Non-invasive Assessment of Pulmonary Vascular Resistance in Elderly Patients With Chronic Obstructive Pulmonary Disease

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension; Cor Pulmonale

• Registration Number: NCT01554774
• Lead Sponsor: Hospital Viamed Valvanera, Spain

Brief Summary

Many studies have evaluated the viability of measuring the pulmonary vascular resistance (PVR) by non-invasive methods in patients with pulmonary hypertension, pulmonary thromboembolism, ischemic cardiopathy and valvular disease. The investigators have not found other studies which evaluate the PVR in elderly patients with COPD. The hypothesis is that in patients with COPD, the severity of obstruction, expressed by GOLD class, is associated with an increase of PVR.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-06
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• diagnosis of COPD stage II, III or IV according to the GOLD guidelines
• signed the informed consent

Exclusion Criteria

• ischemic cardiopathy
• severe valvular disease
• atrial fibrillation
• left bundle branch block

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
right ventricular function and GOLD stages	cross sectional	To compare right ventricular function, evaluated by a non-invasive method such as echocardiography, with the GOLD stages in chronic obstructive pulmonary disease (COPD) patients.

Secondary Outcome Measures

Name	Time	Method
Right ventricular function and FEV1.	cross sectional	Compare right ventricular function, evaluated by a non-invasive method such as echocardiography, tricuspid annulus plane systolic excursion (TAPSE),pulmonary artery systolic pressure (PAPs) and fractional area change (FAC), with the GOLD stages in chronic obstructive pulmonary disease (COPD) patients.
ECG and echocardiography parameters of cor pulmonale	cross sectional	The correlation between right ventricular function and the electrocardiographic parameters of cor pulmonale.
Right ventricle function and 6M-WT.	cross sectional	Evaluate the correlation between the hemodynamic indices of right ventricle and the six minute walking test (6M-WT).

Trial Locations

Locations (1)

Campus Bio-Medico University; 🇮🇹 Roma, Italy