Active Clinical Trials at CHI Health

Study Name: CATALYST

PI: Dr. Himanshu Agarwal

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

Study Name: CHAMPION-AF

Principal: Himanshu Agarwal, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: CHAMPION-AF

Description: The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Study Name: DAPA ACT HF-TIMI 68

Principal: Selma Mohammed, MD in Omaha

Anuradha Tunuguntla, MD in Lincoln

Category: Cardiovascular

Study Sites: CHI Health Clinic Heart Institute locations in Lincoln and Omaha

Description: This is an international, multicenter, parallel-group, randomized, double-blind, placebo-controlled trial in patients with heart failure with reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤40%) who have been stabilized during hospitalization for acute heart failure, evaluating the effect of in-hospital initiation of dapagliflozin versus placebo on the clinical outcome of cardiovascular death or worsening heart failure.

Study Name: INTERRUPT-AF

Principal: Peter Gallagher, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart - Lincoln

Description: To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.

Study Name: FINEARTS-HF

Principal: Steve Krueger, MD in Lincoln

Study Site: CHI Health Nebraska Heart – Lincoln

Principal: Douglas Kosmicki, MD in Grand Island

Study Site: CHI Health Nebraska Heart - Grand Island

Description: Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%

Study Name: V-INITIATE

Principal Investigator: Steven Krueger, MD

Category: Cardiovascular

Study Site: CHI Health Clinic Heart Institute Lincoln

Description: A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy

Study Name: OPT-ICD

Principal Investigator: Stephen Ackerman, MD

Category: Cardiovascular

Study Site: CHI Health Clinic Heart Institute Lincoln

Description: Observation of Patient Trends in electing to receive or not receive an ICD

Study Name: PROTECTED-TAVR

Principal: Himansu Agarwal, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Stroke PROTECTion with SEntinel During Transcatheter Aortic Valve Replacement.

Study Name: RELIEVE-HF

Principal Investigator – Steven Krueger, MD

Category – Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description – This study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional class III or ambulatory class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

Study Name: STEP-HFpEF DM 

Principal Investigator: Joseph Thibodeau, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

Study Name: STEP-HFpEF

Principal Investigator: Joseph Thibodeau, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Effect of semaglutide 2.4mg once weekly on function and symptoms in subjects with obesity-related HF with HFpEF

Study Name: WARRIOR

Principal: Arun Knamantha-Reddy, MBBS

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR).

Study Name: ZEUS

Principal Investigator: Steve Krueger, MD

Category: Cardiovascular

Study Site: CHI Health Clinic Heart Institute Lincoln

Description: A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation

Study Name: Cordio HearO (Cardiovascular)

Principal Investigator: Steven Krueger, MD

Category: Cardiovascular

Study Site: CHI Health Clinic Heart Institute Lincoln

Description: The research is being conducted to determine the ability of the Cordio HearO™️ mobile application system in early detection of worsening heart failure that may require intervention and to determine its performance. The Cordio HearO™️ is a software medical device that remotely monitors CHF patients by detecting changes in the patients' recorded voice relative to a baseline. The system is comprised of a mobile application (or "app") that is deployed on a mobile platform, and a web-based portal that enables caregivers to manage their patients.

Study Name: M14-431

Principal: Robert Kizer, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Biologic Therapy.

Study Name: EG-CL-101

Principal: Subhash Chandra, MD 

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per ACG guidelines.

Study Name: EG-CL-102

Principal: Subhash Chandra, MD 

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)

Study Name: Blue-C

Principal: Rajani Rangray, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)

Study Name: NASH 747-303 REGENERATE

Principal: Sandeep Mukherjee, MD

Category: Digestive Health

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Liver Disease Study

Description: Nonalcoholic steatohepatitis is when the liver is swollen and damaged from the build up of fat in the liver.  We are investigating the safety and efficacy of an oral drug to delay health-related conditions in patients with nonalcoholic steatohepatitis or evidence of liver fibrosis (damaged or scarred liver tissue).  

CHI Health participates in over 50 cancer clinical trials to find better ways to prevent, diagnose and treat cancer. Doctors use clinical trials to learn more about how to fight cancer. 

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Study Name: CHRONICLE

Principal Investigator: Bryan Krajicek, MD

Category: Pulmonary

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals with Severe Asthma in the United States.

Study Name: GC2006

Principal Investigator: Bryan Krajicek, MD

Category: Pulmonary

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The purpose of the study is to determine if liquid alpha1-proteinase inhibitor (human) (liquid alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus placebo plus SMT in hospitalized participants with COVID-19.

Study Name: GD001

Principal: Michael Feloney, MD, FACS

Category: Urology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Brief Summary: Semen Sample Collection and Processing for use in the Development of Prostate Cancer Diagnostic Tests.

A link is not available for this study.

Study Name: ACT

Principal: Michael Feloney, MD, FACS

Category: Urology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Brief Summary: A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.