Chronic Obstructive Pulmonary DiseasePVR-COPDNCT01554774
Non-invasive Assessment of Pulmonary Vascular Resistance in Elderly Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, run by Hospital Viamed Valvanera, Spain at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension, Cor Pulmonale
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive series of patients with a diagnosis of COPD who were treated in the consulting rooms of the department of respiratory physiopathology.
Who may be able to join
- diagnosis of COPD stage II, III or IV according to the GOLD guidelines
- signed the informed consent
Who cannot join
- ischemic cardiopathy
- severe valvular disease
- atrial fibrillation
- left bundle branch block
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Keywords
- COPD, PVR
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: cross sectional
Secondary outcomes (3)
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.
Measured: cross sectional
ECG and echocardiography parameters of cor pulmonale
The correlation between right ventricular function and the electrocardiographic parameters of cor pulmonale.
Measured: cross sectional
Right ventricle function and 6M-WT.
Evaluate the correlation between the hemodynamic indices of right ventricle and the six minute walking test (6M-WT).
Measured: cross sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Viamed Valvanera, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University
- Responsible party
- Principal investigator, Vincenzo Malafarina, MD MSc, Hospital Viamed Valvanera, Spain
- Investigators
- Vincenzo Malafarina, MD MSC, Principal investigator, Hospital Viamed Valvanera, SpainRaffaele Antonelli Incalzi, MD, Study director, Campus Bio-Medico University. S. Raffaele - Cittadella della Carità Foundation, Taranto, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554774
- Sponsor's protocol ID
- HVVV-CBM-01
- Acronym
- PVR-COPD
- Status last verified
- Feb 2015
- First submitted
- 2 Mar 2012
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10096937Scapellato 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.
PubMed 11401116Abbas 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.
PubMed 12651052Bossone 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.
PubMed 15888866Milan 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.
PubMed 20206827Haddad 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.
PubMed 19307098Kim 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.
PubMed 21439783Farzaneh-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.
PubMed 18328836Choi 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.
PubMed 17965491Arcasoy 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.
PubMed 12480614Barbera 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.
PubMed 12765440Burgess 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.
PubMed 10736299
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01554774
- Acronym / sponsor ID
- PVR-COPD / HVVV-CBM-01
- Keywords
- COPD, PVR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Viamed Valvanera, SpainUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive series of patients with a diagnosis of COPD who were treated in the consulting rooms of the department of respiratory physiopathology.
Key inclusion criteria (2 listed)
- diagnosis of COPD stage II, III or IV according to the GOLD guidelines
- signed the informed consent
Key exclusion criteria (4 listed)
- ischemic cardiopathy
- severe valvular disease
- atrial fibrillation
- left bundle branch block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Right ventricular function and FEV1.
Time frame: cross sectional
ECG and echocardiography parameters of cor pulmonale
Time frame: cross sectional
Right ventricle function and 6M-WT.
Time frame: cross sectional
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Background: PubMed 10096937Incalzi 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.
- Background: PubMed 11401116Scapellato 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.
- Background: PubMed 12651052Abbas 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.
- Background: PubMed 15888866Bossone 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.
- Background: PubMed 20206827Milan 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.
- Background: PubMed 19307098Haddad 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.
- Background: PubMed 21439783Kim 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.
- Background: PubMed 18328836Farzaneh-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.
- Background: PubMed 17965491Choi 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.
- Background: PubMed 12480614Arcasoy 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.
- Background: PubMed 12765440Barbera 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.
- Background: PubMed 10736299Burgess 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Malafarina, MD MSC principal investigator
Hospital Viamed Valvanera, Spain
Raffaele Antonelli Incalzi, MD study director
Campus Bio-Medico University. S. Raffaele - Cittadella della Carità Foundation, Taranto, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, run by Hospital Viamed Valvanera, Spain at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
right ventricular function and GOLD stages (time frame: cross sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01554774, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.