inflammation markers are assessed. This study is taking place in the Clinics and Surgery Center.
What activities are taking place in clinic that support the study?
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Participants have blood drawn in the clinic at all 6 visits, with some markers analyzed in house and other blood taken to our laboratory for further analysis.
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On visit one, the radiology department identifies, measures, and marks the location of the spleen on the participant's abdomen. This is used as the target mark for ultrasound stimulation for the remainder of the study.
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On all six visits in the clinic, Dr. Peterson and other study personnel perform clinical examinations, ultrasound imaging of the joints and assess other biomarkers and signs of disease.
How will the study improve patient care in the future?
If proven safe and effective, ultrasound stimulation of the spleen has the potential to provide supplemental or alternative treatment of rheumatoid arthritis or other inflammatory diseases.Â
What are you most excited about regarding this study?Â
We have the opportunity for the University's biomedical research teams to collaborate with physicians in the clinic. This partnership provides seamless access to interested study participants and enables investigation of novel therapies and treatment approaches.
CLEANUP-IPF
PI:Hyun Kim, MD
Objectives: To determine if an antibiotic will help lung function in patients with idiopathic pulmonary fibrosis (IPF).
Description: This is a multicenter, randomized study sponsored by the NIH. The hypothesis is that treating bacteria in the lungs of patients with idiopathic pulmonary fibrosis will help lung function. We are doing the study in the Interstitial Lung Disease Clinic in the CSC in conjunction with the patients' regular clinic visits.
What activities are taking place in clinic that support the study?
Study visits occur concurrently with the patients' regular clinic visits at the Clinics and Surgery Center. The study collects test results that are performed for routine clinical care.
How will the study improve patient care in the future?
If the study is positive, then a simple and inexpensive intervention (a daily antibiotic) will help lung function.
What are you most excited about regarding this study?Â
This is a pragmatic clinical trial, meaning that real world patients are eligible for the study instead of the usual strict inclusion and exclusion criteria that exclude the majority of people who are interested in participating in a clinical trial.Â
NIHÂ study looking at the impact of recurrent hypoglycemia on brain glucose transport in type 1 diabetes
PI: Betsy Seaquist, MD
Objectives: Examine the impact of administering narcan during exercise on day one on the preservation of the response to hypoglycemia on day two in patients with type 1 diabetes.Â
What activities are taking place in clinic that support the study?
To do the study each subject is asked to do two 90 minute periods of exercise on a bike in the Univeristy of Minnesota Health Clinical Research Unit (CRU) on day one, and then undergo a period of hypoglycemia the next day. They do this on two occasions, once when they are given intranasal narcan and another when they are given intranasal saline.
How will the study improve patient care in the future?
If successful this study will suggest that intranasal narcan could be used during exercise to make sure the response to hypoglycemia is not reduced as it usually is.
A Phase II Study of Pembrolizumab in Combination with Carboplatin & Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma. Â BIG10 Cancer Research Consortium.
PI:Deanna Teoh, MD, Co-PI at Maple Grove Clinics, Colleen Rivard, MD
Objectives: Evaluate the effectiveness of standard of care chemotherapy given with a new immunotherapy when treating women who have endometrial cancer.
What activities are taking place in clinic that support the study?
Patients receive usual care from the clinic staff and one additional medication is included in the infusion they receive every three weeks. The effectiveness of the treatment is assessed with periodic CT scans.
How will the study improve patient care in the future?
If the study demonstrates an improvement in the treatment of endometrial cancer, it could change the therapy women receive in the future.
What are you most excited about regarding this study?
A patient who enrolled in this CTO study is receiving her care at the University of Minnesota Health Maple Grove Cancer Care Clinic. To date, there has been a significant reduction in the size of her tumor. It’s exciting that clinical trials can be offered in the community, with patients receiving the same level of care and they can continue to see their community oncologist.  Also, many patients and their families prefer the community location because it is closer to home, and they are reluctant to drive to University of Minnesota to receive care. The traffic and road closures are intimidating.  In the past, these factors have been a barrier to participation in a clinical trial.  We do collaborate with University of Minnesota staff, and patients will go there for any care that can’t be provided at our community clinic.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Severe or Very Severe Alopecia Areata
PI: Maria Hordinsky, MD
Objectives: 1) To compare the efficacy of baricitinib a janus kinase (JAK) 1, JAK2 inhibitor,  high dose or low dosage to placebo in Alopecia Areata, an autoimmune disease with  no FDA approved treatment. Both children and adults  with this disease experience patchy or total body hair loss that is episodic.  2) To compare the maintenance of efficacy for patients randomized to remain on baricitinib, compared with patients randomized to placebo.
What activities are taking place in clinic that support the study?
During regularly scheduled clinic visits, Alopecia areata patients are presented with the opportunity to participate in clinical trials including this one.
How will the study improve patient care in the future?
Currently there is no FDA approved treatment for alopecia areata. This is one of many studies currently investigating both topical and systemic janus kinase inhibitors to treat alopecia areata.
What are you most excited about regarding this study?Â
With the multiple ongoing JAK inhibitor studies, we anticipate one if not more will result in a future viable and safe treatment to offer Alopecia Areata patients.