Tokyo, Nov. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059694) titled 'An Exploratory Study on the Relationship Between Right Ventricular Isovolumic Relaxation Time, Pulmonary Vascular Load, and Clinical Outcomes in Patients with COPD' on Nov. 12.

Study Type: Observational

Primary Sponsor: Institute - Nippon Medical School Hospital

Condition: Condition - Chronic Obstructive Pulmonary Disease (COPD) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to determine whether right ventricular isovolumetric relaxation time (IRT) obtained by echocardiography can serve as a noninvasive indicator of pulmonary vascular resistance (PVR) measured by right heart catheterization in patients with Chronic Obstructive Pulmonary Disease (COPD) Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Adults aged between 20 and 80 years.

Patients diagnosed with chronic obstructive pulmonary disease (COPD) by respiratory specialists according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.

Clinically stable condition for at least 3 months, with no need for treatment modification.

Underwent both echocardiographic and right heart catheterization (RHC) examinations for the evaluation of exertional dyspnea.

Complete and analyzable clinical, echocardiographic, and hemodynamic data available. Key exclusion criteria - Patients were excluded if they met any of the following criteria:

Pulmonary hypertension (PH) caused by etiologies other than COPD (e.g., interstitial lung disease, pulmonary embolism).

Left heart disease defined as left ventricular ejection fraction (LVEF) 15 mmHg.

Treatment with systemic vasodilators or calcium channel blockers, or recent use of these agents.

Comorbid conditions unrelated to COPD that significantly limit physical activity (for example, neuromuscular or orthopedic disorders).

Incomplete hemodynamic or echocardiographic data or missing essential parameters.

Clinical features suggesting asthma or asthma COPD overlap (ACO), including:

Bronchodilator reversibility in FEV1 greater than or equal to 200 mL,

Blood eosinophil count greater than 150 cells per micro liter,

History of atopy, or

Serum IgE level greater than 170 IU per mL.

Atrial fibrillation or significant arrhythmias that make time interval measurement difficult.

Combined pulmonary fibrosis and emphysema (CPFE) defined as fibrotic changes occupying more than 10 percent of total lung field on high resolution computed tomography (HRCT).

Patients with minimal paraseptal fibrosis or traction bronchiectasis involving less than 10 percent of the lung field were included. Target Size - 60

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2021 Year 04 Month 01 Day Date of IRB - 2025 Year 10 Month 01 Day Anticipated trial start date - 2021 Year 04 Month 01 Day Last follow-up date - 2025 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068278

Disclaimer: Curated by HT Syndication.