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Protocol A011-13 (HYPERION): A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients
Protocol #: 21-3600 Location: University of Colorado Hospital |
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A Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous Clustered Regularly Interspaced Short Palindromic Repeats Gene-edited CD34+ Human Hematopoietic Stem and Progenitor Cells (EDIT-301) in Subjects with Severe Sickle Cell Disease
Protocol #: 20-2626 Location: Childrens Hospital Colorado |
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Protocol A011-11 (STELLAR): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
Protocol #: 20-2581 Location: University of Colorado Hospital |
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A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants (from 1 month to < 18 years of age) with Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplantation (HSCT)
Protocol #: 20-2471 Location: Childrens Hospital Colorado |
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A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months
Protocol #: 20-2082 Location: Childrens Hospital Colorado |
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune
Thrombocytopenia (ITP)
Protocol #: 20-2156 Location: Childrens Hospital Colorado |
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An open-label, repeat-application, intra-subject, dose escalation (Part 1) followed by a randomized, double-blind, placebo-controlled (Part 2) trial of topical VT30 in subjects with venous, lymphatic or mixed malformations associated with PIK3CA or TEK genetic mutations
Protocol #: 20-1757 Location: Childrens Hospital Colorado |
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Post Event-Cardiovascular Risk Perception Survey (PE-CRPS): Validity and Reliability in Cardiac Patients Post Heart Event
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). ...more > Protocol #: 20-6019 Location: Memorial Hospital Central |
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Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
This study is designed to collect a repository of resting phase signals from eligible subjects prior to right heart catheterization using the Phase Signal Recorder (PSR) for the purpose of development, testing and optimization of algorithms in the general population. ...more > Protocol #: 20-6505 Locations: Memorial Hospital Central; Memorial Hospital North |
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Myocardial Virus and Gene Expression in SARS CoV-2 Positive Patients ?with Clinically Important Myocardial Dysfunction
This study plans to learn more about coronavirus infection in the heart. We wish to investigate whether the coronavirus that causes COVID-19 directly infects heart muscle tissue, and if so, how this might occur. The hope is that once we better understand how this process occurs, that we ma...more > Protocol #: 20-0852 Location: University of Colorado Hospital |
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OPTIMIZE PAD-1: Implementation of Vascular Care Team to Improve Medical Management of PAD Patients
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 c...more > Protocol #: 20-0288 Location: University of Colorado Hospital |
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Prospective, randomized, double-blinded, placebo-controlled clinical investigation 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
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 o...more > Protocol #: 20-0254 Location: University of Colorado Hospital |
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Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): 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
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 reg...more > Protocol #: 19-6129 Locations: Harmony Campus; Medical Center of the Rockies |
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Microfluidic models of bleeding and thrombosis
This study plans to learn more about how blood composition affects the formation of blood clots and to identify how individuals respond to commons drugs like anticoagulants and hormone treatments. ...more > Protocol #: 19-2408 Locations: Department Specific Free Standing Clinic; Hemophilia and Thrombosis Center (HTC); University of Colorado Hospital |
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A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (AURIGA)
Protocol #: 19-6114 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
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Personalized experiences to inform improved communication for patients with Life Limiting Illness
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 pa...more > Protocol #: 19-1874 Location: University of Colorado Hospital |
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Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal (TRILUMINATE Pivotal)
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 t...more > Protocol #: 19-1823 Location: University of Colorado Hospital |
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Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation...more > Protocol #: 19-6101 Locations: Harmony Campus; Medical Center of the Rockies |
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A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
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....more > Protocol #: 19-1403 Location: Childrens Hospital Colorado |
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Cardiopulmonary and Right Ventricular Function in Health and Disease
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...more > Protocol #: 19-1141 Locations: CTRC Inpatient; University of Colorado Hospital |
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SELECT: SELExipag in inoperable or persistent/recurrent Chronic Thromboembolic pulmonary hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension.
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. ...more > Protocol #: 19-0347 Location: University of Colorado Hospital |
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GORE? CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
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....more > Protocol #: 19-6030 Locations: Harmony Campus; Medical Center of the Rockies |
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Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System
Adult patients with symptomatic clinically significant heart failure and elevated left atrial pressure despite guideline directed medical therapy (GDMT)....more > Protocol #: 18-2765 Location: University of Colorado Hospital |
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A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease
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 dru...more > Protocol #: 18-6511 Location: Memorial Hospital Central |
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Destination Therapy Post Approval Study - Medtronic HVAD System
LVAD registry...more > Protocol #: 18-2576A Location: University of Colorado Hospital |
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Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells during Stage II Surgical Repair of Hypoplastic Left Heart Syndrome (Auto Cell-II)
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. ...more > Protocol #: 18-2012 Location: Childrens Hospital Colorado |
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A phase II pilot trial to estimate survival after a non-total body irradiation (TBI) based conditioning regimen in patients diagnosed with B-acute lymphoblastic leukemia (ALL) who are pre-allogeneic hematopoietic cell transplantation (HCT) next-generation-sequence (NGS) minimal residual disease (MRD) negative
Protocol #: 18-1893 Location: Childrens Hospital Colorado |
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PERFECT: A Phase 3, Randomized. Placebo-Controlled, Double Blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)
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 ...more > Protocol #: 18-0761 Location: University of Colorado Hospital |
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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) (the "trial")
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 hea...more > Protocol #: 18-0505 Location: University of Colorado Hospital |
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Aquaman: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendoarterectomy
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 we...more > Protocol #: 17-2349 Locations: Outpatient CTRC; University of Colorado Hospital |
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Pulse Reduction on Beta Blocker and Ivabradine Therapy (PROBE-IT)
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 dr...more > Protocol #: 16-1363 Location: University of Colorado Hospital |
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Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Post Myocardial Infarction Heart Failure
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 1...more > Protocol #: 18-0158 Location: University of Colorado Hospital |
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A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutations
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 (u...more > Protocol #: 17-2345 Locations: CTRC-adult; Outpatient CTRC; University of Colorado Hospital |
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EARLY-TAVR Evaluation of Transcatheter Aortic Valve
Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis
Protocol #: 17-6134 Locations: Greeley Campus; Harmony Campus; Long's Peak Hospital; Longs Peak Hospital; Medical Center of the Rockies; Yampa Valley Medical Center |
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A clinical trial of an Electronic health record-leveraged, Patient-centered, Intensification of Chronic care for Heart Failure (EPIC-HF) patient engagement video and medication options checklist
Protocol #: 17-1249 Locations: Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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PARTNER 3: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing
Protocol #: 17-6104 Locations: Harmony Campus; Long's Peak Hospital; Medical Center of the Rockies; Yampa Valley Medical Center |