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

NCT ID: NCT01554774

Last Updated: 2015-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Pulmonary Hypertension Cor Pulmonale

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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GOLD II

Will be included in this group the patients with COPD stage II

No interventions assigned to this group

GOLD III

Will be included in this group the patients with COPD stage III

No interventions assigned to this group

GOLD IV

Will be included in this group the patients with COPD stage VI.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role collaborator

Hospital Viamed Valvanera, Spain

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo Malafarina, MD MSc

MD MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincenzo Malafarina, MD MSC

Role: PRINCIPAL_INVESTIGATOR

Hospital Viamed Valvanera, Spain

Raffaele Antonelli Incalzi, MD

Role: STUDY_DIRECTOR

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

Locations

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Campus Bio-Medico University

Roma, Italy, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 10096937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11401116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12651052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15888866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20206827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19307098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21439783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18328836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17965491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12480614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12765440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10736299 (View on PubMed)

Other Identifiers

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HVVV-CBM-01

Identifier Type: -

Identifier Source: org_study_id

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