[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06195059":3,"trial-entities:NCT06195059":125,"trial-summary:NCT06195059":129},{"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":21,"study_type":22,"primary_purpose":17,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":36,"sex":85,"minimum_age":86,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":87,"std_ages":94,"locations":97,"central_contacts":118,"overall_officials":121,"references":123,"see_also_links":124},"NCT06195059","23-009478","Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume","Assessment of Pulmonary Blood Volume Using Contrast Echocardiography During Exercise","RECRUITING","2027-08","2026-08","2026-08-20","2024-07-30","Mayo Clinic","OTHER",false,"The purpose of this study is to evaluate whether pulmonary blood volume (PBV) derived from contrast echocardiography can serve as a non-invasive surrogate for invasive pulmonary artery wedge pressure (PAWP) during exercise. Also, to compare changes in PBV with exercise in patients with and without heart failure and pulmonary vascular disease.",null,[19,20],"Heart Failure","Pulmonary Vascular Disease",[],"OBSERVATIONAL",[],{"count":25,"type":26},800,"ESTIMATED",[],[29,33],{"measure":30,"description":31,"timeFrame":32},"Pulmonary Vascular Capacitance at Rest","Capacitance is defined as the total volume of blood in an organ or region at a given pressure. Pulmonary Vascular Capacitance (ml\u002FmmHg) will be determined by pulmonary blood volume\u002Fmean pulmonary artery pressure as measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.","Baseline",{"measure":34,"description":35,"timeFrame":32},"Pulmonary Vascular Capacitance During Exercise","Capacitance is defined as the total volume of blood in an organ or region at a given pressure. Pulmonary Vascular Capacitance (ml\u002FmmHg) will be determined by pulmonary blood volume\u002Fmean pulmonary artery pressure as measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.",[37,40,43,46,49,52,55,58,61,64,67,70,73,76,79,82],{"measure":38,"description":39,"timeFrame":32},"Pulmonary Blood Volume at Rest","Pulmonary blood volume (ml) is measured by measuring indicator dilution curves using sonographic contrast at rest during the standard of care exercise hemodynamic assessment.",{"measure":41,"description":42,"timeFrame":32},"Pulmonary Blood Volume During Exercise","Pulmonary blood volume (ml) is measured by measuring indicator dilution curves using sonographic contrast during the exercise portion of the standard of care exercise hemodynamic assessment.",{"measure":44,"description":45,"timeFrame":32},"Pulmonary Vascular Compliance at Rest","Compliance is the change in volume for a given change in pressure. Pulmonary Vascular Compliance (ml\u002FmmHg) is defined as stroke volume divided by Pulmonary Artery (PA) pulse pressure and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.",{"measure":47,"description":48,"timeFrame":32},"Pulmonary Vascular Compliance During Exercise","Compliance is the change in volume for a given change in pressure. Pulmonary Vascular Compliance (ml\u002FmmHg) is defined as stroke volume divided by Pulmonary Artery (PA) pulse pressure and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.",{"measure":50,"description":51,"timeFrame":32},"Right Atrial Pressure at Rest","Right Atrial Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.",{"measure":53,"description":54,"timeFrame":32},"Right Atrial Pressure During Exercise","Right Atrial Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.",{"measure":56,"description":57,"timeFrame":32},"Right Ventricular Pressure at Rest","Right Ventricular Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.",{"measure":59,"description":60,"timeFrame":32},"Right Ventricular Pressure During Exercise","Right Ventricular Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.",{"measure":62,"description":63,"timeFrame":32},"Pulmonary Artery Pressure at Rest","Pulmonary Artery Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.",{"measure":65,"description":66,"timeFrame":32},"Pulmonary Artery Pressure During Exercise","Pulmonary Artery Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.",{"measure":68,"description":69,"timeFrame":32},"Pulmonary Capillary Wedge Pressure at Rest","Pulmonary capillary wedge pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.",{"measure":71,"description":72,"timeFrame":32},"Pulmonary Capillary Wedge Pressure During Exercise","Pulmonary capillary wedge pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.",{"measure":74,"description":75,"timeFrame":32},"Cardiac Output at Rest","Cardiac output (L\u002Fmin) is the total volume of blood moved by the heart per minute and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.",{"measure":77,"description":78,"timeFrame":32},"Cardiac Output During Exercise","Cardiac output (L\u002Fmin) is the total volume of blood moved by the heart per minute and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.",{"measure":80,"description":81,"timeFrame":32},"Pulmonary Vascular Resistance at Rest","Pulmonary vascular resistance (PVR) is the resistance against blood flow from the pulmonary artery to the left atrium. PVR (in Wood units) will be measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.",{"measure":83,"description":84,"timeFrame":32},"Pulmonary Vascular Resistance During Exercise","Pulmonary vascular resistance (PVR) is the resistance against blood flow from the pulmonary artery to the left atrium. PVR (in Wood units) will be measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.","ALL","18 Years",{"inclusion":88,"exclusion":90,"raw_text":93},[89],"Patients referred to the cardiac catheterization laboratory for invasive exercise right heart catheterization for evaluating exertional dyspnea. Investigators will include patients with normal or low EF, and across the spectrum of pulmonary hypertension severity.",[91,92],"Patient inability or unwillingness to undergo echocardiography including a contrast method, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case.","Prior adverse reaction to echo contrast administration","Inclusion Criteria:\n\n* Patients referred to the cardiac catheterization laboratory for invasive exercise right heart catheterization for evaluating exertional dyspnea. Investigators will include patients with normal or low EF, and across the spectrum of pulmonary hypertension severity.\n\nExclusion Criteria:\n\n* Patient inability or unwillingness to undergo echocardiography including a contrast method, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case.\n* Prior adverse reaction to echo contrast administration",[95,96],"ADULT","OLDER_ADULT",[98],{"facility":99,"status":8,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":115},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[105,109,113],{"name":106,"role":107,"phone":108},"Circulatory Failure Research Team","CONTACT","507-255-2200",{"name":110,"role":107,"phone":111,"email":112},"Barry Borlaug, MD","507-255-2142","Borlaug.Barry@mayo.edu",{"name":110,"role":114},"PRINCIPAL_INVESTIGATOR",{"lat":116,"lon":117},44.02163,-92.4699,[119,120],{"name":106,"role":107,"phone":108},{"name":110,"role":107,"phone":111,"email":112},[122],{"name":110,"affiliation":13,"role":114},[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[19,127],"Pulmonary Vascular Disorder",[],{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an observational study planning to include 800 participants. It is not testing a new treatment, but rather observing and comparing existing diagnostic methods.","completed","Observational Study on Contrast Echocardiography for Heart Failure and Pulmonary Vascular Disease","This study is looking at whether a non-invasive test called contrast echocardiography (an ultrasound of the heart using a special dye) can measure the amount of blood in your lungs (pulmonary blood volume, or PBV) as accurately as an invasive procedure called pulmonary artery wedge pressure (PAWP) during exercise. Researchers also want to see how PBV changes during exercise in people with and without heart failure and pulmonary vascular disease. You might be able to join if you are 18 or older, referred for an invasive exercise right heart catheterization to evaluate shortness of breath during activity, and have normal or low heart function, and any severity of pulmonary hypertension. The study aims to see if PBV measured at rest and during exercise can be a good indicator of how well your lungs are working. The current recruitment status is unclear.","Not specified.",141,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]