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OpenTrials
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NCT Number: NCT01554774

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Cardiovascular Diseases Chronic Disease Cor Pulmonale Disease Attributes Heart Diseases Hypertension Hypertension, Pulmonary Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Heart Disease Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Campus Bio-Medico University

Roma, Italy, 00128

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. right ventricular function and GOLD stages

    Time frame: 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 outcomes

  1. Right ventricular function and FEV1.

    Time frame: 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.

  2. ECG and echocardiography parameters of cor pulmonale

    Time frame: cross sectional

    The correlation between right ventricular function and the electrocardiographic parameters of cor pulmonale.

  3. Right ventricle function and 6M-WT.

    Time frame: cross sectional

    Evaluate the correlation between the hemodynamic indices of right ventricle and the six minute walking test (6M-WT).

Sponsors and collaborators

Lead sponsor

Hospital Viamed Valvanera, Spain

Other

Collaborators

  • Campus Bio-Medico University

Registry information

Official study title

Observational Study of Comparison of Echocardiographic Markers of Right Ventricular Function and Electrocardiographic Signs of Chronic Cor Pulmonale in Elderly Patient With COPD

Acronym: PVR-COPD

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2012
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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