Clinical Research Trials

At Bryan Heart, our reputation in heart care gives you access to national research trials

Bryan Heart is a well-known and respected partner in national clinical trials. This reputation benefits you by providing access to additional treatment options not otherwise available in our region.

Your treatment team will share information with you if clinical trial participation is an appropriate option to consider for your treatment.

What is a Clinical Research Study?

A clinical research study, also called a clinical trial, is a carefully designed and closely regulated study of the safety and effectiveness of new, innovative procedures, medications or devices. The purpose of any study is to determine if a new therapy will be effective and safe in preventing, diagnosing or treating people with specific diseases or conditions.

How is Clinical Research Conducted?

Clinical research can be a long and detailed process, beginning in the laboratory where proven theories are tested. If successful, the next step is the preclinical phase.

Preclinical Research

This is done before clinical trials (testing in humans) can begin. The main goal of preclinical research is to determine if a product is safe. This applies to drugs, devices and gene therapy. Each type of product may undergo different types of testing. The information collected from these studies is vital so that safe human testing can begin. Drug testing may involve animal testing in two species.

Clinical Research Phases

Clinical research is made up of four phases:

  • Phase I research studies are the first step in testing any new treatment in humans. These studies usually have 20 participants or less and are designed to show whether a treatment is safe in humans. Often this includes healthy volunteers, and in drug studies can include increases in dose to evaluate the best dose.
  • Phase II trials are further tests of safety in a larger number of people, usually 50-200. In addition to safety, effectiveness is beginning to be evaluated, and in drug trials, final dosing regimens are often determined at this phase.
  • Phase III trials are done to prove the effectiveness of the new treatment. Most of these studies compare the new treatment to current standard therapy. In drug studies, this is done by comparing the new study drug to a placebo. A placebo is a harmless, inactive substance. One group of patients will receive the active study drug and one group will receive placebo, so that it can be determined whether the study drug is worse, equal or better than current standard therapy. To prevent any bias on the part of the patient or researchers, the study is ‘blinded’. This means that the patient, the research staff and the doctor do not know which group a patient is in. When the study is complete, data is analyzed and submitted to the FDA for approval of the new treatment.
  • Phase IV trials are done to determine whether a drug already approved by the FDA could be used for new treatments. For example, a drug that was was approved for prevention of clots in orthopedic patients, then being studied in patients with heart disease who need clot prevention.

Learn More About Clinical Research Trials at Bryan Heart

For information on current clinical trials available at Bryan Heart, please call 402-483-3333.

Available Clinical Trials

AIM HIGHer

  • Study Name: Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction
  • Study Sponsor: Impulse Dynamics, Inc.
  • Principal Investigator: Grant Wallace, MD
  • Category: Heart Failure
  • Description: Evaluate the efficacy and safety of cardiac contractility modulation (CCM®) therapy, utilizing the OPTIMIZER® Smart Mini System in patients with symptomatic heart failure with preserved ejection fractions (HF with EF 40-70%). This system is indicated for the improvement of health status, functional capacity, heart failure related adverse events, and cardiovascular mortality.
  • Status: Currently enrolling

Learn More About AIM HIGHer

BalanceD-HF

  • Study Name: A study to evaluate the effect of Balcinrenone/dapagliflozin, compared with Dapagliflozin, on risk of Heart Failure events and Cardiovascular Death in patients with Heart Failure and Impaired Kidney Function
  • Study Sponsor: AstraZeneca
  • Principal Investigator: Mathue Baker, MD
  • Category: Heart Failure and Impaired Kidney Function
  • Description: The purpose of the study is to evaluate the safety of balcinrenone in combination with dapagliflozin compared with dapagliflozin in patients with chronic HF, across all ranges of ejection fractions, and impaired kidney function.
  • Status: Currently enrolling

Learn More About BalanceD-HF

LAC-HF

  • Study Name: Continuous Lactate Monitoring in Ambulatory Chronic Heart Failure Patients (LAC-HF)
  • Study Sponsor: Abbott Diabetes Care
  • Principal Investigator: Mathue Baker, MD
  • Category: Heart Failure
  • Description: The purpose of this study is to determine the relationship between lactate in interstitial fluid (fluid found in the spaces around cells) as measured by Abbott’s investigational Continuous Lactate Monitoring (CLM) Sensor, in patients diagnosed with chronic heart failure (CHF) during a 90- day sensor wear period. This study is for research purposes only. There is no direct benefit from participating in the study. This study is for research purposes only. There is no direct benefit to you from your participation in the study.
  • Status: Currently enrolling

MARITIME-CV

  • Study Name: A study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity
  • Study Sponsor: Amgen, Inc
  • Principal Investigator: Keith Miller, MD
  • Category: Cardiovascular Disease and Obesity
  • Description: To reduce cardiovascular risk in adults with atherosclerotic cardiovascular disease and obesity (or overweight).
  • Status: Currently enrolling

Learn More About MARITIME-CV

MARITIME-HF

  • Study Name: A study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
  • Study Sponsor: Amgen, Inc
  • Principal Investigator: Keith Miller, MD
  • Category: Heart Failure and Obesity
  • Description: This study is being done to learn more about maridebart cafraglutide (MariTide) in people living with heart failure (HF) and obesity (overweight) in addition to their routine medical care.
  • Status: Currently enrolling

Learn More About MARITIME-HF

OCEAN(a) PreEvent

  • Study Name: A Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)
  • Study Sponsor: Amgen, Inc.
  • Principal Investigator: Chad Travers, MD
  • Category: Cardiovascular Disease
  • Description: To evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp[a]).
  • Status: Currently enrolling

Learn More About OCEAN(a) PreEvent

PREVENA 14 Day Study

  • Study Name: Trial Evaluating the Continuous Application of Prevena™ Therapy for up to 14 Days (when applied to sternotomies and vascular incisions)
  • Study Sponsor: KCI USA, Inc.
  • Principal Investigator: Ryan Shelstad, MD
  • Category: Blood, Heart and Circulation
  • Description: This study is being done to provide additional information to the FDA, in order to expand the current indication of the Prevena negative pressure dressing. It is currently approved for use up to 7 days, and the purpose of this study is to demonstrate similar benefits and risks when used continuously for up to 14 days. The dressing is applied in surgery on various incision types, with a return visit to the clinic to be removed around Day 14.
  • Status: Currently enrolling

Learn More About PREVENA 14 Day Study

TRANSFORM

  • Study Name: A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk-Factor Based Care for Primary Prevention of Cardiovascular Events
  • Study Sponsor: Cleerly, Inc.
  • Principal Investigator: Chad Travers, MD
  • Category: Metabolic Syndrome; Diabetes; Food, Nutrition and Weight; Wellness and Lifestyle
  • Description: This study is being done to compare two different strategies for preventing complications related to fatty build-up of plaque (also known as atherosclerosis) in the walls of the blood vessels supplying the heart, brain and legs. The current standard approach of risk factor-based prevention treats patients according to their risk factors for atherosclerosis (like cholesterol level and blood pressure) while the study-based care strategy adjusts treatment according to the visible amount of atherosclerosis seen in the blood vessels. A special x-ray, called a CCTA, will be obtained at the start of the study to determine the amount of atherosclerosis in the blood vessels.
  • Status: Currently enrolling

Learn More About TRANSFORM

V-INTERVENTION

  • Study Name: Evaluation of inclisiran versus placebo for the prevention of major adverse cardiovascular and limb events in patients undergoing percutaneous coronary intervention or peripheral endovascular intervention
  • Study Sponsor: Novartis Pharmaceuticals Corporation
  • Principal Investigator: Rajeev Anchan, MD
  • Category: Coronary and Peripheral Vascular Disease
  • Description: The purpose of this research study is to see if a study medicine called inclisiran can prevent major cardiovascular events (having to do with the heart or blood vessels), like heart attack or stroke, and leg events, like blockages in the vessels of your legs and related complications like amputation.
  • Status: Currently enrolling

Learn More About V-INTERVENTION