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

Chronic Obstructive Pulmonary Disease Clinical Trial

— PVR-COPD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554774
• Other study ID #: HVVV-CBM-01
• Status: Completed
• Phase: N/A
• First received: March 2, 2012
• Last updated: February 6, 2015
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: February 2015
• Source: Hospital Viamed Valvanera, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Cor Pulmonale
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Heart Disease
• Pulmonary Hypertension

Locations

Country	Name	City	State
Italy	Campus Bio-Medico University	Roma

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Viamed Valvanera, Spain	Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (12)

Abbas AE, Fortuin FD, Schiller NB, Appleton CP, Moreno CA, Lester SJ. A simple method for noninvasive estimation of pulmonary vascular resistance. J Am Coll Cardiol. 2003 Mar 19;41(6):1021-7. — View Citation

Arcasoy SM, Christie JD, Ferrari VA, Sutton MS, Zisman DA, Blumenthal NP, Pochettino A, Kotloff RM. Echocardiographic assessment of pulmonary hypertension in patients with advanced lung disease. Am J Respir Crit Care Med. 2003 Mar 1;167(5):735-40. Epub 2002 Dec 12. — View Citation

Barberà JA, Peinado VI, Santos S. Pulmonary hypertension in chronic obstructive pulmonary disease. Eur Respir J. 2003 May;21(5):892-905. Review. — View Citation

Bossone E, Bodini BD, Mazza A, Allegra L. Pulmonary arterial hypertension: the key role of echocardiography. Chest. 2005 May;127(5):1836-43. Review. — View Citation

Burgess MI, Ray S, Mogulkoc N, Egan J, Incalzi RA, Fuso L, Marino De Rosa, Di Napoli A, Basso S, Pagliari G, Pistelli R. Doppler echocardiographic index of global right ventricular function. Circulation. 2000 Mar 28;101(12):E117. — View Citation

Choi EY, Shim J, Kim SA, Shim CY, Yoon SJ, Kang SM, Choi D, Ha JW, Rim SJ, Jang Y, Chung N. Value of echo-Doppler derived pulmonary vascular resistance, net-atrioventricular compliance and tricuspid annular velocity in determining exercise capacity in patients with mitral stenosis. Circ J. 2007 Nov;71(11):1721-7. — View Citation

Farzaneh-Far R, Na B, Whooley MA, Schiller NB. Usefulness of noninvasive estimate of pulmonary vascular resistance to predict mortality, heart failure, and adverse cardiovascular events in Patients With stable coronary artery disease (from the Heart and Soul Study). Am J Cardiol. 2008 Mar 15;101(6):762-6. doi: 10.1016/j.amjcard.2007.11.010. Epub 2008 Feb 21. — View Citation

Haddad F, Zamanian R, Beraud AS, Schnittger I, Feinstein J, Peterson T, Yang P, Doyle R, Rosenthal D. A novel non-invasive method of estimating pulmonary vascular resistance in patients with pulmonary arterial hypertension. J Am Soc Echocardiogr. 2009 May;22(5):523-9. doi: 10.1016/j.echo.2009.01.021. Erratum in: J Am Soc Echocardiogr. 2010 Apr;23(4):376. — View Citation

Incalzi RA, Fuso L, De Rosa M, Di Napoli A, Basso S, Pagliari G, Pistelli R. Electrocardiographic signs of chronic cor pulmonale: A negative prognostic finding in chronic obstructive pulmonary disease. Circulation. 1999 Mar 30;99(12):1600-5. — View Citation

Kim SH, Yi MZ, Kim DH, Song JM, Kang DH, Lee SD, Song JK. Prognostic value of echocardiographic estimation of pulmonary vascular resistance in patients with acute pulmonary thromboembolism. J Am Soc Echocardiogr. 2011 Jun;24(6):693-8. doi: 10.1016/j.echo.2011.02.002. Epub 2011 Mar 24. — View Citation

Milan A, Magnino C, Veglio F. Echocardiographic indexes for the non-invasive evaluation of pulmonary hemodynamics. J Am Soc Echocardiogr. 2010 Mar;23(3):225-39; quiz 332-4. doi: 10.1016/j.echo.2010.01.003. Review. — View Citation

Scapellato F, Temporelli PL, Eleuteri E, Corrà U, Imparato A, Giannuzzi P. Accurate noninvasive estimation of pulmonary vascular resistance by Doppler echocardiography in patients with chronic failure heart failure. J Am Coll Cardiol. 2001 Jun 1;37(7):1813-9. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	right ventricular function and GOLD stages	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.	cross sectional	No
Secondary	Right ventricular function and FEV1.	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.	cross sectional	No
Secondary	ECG and echocardiography parameters of cor pulmonale	The correlation between right ventricular function and the electrocardiographic parameters of cor pulmonale.	cross sectional	No
Secondary	Right ventricle function and 6M-WT.	Evaluate the correlation between the hemodynamic indices of right ventricle and the six minute walking test (6M-WT).	cross sectional	No