Clinical Studies & Trials

Resuscitation science is a developing sub-specialty of Interventional Cardiology under the leadership of Demetri Yannopoulos, MD. The focus of this center is to conduct research that focuses on all aspects of resuscitation from sudden cardiac arrest. This center will conduct research to answer critical questions about new treatments, innovative medical devices, and strategies for patient management that spans from bystander response, pre-hospital providers, and in-hospital care. The clinical research team includes partnerships with the Lillihei Clinical Research Unit, and the Center for Biometric Research supported by National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114.

Basic Science Laboratory

The laboratory focuses on understanding the mechanisms of cell death that occur during cardiac arrest while also testing various treatment strategies to prevent damage and increase the likelihood of functional recovery. The lab, at the University of Minnesota, is one of the most advanced models to study sudden cardiac death in the nation. Our studies span the fields of biochemistry, molecular biology, cell biology, biomedical engineering, physiology, and medicine. The assembled team is an interdisciplinary group of investigators that are focused on the development of studies that ensure results that can be translated in to patient care models. The expansion of knowledge acquisition will continue to rise from the studies conducted, as a wide spectrum of expertise and capital investment is in place. The team looks forward to continued discoveries and innovative solutions to the problem of sudden cardiac death.

Center for Resuscitation Medicine

The University of Minnesota and Center for Resuscitation Medicine have led several important research initiatives that are dedicated to the development, evaluation, and advancement of novel, lifesaving protocols and technologies. One of the results of this work is that the Twin Cities became the first large metropolitan area with a unified cardiac catheterization laboratory access protocol for patients who experience out-of-hospital cardiac arrest. Partners are also working to develop effective therapies for sudden cardiac arrest. They are testing promising new medications that could protect the heart and brain from cardiac arrest and resuscitation-related injuries. The future holds the potential for a clinical study on a life support therapy that could improve cardio-cerebral outcomes in patients who do not receive bystander CPR and experience prolonged untreated cardiac arrest.

“A strategic approach to implementation of resuscitation science discoveries and new therapies is required to foster evidence adoption, use, and sustainability. Once a new treatment has demonstrated benefit in controlled clinical trials, it must be tested in increasingly realistic settings to confirm effectiveness and to identify the optimal clinical practice protocols. Translational research focuses on the translation of new findings in basic science into new treatments and the adoption of those treatments in practice (Rubio et al., 2010). In the resuscitation field, guidelines are a predominant mechanism for translating research into practice. The rapid translation of basic research findings into new treatments and the adoption of new treatments into practice is more likely if clinical trials and related studies are designed to produce results that can facilitate evidence-based practice.” 

ACCESS TRIAL            ARREST TRIAL

The Lillehei Clinical Research Unit (LCRU) supports the research activities for the Cardiovascular Division clinical faculty at the University of Minnesota. The LCRU is currently conducting approximately 60 clinical trials in various phases of enrollment and follow-up with a mix of investigator initiated, industry sponsored and government sponsored trails.

Active areas of study include: Stem Cell Therapy, Interventional Cardiology, Electrophysiology, Congestive Heart Failure, Heart Transplant, Ventricle Assist Devices, Cardiac Imaging, Pulmonary Hypertension, Primary and Secondary Prevention and Vascular Disease.

CLINICAL TRIALS

The EDIC study is a multicenter, observational study designed to follow the type 1 diabetic volunteers who participated in the Diabetes Control and Complications Trial (DCCT). EDIC is now in its 23rd year of follow-up.

This study is currently following participants.

CLINICAL TRIALS

What is the Study about?

The purpose of this study is to evaluate whether finerenone is effective and safe in treating patients with type 2 diabetes and Diabetic Kidney Disease in addition to regular therapy. Type 2 diabetes is a chronic disease in which the body is unable to properly use insulin, a hormone that regulates blood sugar levels, or does not produce enough insulin, typically leading to increased blood sugar levels and other complications. Diabetic kidney disease is a complication affecting the kidneys of patients with diabetes. More commonly, it develops in people who have had diabetes for at least 10 years. This study will look at the progression of kidney disease in participants with type 2 diabetes and diabetic kidney disease.

Eligibility to participate

• Are between the age of 18 – 70 years
• Have type 2 diabetes
• Have diabetic kidney disease

What is involved in the Study?

Participants will be randomly assigned (like the flip of a coin) to receive either finerenone or a placebo and come to the University of Minnesota for 12 visits over 3 years. At these visits medical history will be reviewed, an electrocardiogram (ECG) taken, and blood and urine collected for laboratory testing. Compensation is available.

Principal Investigator
Luiza Caramori, MD, PhD, MSc

More Information
Birgit Fink
finkx120@umn.edu
(612) 301-2103

What is the Study about?

The purpose of this study is to evaluate whether finerenone is effective and safe in reducing the incidence of cardiovascular events in patients with type 2 diabetes and diabetic kidney disease. Type 2 diabetes is a chronic disease in which the body is unable to properly use insulin, a hormone that regulates blood sugar levels, or does not produce enough insulin, typically leading to increased blood sugar levels and other complications. Along with diabetic kidney disease, cardiovascular disease is a common and major complication affecting patients with type 2 diabetes. This study will look at the number of cardiovascular events in participants with type 2 diabetes and diabetic kidney disease and compare these rates among patients receiving finerenone or placebo.

Eligibility to participate

• Are between the age of 18 – 70 years
• Have type 2 diabetes
• Have diabetic kidney disease

What is involved in the Study?

Participants will be randomly assigned (like the flip of a coin) to receive either finerenone or a placebo and come to the University of Minnesota for 12 visits over 3 years. At these visits medical history will be reviewed, an electrocardiogram (ECG) taken, and blood and urine collected for laboratory testing. Compensation is available.

Principal Investigator
Luiza Caramori, MD, PhD, MSc

A Comparative Effectiveness Study (GRADE)

What is GRADE?
GRADE is a long-term study of different treatments for type 2 diabetes funded by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH). Type 2 diabetes is an epidemic that threatens to become the century's major public health problem and poses enormous human and economic challenges worldwide. Most people with diabetes eventually need 2 medications to control blood glucose levels. A major challenge is to determine which of the many possible drugs is the best choice among people already treated with metformin, the most commonly used diabetes drug. GRADE will determine which combination of two medications is best for glycemic control, has the fewest side effects, and is the most beneficial for overall health.

What is involved in the Study?

• 2 medications taken daily – metformin and a randomly selected second medication at no charge to participant
• Blood sugar tested up to 2 times daily at home
• After an initial period, visits to the University of Minnesota every 3 months until the projected end of the study in 2021.
• Optional participation in 3 related sub-studies

Principal Investigator
Elizabeth Seaquist, MD

Grade Team
grade@umn.edu
(612) 626-0143

GRADE WEBSITE   CLINICAL TRIAL

Naloxone, Hypoglycemia & Exercise

Preventing hypoglycemia after exercise can be difficult. The purpose of this study is to learn if naloxone can be used to treat exercise-related hypoglycemia symptoms. Naloxone is currently used as a substance abuse treatment medication but research studies have shown it to possibly be effective in preventing next-day hypoglycemia.

This study is looking for people who:

• Are between the age of 18 – 65
• Have type 1 diabetes for 2 - 30 years
• Are willing to avoid exercise for the week before the study

This study involves one (1) screening visit where you will ride an exercise bike to determine your V02 max and wear a continuous glucose sensor (CGM). About 1 week later, you will return to the University of Minnesota for one (1) full day and one half (1/2) day visit. At the full day visit, you will ride an exercise bike and be given either naloxone or a placebo. The following day, we will lower your blood sugar to make you hypoglycemic and ask you about your symptoms. You will return about 8 weeks later to repeat the full day and half day parts of the study. If all parts of the study are completed, compensation is up to $675.

Cerebral Responses to Insulin-Induced Hypoglycemia

The purpose of this study is to determine what happens in different parts of the brain in response to hypoglycemia (low blood sugar). Hypoglycemia is a serious complication of diabetes treatments and having a greater understanding of how the brain adapts to low blood sugar may help us develop better and safer ways to treat diabetes.

This study is looking for people who:

• Are between the age of 18 – 65
• Have type 1 diabetes
• Can undergo MRI scanning

This study involves one (1) half day visit (about 5 hours) to the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. While in a magnetic resonance scanner (MRI), we will make you hypoglycemic. Images of the brain will be taken with the MRI and blood will be collected for additional tests. Compensation for this study is $150.

Recurrent Hypoglycemia in Type 1 Diabetes

Individuals with type 1 diabetes often develop an impaired awareness of hypoglycemia (IAH), meaning they are not fully aware of having low blood glucose levels. This research study is looking to determine what happens in the brain after repeat episodes of hypoglycemia. Having a greater understanding of how the brain adapts to low blood sugar may help us develop better and safer ways to treat diabetes.

This study is looking for people who:

• Are between the age of 18 – 65
• Have type 1 diabetes for 2 - 25 years
• Can undergo MRI scanning

This study involves one (1) screening visit, wearing a continuous glucose sensor (CGM) and an activity/sleep tracker, and two (2) full day visits to the University of Minnesota Center for Magnetic Resonance Research (CMRR). On each of the full day visits, you will have your blood sugar lowered 2 times and we will take 1 MRI scan of your brain. If all parts of the study are completed, compensation is up to $1,025.

Principal Investigator
Elizabeth Seaquist, MD

For More Information
studydiabetes@umn.edu
(612) 301-7040

PERL stands for Preventing Early Renal Function Loss in Diabetes. The PERL study is a three-year multi-center study aiming to determine whether allopurinol can reduce loss of renal function in people with type 1 diabetes. Patients with type 1 diabetes remain at risk for end-stage renal disease despite improvements in blood pressure and blood glucose control. Allopurinol is a medication that has been on the market for almost 50 years, has an excellent safety profile, and is used to prevent gout in patients with elevated uric acid levels. There is evidence suggesting that allopurinol might also be useful in people with diabetes who have normal or moderately impaired kidney function to decrease the risk of developing advanced kidney disease in the future.

Eligibility to participate

You may be eligible to participate in the PERL study if you:

• Are between the ages of 18 – 70 years
• Have type 1 diabetes for at least 8 years
• Are concerned you may have or may develop kidney problems related to diabetes

This study does not accept healthy participants. This study is currently following participants.

What is involved in the Study?

• Participants will be randomly selected to take allopurinol or a placebo (inactive pill) for three years.
• During this time, participants will periodically have follow up visits at the University of Minnesota.
• Kidney function will be measured at the beginning and at the end of the treatment period

Ancillary Studies

Continuous Glucose Monitoring (CGM)
The purpose of this study is to assess the role of glycemic variability (daily changes in the level of blood glucose) in the progression of kidney disease caused by diabetes in individuals who have mild to moderate kidney disease.

Kidney Biopsy
The purpose of this study is to obtain kidney tissue which, in combination with the data obtained in the main PERL study, will be studied to identify new ways to predict who will develop more serious diabetic kidney disease and identify potential targets for new therapies.

Measuring GFR using Filter Paper
The purpose of this study is to learn more about measuring kidney function with iohexol clearance using a drop of blood from the finger (a finger stick). This less burdensome method to reliably measure iohexol clearance has the potential to significantly enhance how research in diabetic kidney disease, other forms of kidney disease, and eventually clinical care is provided. 

Principal Investigator
Luiza Caramori, MD, PhD, MSc

More Information
Birgit Fink
finkx120@umn.edu
(612) 301-2103

STUDY WEBSITE    CLINICALTRIALS

What is REWIND?

The Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) study aims to see whether the investigational drug, dulaglutide, can safely reduce the development of serious heart disease or stroke in people with type 2 diabetes who are at high risk for these conditions.

This study is currently following participants. 

Principal Investigator
Elizabeth Seaquist, MD

For More Information
Mike Mech, RN
mechx003@umn.edu
(612) 624-6697

Acute Effects of Exercise on Muscle Metabolism

University of Minnesota study is looking for healthy participants to see how acute exercise may alter muscle metabolism. We are looking for healthy people (Age 18-45) who are otherwise in good health. The study will involve 2 outpatient visits (one visit is 2 hours, one visit is 5 hours) at the University of Minnesota.

The first visit will involve measuring your fitness by having you exercise on a treadmill. At the second visit, we will measure your leg muscle metabolism by sampling your muscle using a small needle in an outpatient procedure with local anesthesia before, immediately after, and 2 hours after acute exercise. (3 biopsies total). The exercise will be supervised walking/jogging on a treadmill for about 40 minutes ( 2 sessions of 20 minutes, separated by 5 minutes). Each muscle sample will be roughly the size of 2 pencil erasers. This is a well-established technique which has been performed on high-level athletes for muscle evaluation and has been performed previously in studies looking at acute exercise. The purpose of this study is to see how acute exercise affects muscle fat turnover.

Study Requirements

• Asked to visit the University of Minnesota 2 times, to include
• 1 screening visit
• 1 visit to assess metabolism
• Running capacity and muscle fat content (by needle sampling of the muscle) will be assessed
• Expected participation is approximately 2 weeks

Principal Investigator
Lisa Chow, MD

For More Information
endores@umn.edu
(612) 624-1469

Improve your fitness by participating in the University of Minnesota/National Institute of Health TrainMeUp MN study! 

The study investigates how exercise might alter fitness and improve metabolism before and after a running or yoga routine. The investigators are interested in how skeletal muscle processes fat and how this may affect insulin resistance. This is an important question since insulin resistance predates and predicts type 2 diabetes. The investigators are especially interested in learning about the effects of weight and training on insulin resistance.

Eligibility to participate

You may be eligible to participate in the TrainMeUp MN Study if you are:

• Between the ages of 18–40
• Generally healthy
• Overweight (BMI>25) and have no active exercise program (less than 30 min/week)
• Lean (BMI <25) and an active runner (45 min/day, 5 days per week)

What is involved in the Study?

Overweight participants will be: 

• Randomly selected to enter into either a treadmill training program or yoga program for 16 weeks at a local fitness center close to you.
• Asked to visit the University of Minnesota 8 times, to include
• 1 screening visit
• 3 pre-training visits
• 1 mid-training visit
• 3 post-training visits
• Pre- and post-training visits will measure fitness, body composition, muscle fat content (by needle sampling of the muscle) and the body’s use of sugar and fat
• Expected participation is approximately 6 months

Lean participants will be:

• Asked to visit the University of Minnesota 4 times, to include
• 1 screening visit
• 3 visits to assess metabolism
• Running capacity, body composition, muscle fat content (by needle sampling of the muscle) and the body’s use of sugar and fat will be assessed
• Expected participation is approximately 3 months

Principal Investigator
Lisa Chow, MD

For More Information
endores@umn.edu
(612) 624-1469

This Study aims to investigate the effects of diabetes and its treatments on brain metabolism and function. Diabetes mellitus is a complex disease that affects many, if not all, of the organs in the body. The leading cause of end stage kidney disease in the United States, diabetes is also a common cause of vision loss, nerve problems, and heart disease. Whether diabetes has an effect on the central nervous system was uncertain for many years, but as patients with diabetes live longer and better with the disease, the consequences of diabetes on the brain are now becoming apparent. Both the high blood sugar and the low blood sugar associated with diabetes treatment have been thought to alter the structure and function of the brain. It is the goal of this project to determine the effects of diabetes on the brain.

Are you eligible to participate?

You may be eligible to participate in this Study if you:

• Are over the age of 18
• Have Type 1 diabetes for more than 25 years

This study is also accepting healthy participants.

What is involved in the Study?

Participants with diabetes and healthy participants will be asked to visit the University of Minnesota twice (2) for approximately 2 ½ hours each time.

• 1st visit – Blood sugar will be measured and a blood sample taken. A series of mental test designed to measure memory and the ability to process information will be given.
• 2nd visit – Blood sugar will be measured and a blood sample taken. A brain scan in an MRI machine will be preformed.

Principal Investigator
Elizabeth Seaquist, MD

More Information
Anjali Kumar, PA- C
kumar045@umn.edu
(612) 624-0470

An open label, Phase II study evaluating the safety and efficacy of INCB050465 in the treatment of participants with AIHA (autoimmune hemolytic anemia).

Principal Investigator
Greg Vercellotti, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

A Phase II, randomized, dose-blind study evaluating the safety, tolerability, and efficacy of KZR-616 in the treatment of participants with AIHA (autoimmune hemolytic anemia) or Immune Thrombocytopenia (ITP).

Principal Investigator
Greg Vercellotti, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

GeneR8-1
A Phase III open-label, single-arm study to evaluate the efficacy and safety of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene transfer of Human Factor VIII in Hemophilia A patients with residual FVIII levels ≤ 1 IU/dL receiving prophylactic FVIII infusions (BMN 270-301).

Principal Investigator
Mark Reding, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

HEM-POWR
An observational study evaluating effectiveness and safety of real-world treatment with Damoctocog alfa pegol in previously treated patients with Hemophilia A.

Principal Investigator
Joan Beckman, MD, PhD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

HITOVA
An open-label, randomized, active controlled, multi-center Phase III study to evaluate the safety and efficacy of Danaparoid vs Argatroban in treatment of subjects with acute HIT. This is a hospital-based study with follow-up.

Principal Investigator
Surbhi Shah, MBBS

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

A Phase II, randomized, dose-blind study evaluating the safety, tolerability, and efficacy of KZR-616 in the treatment of participants with AIHA (autoimmune hemolytic anemia) or Immune Thrombocytopenia (ITP).

Principal Investigator
Greg Vercellotti, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

Role of endothelial cells in MPN in bleeding and clotting. Non-interventional, observation study to investigate mechanisms of bleeding and clotting in MPN patients. The study collects blood at routine visits. 

Princiapl Invesigator
Joan Beckman, MD, PhD

More Information
Musa Jama
jamax165@umn.edu
(612) 624-5773

7201:Longitudinal Study of the Porphyrias
The objective of this study is to conduct a longitudinal investigation of the natural history, complications and therapeutic outcomes in people with acute and cutaneous porphyria.

Principal Investigator
Marshall Mazepa, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

Sickle Cell and the Endothelium. Non-interventional, observation study to investigate endothelial biomarkers in individuals with Sickle Cell and Sickle Cell trait. The study collects blood at routine visits.

Principal Investigator
Greg Vercellotti, MD

More Information
Muse Jama
jamax165@umn.edu
(612) 624-5773

USTMA P201
A Pilot Study of Acquired Thrombocytopenic Purpura and Neuropsychologic Complications: A multi-center, prospective, and longitudinal study of neuropsychological complications in patients with acquired TTP in remission.

Principal Investigator
Marshall Mazepa, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

USTMA P200
United States Thrombotic Microangiopathy (USTMA) Thrombotic Thrombocytopenic Purpura (TTP) Clinical Data and Biologic Sample Repository.  The primary objective of this study is to establish a tissue and clinical data repository of patients diagnosed with thrombotic thrombocytopenic purpura (TTP) for patients that are treated at member institutions of the United States Thrombotic Microangiopathy (USTMA) consortium.

Principal Investigator
Marshall Mazepa, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

A Phase II, multi-center, randomized, placebo-controlled, double blind study in patients with acquired thrombotic thrombocytopenia purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment.

Principal Investigator
Yvonne Datta, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

Phase 2 Trial
Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

Principal Investigator
Patrick H. Nachman

Study Coordinators
Charlotte Quinton, RN, BSN
quint003@umn.edu

Elizabeth Miller, RN, BAN, PHN, CCRC
mill7440@umn.edu

CLINICAL TRIAL

Phase 3 Trial
A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

Principal Investigator
Michelle Rheault, MD

CLINICAL TRIAL

Study Coordinators
Elizabeth Miller, RN, BAN, PHN, CCRC
mill7440@umn.edu

Mary McDonald, RN, CCRP
mcdo0664@umn.edu

CLINICAL TRIAL

Phase 2 Trial

An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome

Principal Investigator
Patrick H. Nachman, MD

Study Coordinators
Elizabeth Miller, RN, BAN, PHN, CCRC
mill7440@umn.edu

Mary McDonald, RN, CCRP
mcdo0664@umn.edu

CLINICAL TRIAL

Phase 2 Trial
An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis

Principal Investigator
Patrick H. Nachman, MD

Study Coordinators
Elizabeth Miller, RN, BAN, PHN, CCRC
mill7440@umn.edu

Mary McDonald, RN, CCRP
mcdo0664@umn.edu

CLINICAL TRIAL

Phase 3 Trial

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)

Principal Investigator
Surabhi Thakar, MD

Study Coordinators
Elizabeth Miller, RN, BAN, PHN, CCRC
mill7440@umn.edu

Mary McDonald, RN, CCRP
mcdo0664@umn.edu

CLINICAL TRIAL

Phase 3 Trial

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)

Principal Investigator
Patrick H. Nachman, MD

Study Coordinators
Elizabeth Miller, RN, BAN, PHN, CCRC
mill7440@umn.edu

Mary McDonald, RN, CCRP
mcdo0664@umn.edu

CLINICAL TRIAL

Phase 2 Trial

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus 

Principal Investigator
Dr. Parastoo Fazeli

Study Coordinator
Julie Scherber
sche0245@umn.edu

CLINICAL TRIAL