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

NCT01554774 | Completed DMC

• 1 other identifier: HVVV-CBM-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension; Cor Pulmonale

Keywords

COPD; PVR

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Right ventricular function and FEV1.

  cross sectional

• ECG and echocardiography parameters of cor pulmonale

  cross sectional

• Right ventricle function and 6M-WT.

  cross sectional

Study Arms (3)

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 Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Viamed Valvanera, Spain: lead
• Campus Bio-Medico University: collaborator

Study Sites (1)

Campus Bio-Medico University

Roma, Italy, 00128, Italy

Location

Related Publications (12)

• 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. doi: 10.1161/01.cir.99.12.1600.

  PMID: 10096937 BACKGROUND

• Scapellato F, Temporelli PL, Eleuteri E, Corra 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. doi: 10.1016/s0735-1097(01)01271-2.

  PMID: 11401116 BACKGROUND

• 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. doi: 10.1016/s0735-1097(02)02973-x.

  PMID: 12651052 BACKGROUND

• Bossone E, Bodini BD, Mazza A, Allegra L. Pulmonary arterial hypertension: the key role of echocardiography. Chest. 2005 May;127(5):1836-43. doi: 10.1378/chest.127.5.1836.

  PMID: 15888866 BACKGROUND

• 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.

  PMID: 20206827 BACKGROUND

• 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.

  PMID: 19307098 BACKGROUND

• 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.

  PMID: 21439783 BACKGROUND

• 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.

  PMID: 18328836 BACKGROUND

• 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. doi: 10.1253/circj.71.1721.

  PMID: 17965491 BACKGROUND

• 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. doi: 10.1164/rccm.200210-1130OC. Epub 2002 Dec 12.

  PMID: 12480614 BACKGROUND

• Barbera JA, Peinado VI, Santos S. Pulmonary hypertension in chronic obstructive pulmonary disease. Eur Respir J. 2003 May;21(5):892-905. doi: 10.1183/09031936.03.00115402.

  PMID: 12765440 BACKGROUND

• 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. doi: 10.1161/01.cir.101.12.e117. No abstract available.

  PMID: 10736299 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Pulmonary Heart Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Vincenzo Malafarina, MD MSC

  Hospital Viamed Valvanera, Spain

  PRINCIPAL INVESTIGATOR

• Raffaele Antonelli Incalzi, MD

  Campus Bio-Medico University. S. Raffaele - Cittadella della Carità Foundation, Taranto, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 15, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

IT (1)