[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07576894":3,"trial-entities:NCT07576894":123,"trial-summary:NCT07576894":128},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":40,"secondary_outcomes":45,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":96,"locations":99,"central_contacts":115,"overall_officials":118,"references":121,"see_also_links":122},"NCT07576894","23-0516b","Right Ventricular Response to Exercise Among Patients With Chronic Obstructive Pulmonary Disease","Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease","RECRUITING","2030-08-01","2026-05","2026-05-08","2025-08-01","University of Colorado, Denver","OTHER",true,"This study plans to learn more 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.","This study will determine patterns of right ventricular (RV) response to aerobic exercise in patients with chronic obstructive pulmonary disease (COPD) and will design a targeted exercise intervention to improve RV response. We will study 60 patients with COPD. Participants will complete cardiopulmonary exercise testing (CPET) and transthoracic echocardiography (TTE) during rest, moderate- and high-intensity exercise. A subset of participants (n=16) who have been recommended to undergo clinical right heart catheterization will be recruited for the primary study with additional invasive pressure-volume analysis during the CPET. This testing will be used to validate measures of RV function obtained through noninvasive testing. The sample size was selected based upon our preliminary data and statistical analysis plans.\n\nTo test whether an exercise intervention targeted to RV response to exercise is feasible for patients, 12 participants will complete a targeted exercise training intervention based on their RV contractile response during baseline testing. This intervention will include participants who demonstrate RV contractility increase to moderate- but not high-intensity exercise. We will test the feasibility of a moderate-intensity interval training program. Participants will complete exercise training sessions 3x\u002Fweek for 12 weeks. Exercise training will be performed on an upright stationary bicycle. Following the exercise training intervention, participants will repeat CPET and TTE. They will also complete a health-related quality of life questionnaire before and after the exercise training intervention.",[19,20,21,22,23],"COPD","Pulmonary Hypertension","Exercise","Right Ventricular (RV) Dysfunction","Exercise Training",[19,25,21,26,27],"Pulmonary hypertension","Pulmonary rehabilitation","Exercise training","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},60,"ESTIMATED",[36],{"type":37,"name":27,"description":38,"armGroupLabels":39},"BEHAVIORAL","Exercise training will include moderate-intensity interval training 3x\u002Fweek.",[19],[41],{"measure":42,"description":43,"timeFrame":44},"Right ventricular contractility measured by transthoracic echocardiography","Global longitudinal strain, measured in absolute percent","Up to 1 hour",[46,49,52,54,58,61,64],{"measure":47,"description":48,"timeFrame":44},"Right ventricular contractility measured by conductance catheter","Maximum rate of pressure change, dP\u002Fdtmax in mmHg\u002Fsec",{"measure":50,"description":51,"timeFrame":44},"Right ventricular systolic function measured by transthoracic echocardiography","Fractional area change on transthoracic echocardiography, measured in percent",{"measure":50,"description":53,"timeFrame":44},"Tricuspid annular plane systolic excursion on transthoracic echocardiography, measured in centimeters",{"measure":55,"description":56,"timeFrame":57},"Exercise training feasibility","Proportion of exercise training sessions completed","4 months",{"measure":59,"description":60,"timeFrame":57},"Exercise training safety","Adverse events, reported or observed",{"measure":62,"description":63,"timeFrame":44},"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":65,"description":66,"timeFrame":44},"Maximum oxygen consumption (VO2max)","In L\u002Fmin","ALL","40 Years",null,false,{"inclusion":72,"exclusion":75,"raw_text":95},[73,74],"COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \\[FEV1\u002FFVC\\] \\\u003C0.7)","Age \\>= 40 years",[76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94],"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%; uncontrolled 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 and\u002For 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 \\>35","Hematocrit \\\u003C25% or \\>55%","For subset undergoing right heart catheterization, chronic anticoagulation that is unable to be held for the study visit","For subset undergoing right heart catheterization or exercise training, forced expiratory volume in 1 second of \\\u003C20%","For exercise training, already engaged in routine exercise training (\\>30 minutes at \\>3 METs 3 times\u002Fweek or more)","For exercise training, inability to complete initial in-person exercise training sessions for approximately 35 minutes 3x\u002Fweek for 3 weeks (followed by exercise training sessions with an option for hybrid remote\u002Fin-person participation)","For exercise training with an option for hybrid remote exercise training, any medical conditions which threaten the safety of remote exercise training (e.g. imbalance\u002Fgait instability, etc.).","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%; uncontrolled 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 and\u002For 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 \\>35\n* Hematocrit \\\u003C25% or \\>55%\n* For subset undergoing right heart catheterization, chronic anticoagulation that is unable to be held for the study visit\n* For subset undergoing right heart catheterization or exercise training, forced expiratory volume in 1 second of \\\u003C20%\n* For exercise training, already engaged in routine exercise training (\\>30 minutes at \\>3 METs 3 times\u002Fweek or more)\n* For exercise training, inability to complete initial in-person exercise training sessions for approximately 35 minutes 3x\u002Fweek for 3 weeks (followed by exercise training sessions with an option for hybrid remote\u002Fin-person participation)\n* For exercise training with an option for hybrid remote exercise training, any medical conditions which threaten the safety of remote exercise training (e.g. imbalance\u002Fgait instability, etc.).",[97,98],"ADULT","OLDER_ADULT",[100],{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":112},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045","United States",[107],{"name":108,"role":109,"phone":110,"email":111},"Lindsay Forbes, MD","CONTACT","303-724-4020","lindsay.forbes@cuanschutz.edu",{"lat":113,"lon":114},39.72943,-104.83192,[116],{"name":108,"role":109,"phone":117,"email":111},"(303)724-4020",[119],{"name":108,"affiliation":13,"role":120},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":124,"biomarkers":127},[125,20,126],"Chronic Obstructive Pulmonary Disease","Right Ventricular Dysfunction",[],{"nct_id":4,"found":15,"summary":129,"prompt_version":139},{"design":130,"status":131,"heading":132,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is an interventional study with a planned enrollment of 60 participants. It will involve studying heart responses to exercise and a subset of participants will receive exercise training.","completed","Right Ventricular Response to Exercise in COPD Patients","This study aims to understand how the right side of your heart (right ventricle) responds to exercise if you have chronic obstructive pulmonary disease (COPD). Researchers want to identify different patterns of heart function during rest and exercise to help find better treatments for COPD patients in the future. You may be able to join if you are at least 40 years old and have COPD. The study will measure how well your right ventricle contracts using an echocardiogram (a type of ultrasound for the heart). The current recruitment status is unclear.","Right ventricular contractility will be measured up to 1 hour after certain procedures. The total follow-up duration for participants is not specified.",92,"Participants will complete cardiopulmonary exercise testing (CPET) and transthoracic echocardiography (TTE) during rest, moderate-, and high-intensity exercise. A subset of 12 participants will complete moderate-intensity interval training 3 times a week for 12 weeks.","Not stated in the trial record.",[],"v2"]