Research Studies

Protocol #: 20-2139

Location: Childrens Hospital Colorado

Protocol #: 20-1757

Location: Childrens Hospital Colorado

Protocol #: 20-1333

Location: Childrens Hospital Colorado

The purpose of the study is to test for validity and reliability in the revised Post Event Cardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event).

The purpose of the study is to test for validity and reliability in the revised Post EventCardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). The researchers plan to learn more about how individuals perceive their chance of developing certain cardiac risk factors after they have had a heart event such as after having a heart attack, or having cardiac surgery. If you join the study you will help us learn about: 1) what patients perceive their chance of developing certain cardiac risk factors, 2) how to structure cardiac rehab programs.

Protocol #: 20-6019

Location: Memorial Hospital Central

This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.

Protocol #: 20-6502

Location: Medical Center of the Rockies

Protocol #: 20-0820

Location: Childrens Hospital Colorado

While you are taking part in in the study, you will see your doctor as usual. Your doctor will make notes (medical records) about your disease and its treatment as he/she normally would. For the next 5 years, a study coordinator at your doctor’s office will collect information from your doctor’s notes about your medical condition and treatments, including any medication changes.

Protocol #: 19-6518

Locations: Memorial Hospital Central; Memorial Hospital North

Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood.1 There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study.

Protocol #: 20-0288

Location: University of Colorado Hospital

This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo. The objective of this investigation is to study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure treated with the HM3 LVAS.

Protocol #: 20-0254

Location: University of Colorado Hospital

Protocol #: 20-0104

Location: University of Colorado Hospital

Randomized, double-blind, placebo-controlled study of ION‑682884 vs. placebo administered by SC injection once every 4 weeks for 120 weeks in patients with ATTR-CM receiving available background SoC. Patients will be stratified at Randomization based on NYHA Classification (I and II vs. III), ATTR mutation status (mutated vs. wild-type), 6MWT (≤ 350 meters vs. > 350 meters), and current treatment with tafamidis (Yes vs. No). Study Drug (ION‑682884 or placebo) will be administered for 120 weeks (Treatment Period) followed by an additional 20 weeks of Post-Treatment Evaluation Period.

Protocol #: 19-2854

Location: University of Colorado Hospital

Protocol #: 19-2788

Location: University of Colorado Hospital

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation

Protocol #: 19-6129

Locations: Harmony Campus; Medical Center of the Rockies

Protocol #: 19-6114

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital

Protocol #: 15-1434

Location: Childrens Hospital Colorado

For Aim 1, this study will test: 1) the effects on quality of communication between patient and nurse, as measured by the patient, 2) the effect of the intervention on patient’s overall biopsychosocial and spiritual well-being, as measured by the PROMIS 29 profile, and 3) the effects on patient’s psychosocial illness impact, as measured by the PROMIS psychosocial illness impact. For Aim 2, this study will test acceptability, feasibility, and usability of the narrative intervention from the perspectives of the key stakeholders—patients with serious illness and acute-care bedside nurses via 1) patient and nurse exit interviews, 2) field analysis of EHR interface use, and 3) end-user usability surveys of the nurses.

Protocol #: 19-1874

Location: University of Colorado Hospital

The objective of this trial is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe TR who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with tricuspid valve surgery.

Protocol #: 19-1823

Location: University of Colorado Hospital

Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

To demonstrate the safety based on the incidence of early-onset (within 7 days of ablation procedure) primary adverse events. To demonstrate the 12-month effectiveness based on the proportion of subjects with freedom from documented asymptomatic and symptomatic Atrial Fibrillation, Atrial Tachycardia, or Atrial Flutter episodes

Protocol #: 19-6101

Locations: Harmony Campus; Medical Center of the Rockies

This clinical study is a prospective, multicenter, single-arm clinical evaluation of the Multi-Electrode Radiofrequency (RF) Balloon catheter. The purpose of this study is to evaluate the overall safety and effectiveness of the Multi-Electrode RF Balloon catheter, in conjunction with the Multi-Electrode Circular Diagnostic catheter and Multi-Channel RF Generator, for the treatment of drug refractory Paroxysmal Atrial Fibrillation (PAF). Embedded within the Main Study will be a Neurological Assessment Evaluable (NAE) subset and a Cardiac Computed Tomography (CT) or Magnetic Resonance Angiogram (MRA) image (CT/MRA) subset with consecutive enrollment and a prospective design. The same subject can participate in both the NAE and cardiac CT/MRA subsets. The study will enroll subjects with drug refractory, symptomatic PAF who are candidates for catheter ablation. The first 1-3 subjects for each ablating physician will be considered roll-in subjects to verify consistent workflow for study device components and to minimize any learning curve effects. The roll-in subjects will not be included in the NAE subset, cardiac CT/MRA subset, or in the primary endpoint analyses. The roll-in phase will include a maximum of 240 subjects and the main study phase will include a maximum of 400 evaluable subjects. Subjects will be evaluated prior to the procedure, prior to discharge, and post procedure at 7 days (7-14 days), 1 month (23-37 days), 3 months (76- 104 days), 6 months (150-210 days), and 12 months (315-405 days) unless otherwise specified in the protocol.

Protocol #: 19-1679

Location: University of Colorado Hospital

This is a clinical study sponsored by Amgen Inc. It is a study being done for patients that are at high risk for experiencing a cardiovascular event (like a heart attack or stroke). Elevated cholesterol, in particular low-density lipoprotein cholesterol (LDL-C), can lead to obstructing fatty deposits in blood vessels that can greatly increase the risk of developing cardiovascular disease or experiencing a cardiovascular event. The purpose of this research study is to assess whether lowering of cholesterol blood level can reduce your risk for major cardiovascular events (for example, heart attack or stroke) when evolocumab is taken in addition to current medical therapy as directed by a doctor, which may include a medication for the treatment of abnormal cholesterol blood levels called statins.

Protocol #: 19-6511

Location: Memorial Hospital Central

Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV.

Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV.

Protocol #: 19-1703

Location: University of Colorado Hospital

MEDLEY is a clinical study to research an investigational medicine for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe the investigational medication is and if it works as well as a medication already approved to protect against RSV. The study will include about 1500 babies globally. If you decide to take part, your baby may be in the MEDLEY Study for up to 2 years and may have up to 17 scheduled study visits. Your baby will be monitored throughout the study for respiratory illnesses.

Protocol #: 19-1403

Location: Childrens Hospital Colorado

This is a study for patients that have a heart condition in which the upper chambers of your heart beat irregularly. This condition, also known as atrial fibrillation, can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). Everyone has a LAA, which is like a pouch on the top of your heart, and it developed along with the other parts of the heart before birth. If a clot forms here, it can increase your chances of having a stroke or other related problems. Because you have atrial fibrillation, it is believed that if the LAA is closed, then blood clots might not be able to form in that area. The current standard of care to prevent stroke in patients with atrial fibrillation is long-term oral anticoagulation (OAC) therapy (blood thinner medication) or, in appropriately selected patients, implant of the commercial WATCHMANTM device followed by short-term OAC therapy.

Protocol #: 19-6506

Location: Memorial Hospital Central

The primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction [HFrEF], heart failure with preserved ejection fraction [HFpEF]), as well as athletes engaging in endurance/prolonged exercise, who are at a high risk of an acquired cardiomyopathy during/following completion of an endurance event.

Examine the heart function of elite athletes and heart failure patients utilizing a novel catheter system.

Protocol #: 19-1141

Location: University of Colorado Hospital

Test new MRI scanner sequences in diverse patient population

Protocol #: 19-0518

Location: Childrens Hospital Colorado

Protocol #: 19-0105

Location: Childrens Hospital Colorado

This is a 52 week blinded study in which the subject would recieve either Selexipag or Pacebo. Study visits are approximately every 6 to 12 weeks and study participants may be eligible for the open label extension at the end of 52 weeks.

Protocol #: 19-0347

Location: University of Colorado Hospital

LVAD registry

Protocol #: 18-2576B

Location: University of Colorado Hospital

This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Protocol #: 19-6030

Locations: Harmony Campus; Medical Center of the Rockies

The SURPOINT COA study is a prospective, multicenter, non-randomized post-market clinical evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF/ST catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A total of 330 subjects will be enrolled at up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and fifty (50) subjects will be treated with ST catheter. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Effectiveness and safety endpoints have been defined, and will be compared to predetermined performance goals. Subjects who sign the SURPOINT COA informed consent are considered enrolled in the study. Enrolled subjects who satisfy all eligibility criteria will then undergo the ablation procedure with the catheter and VISITAG SURPOINT™ Module. After the study ablation procedure, subjects will enter a 3-Month blanking period (Day 0-90). After the Blanking Period, subjects will enter the Evaluation Period (Days 91-365). Subjects having AF recurrence and/or receiving therapeutic interventions during the evaluation period will be considered effectiveness failures (refer to Section 4.1.1 for all effectiveness failure modes). All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of Treatments and Evaluations). Subjects complete the SURPOINT COA study after the 12-month follow up visit.

Protocol #: 19-0003

Location: University of Colorado Hospital

Adult patients with symptomatic clinically significant heart failure and elevated left atrial pressure despite guideline directed medical therapy (GDMT).

Protocol #: 18-2765

Location: University of Colorado Hospital

About 15,000 people will take part in this study. Half will get inclisiran injections and half will get dummy placebo) injections. A placebo is a substance that looks like a drug, but has no drug in it. This form will refer to both inclisiran and placebo as “study drug.” Which study drug you get is decided by chance and you will not know which study drug you are given. Joining the study involves 3 clinic visits in the first 5 months and then a visit every 6- months. At each visit a trained researcher will ask some questions about your health, take a blood sample, and give you an injection into your abdomen (tummy). It is expected that about 1 in 20 people administered inclisiran may notice some redness or soreness where the injection is given, but no other side effects have been found. However, at this stage, scientists cannot rule out the possibility of other side effects. You are asked to stay in the study for about 5 years.

Protocol #: 18-6511

Location: Memorial Hospital Central

This is a multicenter, randomized, blinded and placebo controlled study in subjects with WHO group 1 Pulmonary Arterial Hypertension who will recieve inhaled GB002 or matching placebo for 14 days. The subject will have to visit the clinic for screening and on days 1, 2, 8 and 14. The patient has the option of having a visiting nurse come to them on days 3 to 7 to verify that they are following instrctions for dosing of the study drug and completing their study diary correctly. There will also be a follow up telephone call on days 15 and 42 to assess the patient's physical status and record any additional medications being taken. On day 1 and day 14, the visit will last up to 6 hours and the patient will have 5 blood draws during that time to assess drug levels in the blood and on days 2 and 8, the visi will last up to 2 hours and the patient will have one blood level drawn on these days.

Protocol #: 18-2672

Location: University of Colorado Hospital

PASCAL System (vs. MitraClip) in treatment of symptomatic degenerative mitral regurgitation

Protocol #: 18-6126

Locations: Harmony Campus; Medical Center of the Rockies

LVAD registry

Protocol #: 18-2576A

Location: University of Colorado Hospital

Umbilical cord blood is collected at birth and shipped to ReGen Theranostics, Inc for manufacturing. The umbilical cord blood mononuclear cells (MNC) are isolated from the cord blood and frozen. The cells are then transported to the study site when the patient undergoes the Glenn surgery.

This study will evaluate the efficacy and safety of UCB-MNC intramyocardial injections performed during Stage II surgical palliation by focusing on short and long-term cardiac function leading up to the pre-op work-up for Stage III surgical palliation.

Protocol #: 18-2012

Location: Childrens Hospital Colorado

The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) from the time of randomization through 90 days in subjects with ACS (diagnosed with STEMI or NSTEMI)

Protocol #: 18-6081

Locations: Harmony Campus; Medical Center of the Rockies

The objective of the LESS-VT Clinical Trial is to demonstrate that substrate ablation with the FlexAbility SE catheter is safe and effective in reducing the occurrence of MMVT in patients in whom VT recurs despite antiarrhythmic drug therapy or when AAD are not tolerated or desired.

Protocol #: 18-1148

Location: University of Colorado Hospital

Participants will be randomly assigned to empagliflozin or placebo. Participants will take the study medication (empagliflozin or placebo) for 12 weeks.

Protocol #: 18-0926

Location: University of Colorado Hospital

Subjects enrolled in this trial will be randomly assigned to receive either Empagliflozin 10 mg or placebo for 12 weeks.

Protocol #: 18-0925

Location: University of Colorado Hospital

This study is a 34 week cross over study with a treatment period of 26 weeks. After screening criteria is met, the subject will receive either active drug or placebo, have a one week "washout" period in which the subject will not receive any medication, then the subject will have another 12 weeks of treatment. (If the subject received active drug in the first 12 weeks he/she will receive placebo during this 12 weeks and previous placebo subjects will receive active drug. Procedures that will be conducted during the study are: completion of quality of life questionnaires, EKGs, laboratory assessments, Pulmonary Function tests, and 6 minute walk tests. Each visit will take approximately 2 hours.

Protocol #: 18-0761

Location: University of Colorado Hospital

Protocol #: 16-6109-2N

Location: Medical Center of the Rockies

Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation Subjects will be assigned to either a surgical or a non-surgical arm, at the discretion of the local site heart team. Subjects must satisfy the trial inclusion/exclusion criteria, and be approved by the Subject Eligibility Committee (SEC), prior to inclusion in the trial. Surgical arm: Subjects whom the local site heart team determines are appropriate for mitral valve surgery will be randomized in a 2:1 ratio to the Tendyne device (Treatment group) or to standard of care surgical repair or total chordal-sparing surgical replacement (Control group). Randomization will be stratified by investigational site. Non-surgical arm: Subjects whom the local site heart team determines are not appropriate for mitral valve surgery and whose valve anatomy is not suitable for transcatheter repair, will be eligible to enroll into the non-surgical arm in which all subjects will receive the Tendyne device.

Protocol #: 18-0505

Location: University of Colorado Hospital

Protocol #: 18-6020

Location: Medical Center of the Rockies

This is a 3 month study to see if riociguat improves RHC measurements and exercise tolerance. There are 2 study visits - one at the beginning and one at the end - during which the subject will undergo a 6 MWT as well as a resting RHC and an exercise RHC. Study drug will be uptitrated at week 2, 4 and 6 via the telephone.

Protocol #: 17-2349

Location: University of Colorado Hospital

The purpose of this study is to test the safety and effectiveness of the study drug, avatrombopag, in subjects with thrombocytopenia undergoing an operation. Patients will receive either 60mg or 80mg of avatrombopag once daily by mouth for 5 days prior to surgery

Protocol #: 18-0546

Location: University of Colorado Hospital

The goals of this study are (1) to test the hypothesis that HR reduction is an important underlying antecedent for reverse remodeling, and (2) to identify components of the beta1-GSN responsible for reverse remodeling caused by HR reduction using ivabradine, which could allow for better drug targeting. This study will also yield hypothesis-generating data on whether ivabradine might be useful in earlier stage HFrEF patients than the current indication.

Protocol #: 16-1363

Location: University of Colorado Hospital

This study examines the use of stem cells to help the hearts of people who have heart failure as a result of a heart attack. Study subjects are randomized 3:2 to the treatment arm using the CardiAMP cell therapy system (Treatment Group) vs. a sham control. Subjects will be evaluated for 12 months thereafter to determine whether there is an improvement in walking distance, future heart attacks or hospitalizations, and/or survival.

Protocol #: 18-0158

Location: University of Colorado Hospital

This multinational Phase 3 study will evaluate the efficacy, safety and PK following treatment with ARRY-371797 compared with placebo (1:1 randomization) in at least 120 patients with NYHA functional Class II and III DCM secondary to LMNA mutations. NYHA functional Class IV patients (up to approximately 40) will ARRY-371797 (p38 MAP Kinase Inhibitor) Array BioPharma Inc. Clinical Study ARRAY-797-301 Protocol Version 2 7 Confidential 23 October 2017 also be enrolled (1:1 randomization) and will be assessed for overall safety and time from randomization to HF-related hospitalization or death due to any cause, in addition to PK and efficacy, if feasible. For the Class IV patients, some assessments (i.e., 6MWT, triplicate ECGs, echocardiograms (ECHO), arrhythmia, PK assessment and PD assessment) are considered optional based on whether the patient is ambulatory or not.

Protocol #: 17-2345

Locations: CTRC-adult; University of Colorado Hospital

Protocol #: 17-6134

Locations: Greeley Campus; Harmony Campus; Long's Peak Hospital; Longs Peak Hospital; Medical Center of the Rockies

Protocol #: 16-2506

Location: University of Colorado Hospital

Protocol #: 17-6209

Locations: Medical Center of the Rockies; Memorial Hospital Central

Protocol #: 16-0696

Location: University of Colorado Hospital

Protocol #: 17-1343

Location: University of Colorado Hospital

Protocol #: 17-1249

Locations: Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital

Protocol #: 17-1042

Location: University of Colorado Hospital

To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.

Protocol #: 17-6104

Locations: Harmony Campus; Medical Center of the Rockies

Protocol #: 17-0423

Location: University of Colorado Hospital

Protocol #: 17-0536

Location: University of Colorado Hospital

The purpose of this study is to learn more about where the fat tissue in your body originates. For many years it has been thought that all fat cells come from cells that are from the fat tissue itself, but now we know it is possible that some fat cells may originally come from the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells. You are being asked to be in this research study because you are a person over the age of 18 who has had a hematopoietic stem cell transplant or has chronic phase chronic myeloid leukemia (CML).

To understand if some fat cells (adipocytes) may originally come from cells in the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more unhealthy than other fat.

Protocol #: 13-0026

Location: University of Colorado Hospital

Protocol #: 16-1635

Locations: Colorado Research Center; CTRC-adult; University of Colorado Hospital