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A randomized, sham-controLled, blinded (paTient and evaluators) Feasibility triaL Of the EdWards APTURE transcatheter shunt system
A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System... Protocol #23-1264 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, UCHealth - Scottsbluff, Yampa Valley Medical Center |
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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... Protocol #20-0254 Location: University of Colorado 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... Protocol #19-1874 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... Protocol #17-2345 Location: CTRC-adult, Outpatient CTRC, University of Colorado Hospital |
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The short-chain fatty acid acetate for improving age-associated arterial dysfunction
Specific Aim: To determine the following before and after 12 weeks of oral supplementation with calcium acetate vs. placebo (calcium citrate) in healthy men and women 50+ years of age: a) Endothelium-dependent dilation, assessed as brachial artery flow-mediated dilation (FMDBA) [primary o...more > Protocol #22-0473 |
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MitoQ supplementation for restoring aerobic exercise training effects on endothelial function in postmenopausal women
The purpose of this research study is to see if we can improve exercise training responses on heart health in postmenopausal women....more > Protocol #22-1521 |
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Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD).
Sargramostim is an investigational drug, meaning it has not been approved by the FDA to treat Alzheimer’s. Sargramostim has been approved by the FDA for the past thirty years to treat patients who have had chemotherapy to boost the body’s innate immune system. This research study hopes to ...more > Protocol #19-2727 |
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Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases
This is a prospective, multicenter phase II study designed to evaluate the outcomes of patients with bone marrow failure diseases (BMFD) undergoing HLA-matched related, HLA-matched unrelated, or single HLA-class 1 allele or HLA-DQB1 antigen or allele mismatched unrelated hematopoietic cell...more > Protocol #21-3994 Location: Childrens Hospital Colorado |
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ALLIANCE- Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
Prospective, single arm, multicenter study...more > Protocol #22-0486 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, UCHealth - Scottsbluff, Yampa Valley Medical Center |
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TELLTALE- NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
Transcatheter aortic valve implantation (TAVR) may cause life threatening coronary artery obstruction, whether implanted in native aortic stenosis or bioprosthetic aortic valve failure. Transmural Systems and NHLBI have developed a purpose-built electrosurgical guidewire system (TELLTAL...more > Protocol #22-0067 Location: Medical Center of the Rockies |
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The ROSIE Study
Two, in-person visits between 1-2 hours over approximately a 3-month period....more > Protocol #23-1234 |
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The ROSIE Study
Two, in-person visits between 1-2 hours over approximately a 3-month period....more > Protocol #23-1234 Location: Outpatient CTRC, University of Colorado Hospital |
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REACH - Role of microvascular insulin resistance and cardiorespiratory fitness in diabetes
Participants will undergo baseline testing of heart and blood vessel function as well as skeletal muscle function and exercise ability. Participants will then do cardiovascular exercise for 15 weeks, and all testing will be repeated....more > Protocol #20-2723 |
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REACH - Role of microvascular insulin resistance and cardiorespiratory fitness in diabetes
Participants will undergo baseline testing of heart and blood vessel function as well as skeletal muscle function and exercise ability. Participants will then do cardiovascular exercise for 15 weeks, and all testing will be repeated....more > Protocol #20-2723 Location: CTRC Inpatient, Outpatient CTRC, 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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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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Utilizing PCORnet to support transition from pediatric to adult centered care and reduce gaps in recommended care in patients with congenital heart disease
Understanding the impact of gaps in care on healthcare utilization, long-term co-morbidities, and patient reported outcomes are the highest priority topics from patients, families and researchers. Additionally, knowledge about the factors associated with these gaps in care was a key facto...more > Protocol #21-4668 Location: Childrens Hospital Colorado |
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Study of inflammatory Arthritis and Interstitial Lung Disease in Early Rheumatoid Arthritis: SAIL-RA
In this research study we want to learn more about rheumatoid arthritis (RA). Some people with rheumatoid arthritis develop a related condition called RA-associated interstitial lung disease (RA-ILD). We are doing this study to understand why some people with RA develop RA-ILD and others d...more > Protocol #21-4765 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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The Assessment of Long Term Durability, Safety and Effectiveness of the SAPIEN XT and SAPIEN 3 Transcatheter Heart Valve and Surgical Aortic
Valve Replacement in Intermediate Risk Patients Suffering from Severe
Symptomatic Aortic Stenosis
he PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control ar...more > Protocol #12-0660 Location: University of Colorado Hospital |
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Time and Nutrient-Dependent Effects of Aerobic Exercise on Metabolism in Adults with Obesity
If you are eligible to be in the study, you will perform baseline measures and then be assigned a randomized sequence of Fasted-AM exercise, Fed-AM exercise, Fasted-PM exercise, Fed-PM exercise. You will complete 5 consecutive days in each of these conditions across a ~5 month timeframe. ...more > Protocol #23-1388 Location: CTRC Inpatient |
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Does When You Exercise Matter? A Randomized Trial Comparing the Effect of Morning versus Evening Aerobic Exercise on Weight Loss and Compensatory Behaviors
If you join the study, you will undergo screening evaluations to see if you are eligible to be in the study. If you are eligible to be in the study, you will be randomized to one of two study groups. Which group you are assigned to will be chosen by chance by a procedure similar to the t...more > Protocol #21-3094 |
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Does When You Exercise Matter? A Randomized Trial Comparing the Effect of Morning versus Evening Aerobic Exercise on Weight Loss and Compensatory Behaviors
If you join the study, you will undergo screening evaluations to see if you are eligible to be in the study. If you are eligible to be in the study, you will be randomized to one of two study groups. Which group you are assigned to will be chosen by chance by a procedure similar to the t...more > Protocol #21-3094 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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A Double-Blinded, Placebo-Controlled, Randomized, 2 Period, Crossover Phase 1/2a Study to Test the Safety and Efficacy of Advair HFA (Salmeterol and Fluticasone) in Resting and Exercising Healthy and High Altitude Pulmonary Edema (HAPE) Predisposed Subjects
The study involves two separate study periods of 12 days each, where you will: • Take the study drug or placebo through a puffer for 7 days. You will not know which drug you are taking during which period • Wear a continuous heart monitor for 12 days • Have blood tests drawn during 5 vi...more > Protocol #23-0463 Location: CTRC Inpatient, Outpatient CTRC |
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PARTNER 3 VIV: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients with a Failing Aortic Bioprosthetic Valve
Protocol #17-6104 Location: Harmony Campus, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Yampa Valley Medical Center |
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Inspiring New Science in Guiding Healthcare in Turner Syndrome (INSIGHTS) Registry
Participants who join the INSIGHTS Registry are agreeing to have their medical records be used for research. There are no additional study visits, etc. – participants just continue with their usual clinical care. In addition to the basic registry, individuals can join a recruitment list f...more > Protocol #19-3027 Locations: Ann & Robert H. Lurie Children's Hospital of Chicago, Childrens Hospital Colorado, Childrens Hospital of Philadelphia, Childrens National Medical Center, University of North Carolina Children's Hospital, University of Texas Health Science Center at Houston |
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Menstrual profiles and cardiovascular disease risk among female adolescent athletes with and without menstrual irregularities
Participants will undergo a bone scan, 15 minutes of metabolic testing, and blood draw to assess markers of cardiovascular disease as well as hormone levels. ...more > Protocol #22-1372 Location: Childrens Hospital Colorado, Department Specific Free Standing Clinic, Outpatient CTRC |
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Optimizing pulsatility during cardiopulmonary bypass to reduce acute kidney injury: Prospective Observational Study
Blood, urine, and bone marrow will be collected to analyze biomarkers of acute kidney injury risk. Sublingual microscopy will be used to collect images in the mouth. This is to study the following aims: Aim 1: Determine the effect of pulsatility during CPB on endothelial function. We wil...more > Protocol #20-2465 Location: University of Colorado Hospital |
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CLASP II TR- Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial
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 Location: Harmony Campus, Medical Center of the Rockies |
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REDUCE Post Approval Study - GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO)
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 Location: Harmony Campus, Medical Center of the Rockies |
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Mitral Implantation of Transcatheter Valves
A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease...more > Protocol #23-0250 Location: Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |