[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05896579":3,"trial-entities:NCT05896579":114,"trial-summary:NCT05896579":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":24,"primary_purpose":13,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":35,"secondary_outcomes":40,"sex":62,"minimum_age":63,"maximum_age":16,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":87,"locations":90,"central_contacts":106,"overall_officials":109,"references":112,"see_also_links":113},"NCT05896579","23-0516","Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease","RECRUITING","2030-08","2026-05","2026-05-08","2023-08-22","University of Colorado, Denver","OTHER",true,"This study plans to learn about heart function among individuals with chronic obstructive pulmonary disease (COPD). In particular, the investigators want to understand the different patterns of right ventricular response during rest and moderate- vs high-intensity exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.",null,[18,19,20,21,22],"COPD","Pulmonary Hypertension","Right Ventricular Dysfunction","Exercise","Exercise Training",[],"INTERVENTIONAL",[26],"NA",{"count":28,"type":29},60,"ESTIMATED",[31],{"type":32,"name":21,"description":33,"armGroupLabels":34},"BEHAVIORAL","After a brief warmup, participants will be asked to perform approximately 5 minutes of exercise at moderate intensity and then approximately 2 minutes of exercise at high intensity.",[18],[36],{"measure":37,"description":38,"timeFrame":39},"Right ventricular contractility measured by transthoracic echocardiography","Global longitudinal strain, measured in absolute percent","Up to 1 hour",[41,44,47,49,52,55,58],{"measure":42,"description":43,"timeFrame":39},"Right ventricular contractility measured by conductance catheter","Maximum rate of pressure change, dP\u002Fdtmax in mmHg\u002Fsec",{"measure":45,"description":46,"timeFrame":39},"Right ventricular systolic function measured by transthoracic echocardiography","Fractional area change on transthoracic echocardiography, measured in percent",{"measure":45,"description":48,"timeFrame":39},"Tricuspid annular plane systolic excursion on transthoracic echocardiography, measured in centimeters",{"measure":50,"description":51,"timeFrame":39},"Health-related quality of life by Short Form 36 (SF-36) questionnaire","Units, range 0-100 with greater scores indicating a more favorable health state",{"measure":53,"description":54,"timeFrame":39},"Maximum oxygen consumption (VO2max)","In L\u002Fmin",{"measure":56,"description":57,"timeFrame":39},"Plasma acylcarnitines measured via ultra-high-performance liquid chromatography coupled to mass spectrometry","Peak intensity, measured as arbitrary units",{"measure":59,"description":60,"timeFrame":61},"Physical activity measured by activity monitor","Time spent in moderate or vigorous activity in absolute percent","7 days","ALL","40 Years",false,{"inclusion":66,"exclusion":69,"raw_text":86},[67,68],"COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \\[FEV1\u002FFVC\\] \\\u003C0.7)","Age \\>= 40 years",[70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85],"Exacerbation of COPD in the 3 months prior to enrollment","Change in COPD therapy in the 3 weeks prior to enrollment","Requirement of \\>6 LPM supplemental oxygen at rest","Requirement of \\>10 LPM supplemental oxygen with exertion","Active\u002Funcontrolled cardiovascular disease (e.g. hypertension with blood pressure \\>150\u002F100 despite antihypertensives; coronary artery disease with angina; left ventricular ejection fraction ≤40%; arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mild in severity; tricuspid regurgitation greater than moderate in severity)","Volume overload (jugular vascular distension or greater than trace peripheral edema)","World Health Organization Functional Class IV","Known pulmonary hypertension with mean pulmonary artery pressure \\>45 mmHg","Untreated severe obstructive sleep apnea or obesity hypoventilation syndrome","Active malignancy (other than skin)","Medical conditions that limit exercise on an upright stationary bicycle (e.g. severe osteoarthritis, imbalance\u002Fgait instability, etc.)","Pregnancy","Body mass index \\\u003C18 or \\>40","Hematocrit \\\u003C25% or \\>55%","For invasive CPET, chronic anticoagulation that is unable to be held for the study visit","For invasive CPET, forced expiratory volume in 1 second of \\\u003C20%","Inclusion Criteria:\n\n* COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \\[FEV1\u002FFVC\\] \\\u003C0.7)\n* Age \\>= 40 years\n\nExclusion Criteria:\n\n* Exacerbation of COPD in the 3 months prior to enrollment\n* Change in COPD therapy in the 3 weeks prior to enrollment\n* Requirement of \\>6 LPM supplemental oxygen at rest\n* Requirement of \\>10 LPM supplemental oxygen with exertion\n* Active\u002Funcontrolled cardiovascular disease (e.g. hypertension with blood pressure \\>150\u002F100 despite antihypertensives; coronary artery disease with angina; left ventricular ejection fraction ≤40%; arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mild in severity; tricuspid regurgitation greater than moderate in severity)\n* Volume overload (jugular vascular distension or greater than trace peripheral edema)\n* World Health Organization Functional Class IV\n* Known pulmonary hypertension with mean pulmonary artery pressure \\>45 mmHg\n* Untreated severe obstructive sleep apnea or obesity hypoventilation syndrome\n* Active malignancy (other than skin)\n* Medical conditions that limit exercise on an upright stationary bicycle (e.g. severe osteoarthritis, imbalance\u002Fgait instability, etc.)\n* Pregnancy\n* Body mass index \\\u003C18 or \\>40\n* Hematocrit \\\u003C25% or \\>55%\n* For invasive CPET, chronic anticoagulation that is unable to be held for the study visit\n* For invasive CPET, forced expiratory volume in 1 second of \\\u003C20%",[88,89],"ADULT","OLDER_ADULT",[91],{"facility":92,"status":7,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":103},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045","United States",[98],{"name":99,"role":100,"phone":101,"email":102},"Lindsay Forbes, MD","CONTACT","303-724-4020","lindsay.forbes@cuanschutz.edu",{"lat":104,"lon":105},39.72943,-104.83192,[107],{"name":99,"role":100,"phone":108,"email":102},"(303)724-4020",[110],{"name":99,"affiliation":12,"role":111},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":115,"biomarkers":117},[116,21,19,20],"Chronic Obstructive Pulmonary Disease",[],{"nct_id":4,"found":14,"summary":119,"prompt_version":129},{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study planning to enroll 60 participants to observe their heart function during exercise.","completed","Understanding Heart Function in COPD Patients","This study is looking for people aged 40 and older with chronic obstructive pulmonary disease (COPD) to understand how their heart, specifically the right ventricle, works during rest and exercise. You would participate in an exercise session involving moderate and high-intensity activity. Researchers will use an echocardiogram (a type of ultrasound for the heart) to measure how well your right ventricle contracts during this time. The goal is to identify different patterns of right ventricular dysfunction to help find better treatments for COPD in the future. The study plans to enroll 60 participants, and its current recruitment status is unclear.","Right ventricular contractility is measured up to 1 hour after the intervention.",100,"After a brief warm-up, you will perform about 5 minutes of moderate-intensity exercise and then about 2 minutes of high-intensity exercise. Your right ventricular contractility will be measured by echocardiography for up to 1 hour.","Not stated in the trial record.",[21],"v2"]