Hypertension, PulmonaryNCT01423071
Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension: Prevalence and Quality of Life
An observational study of Hypertension, Pulmonary and Pulmonary Disease, Chronic Obstructive, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
The purpose of this study is to determine the prevalence of pulmonary hypertension (PH) among patients suffering from Chronic Obstructive Pulmonary Disease (COPD) and to assess the quality of life in those patients with concomitant PH compared to COPD patients without PH and those only suffering from pulmonary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In- and out-patients at the investigational center
Who may be able to join
- Age ≥ 18 years
- Known or newly diagnosed COPD or PAH
- Written informed consent
- Present long-term oxygen treatment is no exclusion criterion
Who cannot join
- Age < 18 years
- Right-heart catheterization not reasonable
- Pregnancy, Lactation
- Life expectancy <12 months due to any diseases aside from COPD
- Any medical, psychological or other condition, which limits the patient's ability to provide informed consent
- No written informed consent provided
- Current participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep Medicine and Respiratory Care, Institute for Pneumology at the University Witten/Herdecke
Solingen, North Rhine-Westphalia, 42699
About this study
Official title: Chronisch Obstruktive Lungenerkrankung Und Pulmonale Hypertonie: Prävalenz Und Lebensqualität
The purpose of this study is to determine the prevalence of pulmonary hypertension (PH) among patients suffering from Chronic Obstructive Pulmonary Disease (COPD) and to assess the quality of life in those patients with concomitant PH compared to COPD patients without PH and those only suffering from pulmonary arterial hypertension (PAH) respectively.
- Keywords
- Pulmonary Hypertension, Chronic obstructive pulmonary disease, Prevalence, Quality of life
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| COPD with PH | COPD patients with confirmed diagnosis of PH. | |
| COPD without PH | COPD patients without confirmed diagnosis of PH | |
| PAH without COPD | PAH patients who do not suffer from COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of PH
Prevalence of PH as defined by ESC/ERS guidelines (mean pulmonary arterial pressure ≥25 mmHg, assessed by right-heart catheterization) among the subgroup of COPD GOLD III and IV patients.
Measured: At baseline
Secondary outcomes (1)
Quality of life
Explorative data analysis to assess correlation between quality of life and PH, by comparison of COPD patients with and without PH and a reference group of patients with only PAH.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion Pharmaceuticals Deutschland GmbH
- Responsible party
- Sponsor
- Investigators
- Winfried J Randerath, Prof. Dr. med., Principal investigator, Wissenschaftliches Institut Bethanien e.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423071
- Sponsor's protocol ID
- WI_PH+COPD_73/2011
- Status last verified
- Jun 2015
- First submitted
- 23 Aug 2011
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Warwick G, Thomas PS, Yates DH. Biomarkers in pulmonary hypertension. Eur Respir J. 2008 Aug;32(2):503-12. doi: 10.1183/09031936.00160307.
PubMed 18669790Kessler R, Faller M, Fourgaut G, Mennecier B, Weitzenblum E. Predictive factors of hospitalization for acute exacerbation in a series of 64 patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Jan;159(1):158-64. doi: 10.1164/ajrccm.159.1.9803117.
PubMed 9872834Oswald-Mammosser M, Weitzenblum E, Quoix E, Moser G, Chaouat A, Charpentier C, Kessler R. Prognostic factors in COPD patients receiving long-term oxygen therapy. Importance of pulmonary artery pressure. Chest. 1995 May;107(5):1193-8. doi: 10.1378/chest.107.5.1193.
PubMed 7750305Barbera 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 12765440Weitzenblum E. Chronic cor pulmonale. Heart. 2003 Feb;89(2):225-30. doi: 10.1136/heart.89.2.225. No abstract available.
PubMed 12527688Chaouat A, Bugnet AS, Kadaoui N, Schott R, Enache I, Ducolone A, Ehrhart M, Kessler R, Weitzenblum E. Severe pulmonary hypertension and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Jul 15;172(2):189-94. doi: 10.1164/rccm.200401-006OC. Epub 2005 Apr 14.
PubMed 15831842Arcasoy 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 12480614Burrows B, Kettel LJ, Niden AH, Rabinowitz M, Diener CF. Patterns of cardiovascular dysfunction in chronic obstructive lung disease. N Engl J Med. 1972 Apr 27;286(17):912-8. doi: 10.1056/NEJM197204272861703. No abstract available.
PubMed 5013974Weitzenblum E, Hirth C, Ducolone A, Mirhom R, Rasaholinjanahary J, Ehrhart M. Prognostic value of pulmonary artery pressure in chronic obstructive pulmonary disease. Thorax. 1981 Oct;36(10):752-8. doi: 10.1136/thx.36.10.752.
PubMed 7330793Vizza CD, Lynch JP, Ochoa LL, Richardson G, Trulock EP. Right and left ventricular dysfunction in patients with severe pulmonary disease. Chest. 1998 Mar;113(3):576-83. doi: 10.1378/chest.113.3.576.
PubMed 9515827Hoeper MM, Barbera JA, Channick RN, Hassoun PM, Lang IM, Manes A, Martinez FJ, Naeije R, Olschewski H, Pepke-Zaba J, Redfield MM, Robbins IM, Souza R, Torbicki A, McGoon M. Diagnosis, assessment, and treatment of non-pulmonary arterial hypertension pulmonary hypertension. J Am Coll Cardiol. 2009 Jun 30;54(1 Suppl):S85-S96. doi: 10.1016/j.jacc.2009.04.008.
PubMed 19555862Viegi G, Pistelli F, Sherrill DL, Maio S, Baldacci S, Carrozzi L. Definition, epidemiology and natural history of COPD. Eur Respir J. 2007 Nov;30(5):993-1013. doi: 10.1183/09031936.00082507.
PubMed 17978157Cenedese E, Speich R, Dorschner L, Ulrich S, Maggiorini M, Jenni R, Fischler M. Measurement of quality of life in pulmonary hypertension and its significance. Eur Respir J. 2006 Oct;28(4):808-15. doi: 10.1183/09031936.06.00130405. Epub 2006 May 17.
PubMed 16707511Hoeper MM, Oudiz RJ, Peacock A, Tapson VF, Haworth SG, Frost AE, Torbicki A. End points and clinical trial designs in pulmonary arterial hypertension: clinical and regulatory perspectives. J Am Coll Cardiol. 2004 Jun 16;43(12 Suppl S):48S-55S. doi: 10.1016/j.jacc.2004.02.010.
PubMed 15194178Rubenfire M, Lippo G, Bodini BD, Blasi F, Allegra L, Bossone E. Evaluating health-related quality of life, work ability, and disability in pulmonary arterial hypertension: an unmet need. Chest. 2009 Aug;136(2):597-603. doi: 10.1378/chest.08-1260.
PubMed 19666759
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronisch Obstruktive Lungenerkrankung Und Pulmonale Hypertonie: Prävalenz Und Lebensqualität
- ClinicalTrials.gov ID
- NCT01423071
- Acronym / sponsor ID
- WI_PH+COPD_73/2011
- Keywords
- Pulmonary Hypertension, Chronic obstructive pulmonary disease, Prevalence, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Collaborators
- Actelion Pharmaceuticals Deutschland GmbH
- Study start
- Aug 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 Aug 2011 (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.
The purpose of this study is to determine the prevalence of pulmonary hypertension (PH) among patients suffering from Chronic Obstructive Pulmonary Disease (COPD) and to assess the quality of life in those patients with concomitant PH compared to COPD patients without PH and those only suffering from pulmonary arterial hypertension (PAH) respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD with PH | – | –COPD patients with confirmed diagnosis of PH. |
| COPD without PH | – | –COPD patients without confirmed diagnosis of PH |
| PAH without COPD | – | –PAH patients who do not suffer from COPD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In- and out-patients at the investigational center
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Known or newly diagnosed COPD or PAH
- Written informed consent
- Present long-term oxygen treatment is no exclusion criterion
Key exclusion criteria (7 listed)
- Age < 18 years
- Right-heart catheterization not reasonable
- Pregnancy, Lactation
- Life expectancy <12 months due to any diseases aside from COPD
- Any medical, psychological or other condition, which limits the patient's ability to provide informed consent
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
Prevalence of PH
Time frame: At baseline
Prevalence of PH as defined by ESC/ERS guidelines (mean pulmonary arterial pressure ≥25 mmHg, assessed by right-heart catheterization) among the subgroup of COPD GOLD III and IV patients.
1 secondary outcome
Quality of life
Time frame: One year
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 18 Jun 2015.
- Background: PubMed 18669790Warwick G, Thomas PS, Yates DH. Biomarkers in pulmonary hypertension. Eur Respir J. 2008 Aug;32(2):503-12. doi: 10.1183/09031936.00160307.
- Background: PubMed 9872834Kessler R, Faller M, Fourgaut G, Mennecier B, Weitzenblum E. Predictive factors of hospitalization for acute exacerbation in a series of 64 patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Jan;159(1):158-64. doi: 10.1164/ajrccm.159.1.9803117.
- Background: PubMed 7750305Oswald-Mammosser M, Weitzenblum E, Quoix E, Moser G, Chaouat A, Charpentier C, Kessler R. Prognostic factors in COPD patients receiving long-term oxygen therapy. Importance of pulmonary artery pressure. Chest. 1995 May;107(5):1193-8. doi: 10.1378/chest.107.5.1193.
- 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 12527688Weitzenblum E. Chronic cor pulmonale. Heart. 2003 Feb;89(2):225-30. doi: 10.1136/heart.89.2.225. No abstract available.
- Background: PubMed 15831842Chaouat A, Bugnet AS, Kadaoui N, Schott R, Enache I, Ducolone A, Ehrhart M, Kessler R, Weitzenblum E. Severe pulmonary hypertension and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Jul 15;172(2):189-94. doi: 10.1164/rccm.200401-006OC. Epub 2005 Apr 14.
- 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 5013974Burrows B, Kettel LJ, Niden AH, Rabinowitz M, Diener CF. Patterns of cardiovascular dysfunction in chronic obstructive lung disease. N Engl J Med. 1972 Apr 27;286(17):912-8. doi: 10.1056/NEJM197204272861703. No abstract available.
- Background: PubMed 7330793Weitzenblum E, Hirth C, Ducolone A, Mirhom R, Rasaholinjanahary J, Ehrhart M. Prognostic value of pulmonary artery pressure in chronic obstructive pulmonary disease. Thorax. 1981 Oct;36(10):752-8. doi: 10.1136/thx.36.10.752.
- Background: PubMed 9515827Vizza CD, Lynch JP, Ochoa LL, Richardson G, Trulock EP. Right and left ventricular dysfunction in patients with severe pulmonary disease. Chest. 1998 Mar;113(3):576-83. doi: 10.1378/chest.113.3.576.
- Background: PubMed 19555862Hoeper MM, Barbera JA, Channick RN, Hassoun PM, Lang IM, Manes A, Martinez FJ, Naeije R, Olschewski H, Pepke-Zaba J, Redfield MM, Robbins IM, Souza R, Torbicki A, McGoon M. Diagnosis, assessment, and treatment of non-pulmonary arterial hypertension pulmonary hypertension. J Am Coll Cardiol. 2009 Jun 30;54(1 Suppl):S85-S96. doi: 10.1016/j.jacc.2009.04.008.
- Background: PubMed 17978157Viegi G, Pistelli F, Sherrill DL, Maio S, Baldacci S, Carrozzi L. Definition, epidemiology and natural history of COPD. Eur Respir J. 2007 Nov;30(5):993-1013. doi: 10.1183/09031936.00082507.
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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.
Winfried J Randerath, Prof. Dr. med. principal investigator
Wissenschaftliches Institut Bethanien e.V
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 Hypertension, Pulmonary and Pulmonary Disease, Chronic Obstructive, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
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 4 inclusion and 7 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 18 Jun 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 Germany. 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?
Prevalence of PH (time frame: At baseline). 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 NCT01423071, which also lists 18 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 18 Jun 2015; AzTrials last refreshed its copy on 7 Nov 2026.