Non-invasive Assessment of Pulmonary Vascular Resistance in Elderly Patients With Chronic Obstructive Pulmonary Disease (PVR-COPD)

This study has been completed.
Sponsor:
Collaborator:
Campus Bio-Medico University
Information provided by (Responsible Party):
Vincenzo Malafarina, Hospital San Juan de Dios, Spain
ClinicalTrials.gov Identifier:
NCT01554774
First received: March 2, 2012
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Cor Pulmonale

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Hospital San Juan de Dios, Spain:

Primary Outcome Measures:
  • right ventricular function and GOLD stages [ Time Frame: cross sectional ] [ Designated as safety issue: No ]
    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:
  • Right ventricular function and FEV1. [ Time Frame: cross sectional ] [ Designated as safety issue: No ]
    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 [ Time Frame: cross sectional ] [ Designated as safety issue: No ]
    The correlation between right ventricular function and the electrocardiographic parameters of cor pulmonale.

  • Right ventricle function and 6M-WT. [ Time Frame: cross sectional ] [ Designated as safety issue: No ]
    Evaluate the correlation between the hemodynamic indices of right ventricle and the six minute walking test (6M-WT).


Enrollment: 60
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
GOLD II
Will be included in this group the patients with COPD stage II
GOLD III
Will be included in this group the patients with COPD stage III
GOLD IV
Will be included in this group the patients with COPD stage VI.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554774

Locations
Italy
Campus Bio-Medico University
Roma, Italy, 00128
Sponsors and Collaborators
Hospital San Juan de Dios, Spain
Campus Bio-Medico University
Investigators
Principal Investigator: Vincenzo Malafarina, MD Hospital San Juan de Dios, Spain
Study Director: Raffaele Antonelli Incalzi, MD Campus Bio-Medico University. S. Raffaele - Cittadella della Carità Foundation, Taranto, Italy
  More Information

Publications:

Responsible Party: Vincenzo Malafarina, MD, Hospital San Juan de Dios, Spain
ClinicalTrials.gov Identifier: NCT01554774     History of Changes
Other Study ID Numbers: HSJD-CBM-01
Study First Received: March 2, 2012
Last Updated: July 24, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Hospital San Juan de Dios, Spain:
COPD
PVR

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Heart Disease
Cardiovascular Diseases
Heart Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014