umeclidinium bromide, vilanterol for Chronic obstructive pulmonary disease | Heart failure (left ventricular ejection fraction 35-50%) | Heart failure (left ventricular ejection fraction 35-55%)

Inclusion criteria

• {"criterion_text":"- Patients aged at least 40 years with a clinical diagnosis of COPD\n- Airflow limitation indicated by a screening post-bronchodilator FEV1 of less than 80% predicted and a post-bronchodilator FEV1 to forced vital capacity (FVC) ratio of less than 0.7\n- Smoking history of at least ten pack-years\n- Baseline lung hyperinflation with a residual volume of more than 135% predicted\n- Stable heart failure\n- Left ventricle ejection fraction in the range of 35% to 55%\n- A suitable ultrasonic window from the apical view"}

Exclusion criteria

• {"criterion_text":"- Do not sign the informed consent\n- Unstable cardiovascular diseases\n- Atrial fibrillation or other arrhythmias requiring treatment\n- Unstable ischemic heart disease\n- Uncontrolled hypertension\n- Patients unable to undergo cardiac MR scanning (claustrophobia or carrying non MR-compatible devices)\n- Patients unable to perform exercise test (locomotor conditions)\n- Inadequate ultrasound window from the apical view"}

Primary endpoints

• {"endpoint_text":"- Baseline-corrected, time-velocity integral (a direct surrogate of SV) during peak exercise, as measured by exercise Doppler-echocardiography (last satisfactory measurement)","definition_or_measurement_approach":"Measured by exercise Doppler-echocardiography; baseline-corrected time-velocity integral used as a direct surrogate of stroke volume; last satisfactory measurement used."}
• {"endpoint_text":"- Maximal oxygen pulse on a cardiopulmonary exercise test on cycle-ergometer","definition_or_measurement_approach":"Assessed during a cardiopulmonary exercise test on a cycle-ergometer; maximal oxygen pulse measured during the test."}

Secondary endpoints

• {"endpoint_text":"- Resting lung volumes ( Inspiratory capacity, functional residual capacity and residual volume)","definition_or_measurement_approach":"Resting lung volumes including inspiratory capacity, functional residual capacity and residual volume measured (method not further specified in the record)."}
• {"endpoint_text":"- Inspiratory Capacity every 2 minutes during the incremental exercise test","definition_or_measurement_approach":"Inspiratory capacity measured every 2 minutes during the incremental exercise test."}
• {"endpoint_text":"- Left and right cardiac chambers volumes at rest in patients, as measured by MRI","definition_or_measurement_approach":"Cardiac chamber volumes measured at rest by MRI."}
• {"endpoint_text":"- Baseline-corrected peak ejection intraventricular pressure difference (peak EIVPD) at peak exercise, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement)","definition_or_measurement_approach":"Measured by exercise color-Doppler M-mode echocardiography; baseline-corrected peak EIVPD at peak exercise; last satisfactory measurement used."}
• {"endpoint_text":"- Pulmonary acceleration time in the main pulmonary artery as measured by phase-contrast MRI","definition_or_measurement_approach":"Measured by phase-contrast MRI in the main pulmonary artery."}
• {"endpoint_text":"- Baseline-corrected peak intraventricular diastolic pressure gradient (peak DIVPD) at peak exercise – diastolic suction, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement)","definition_or_measurement_approach":"Measured by exercise color-Doppler M-mode echocardiography; baseline-corrected peak DIVPD at peak exercise; last satisfactory measurement used."}
• {"endpoint_text":"- ProBNP levels","definition_or_measurement_approach":"Measurement of ProBNP blood levels (assay method not specified)."}
• {"endpoint_text":"- Average changes in COPD Assessment Test (CAT) and Transition dyspnea index","definition_or_measurement_approach":"Patient-reported outcomes using the COPD Assessment Test (CAT) and Transition Dyspnea Index; average changes from baseline assessed."}
• {"endpoint_text":"- Proportion of patients with Clinically relevant changes in COPD Assessment Test (CAT) and Transition dyspnea index ( -4 and -2 respectively)","definition_or_measurement_approach":"Proportion of patients achieving clinically relevant changes defined as -4 for CAT and -2 for Transition Dyspnea Index."}

Spain

Earliest CTIS Part Ii Submission Date

06-11-2024

Latest Decision Or Authorization Date

20-11-2024

Processing Time Days

14

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Hospital General Universitario Gregorio Maranon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain