Clinical trial NCT01554774: Non-invasive Assessment of Pulmonary Vascular Resistance in Elderly Patients With Chronic Obstructive Pulmonary Disease
Official title: Observational Study of Comparison of Echocardiographic Markers of Right Ventricular Function and Electrocardiographic Signs of Chronic Cor Pulmonale in Elderly Patient With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Cor Pulmonale
Keywords: COPD
PVR
Lead sponsor: Hospital Viamed Valvanera, Spain
Sponsor class: OTHER
Collaborators: name: Campus Bio-Medico University
First posted: 2012-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive series of patients with a diagnosis of COPD who were treated in the consulting rooms of the department of respiratory physiopathology.

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.


Eligibility criteria: 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

Primary outcomes:
measure: right ventricular function and GOLD stages
timeFrame: cross sectional
Secondary outcomes:
measure: Right ventricular function and FEV1.
timeFrame: cross sectional
measure: ECG and echocardiography parameters of cor pulmonale
timeFrame: cross sectional
measure: Right ventricle function and 6M-WT.
timeFrame: cross sectional
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Campus Bio-Medico University
Study officials:
affiliation: Hospital Viamed Valvanera, Spain
name: Vincenzo Malafarina, MD MSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Campus Bio-Medico University. S. Raffaele - Cittadella della Carità Foundation, Taranto, Italy
name: Raffaele Antonelli Incalzi, MD
role: STUDY_DIRECTOR
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