NCT01423071

Brief 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 arterial hypertension (PAH) respectively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

3.4 years

First QC Date

August 23, 2011

Last Update Submit

June 17, 2015

Conditions

Hypertension, PulmonaryPulmonary Disease, Chronic Obstructive

Keywords

Pulmonary HypertensionChronic obstructive pulmonary diseasePrevalenceQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline

Secondary Outcomes (1)

  • Quality of life

    One year

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In- and out-patients at the investigational center

You may qualify if:

  • Age ≥ 18 years
  • Known or newly diagnosed COPD or PAH
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, Germany

Location

Related Publications (18)

  • Warwick G, Thomas PS, Yates DH. Biomarkers in pulmonary hypertension. Eur Respir J. 2008 Aug;32(2):503-12. doi: 10.1183/09031936.00160307.

    PMID: 18669790BACKGROUND

  • Kessler 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.

    PMID: 9872834BACKGROUND

  • Oswald-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.

    PMID: 7750305BACKGROUND

  • 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: 12765440BACKGROUND

  • Weitzenblum E. Chronic cor pulmonale. Heart. 2003 Feb;89(2):225-30. doi: 10.1136/heart.89.2.225. No abstract available.

    PMID: 12527688BACKGROUND

  • Chaouat 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.

    PMID: 15831842BACKGROUND

  • 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: 12480614BACKGROUND

  • Burrows 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.

    PMID: 5013974BACKGROUND

  • Weitzenblum 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.

    PMID: 7330793BACKGROUND

  • Vizza 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.

    PMID: 9515827BACKGROUND

  • Hoeper 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.

    PMID: 19555862BACKGROUND

  • Viegi 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.

    PMID: 17978157BACKGROUND

  • Cenedese 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.

    PMID: 16707511BACKGROUND

  • Hoeper 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.

    PMID: 15194178BACKGROUND

  • Rubenfire 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.

    PMID: 19666759BACKGROUND

  • McKenna SP, Doughty N, Meads DM, Doward LC, Pepke-Zaba J. The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR): a measure of health-related quality of life and quality of life for patients with pulmonary hypertension. Qual Life Res. 2006 Feb;15(1):103-15. doi: 10.1007/s11136-005-3513-4.

    PMID: 16411035BACKGROUND

  • McKenna SP, Ratcliffe J, Meads DM, Brazier JE. Development and validation of a preference based measure derived from the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) for use in cost utility analyses. Health Qual Life Outcomes. 2008 Aug 21;6:65. doi: 10.1186/1477-7525-6-65.

    PMID: 18718016BACKGROUND

  • Meads DM, McKenna SP, Doughty N, Das C, Gin-Sing W, Langley J, Pepke-Zaba J. The responsiveness and validity of the CAMPHOR Utility Index. Eur Respir J. 2008 Dec;32(6):1513-9. doi: 10.1183/09031936.00069708. Epub 2008 Sep 3.

    PMID: 18768576BACKGROUND

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Winfried J Randerath, Prof. Dr. med.

    Wissenschaftliches Institut Bethanien e.V

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 25, 2011

Study Start

August 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 18, 2015

Record last verified: 2015-06

Locations

DE(1)