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AzTrials

Pulmonary Arterial Hypertension (PAH)COMPERANCT01347216

COMPERA / COMPERA-KIDS

An observational study of Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH), run by Technische Universität Dresden at 7 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In view of the manifold options for mono- and combination therapy that have now emerged for patients with pulmonary (arterial) hypertension (PH/PAH), controlled clinical trials can only provide part of the information needed for optimal management. Read more about this study

Who is it for?
Ages 1 week and older
How many people
14,000 participants
Where
7 sitesin 4 countries
Study dates
1 Jul 2007to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 1 week and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with any manifestation of pulmonary hypertension

Who may be able to join

  • All age groups (amendment dated 1 June 2013)
  • Written informed consent
  • Pulmonary hypertension (PH) of either
  • PAH: idiopathic form (IPAH) or
  • PAH associated with connective tissue diseases (PAH-CTD), with congenital heart defects (PAH-CHD), with HIV infection (PAH-HIV), or the portopulmonary form
  • Chronic thromboembolic PH (CTEPH)
Show all 12Show fewer
  • PH in left heart diseases (with isolated diastolic dysfunction; with systolic dysfunction, other)
  • PH in pulmonary disease (chronic obstructive pulmonary disease; interstitial fibrosis, etc.)
  • "Relative PH" in CHD after cavopulmonary anastomosis or Fontan-type surgery, even without the classical pulmonary pressure criteria of PH.
  • Newly initiated (i.e. a maximum of 3 months before documentation for the first time) therapy with endothelin receptor antagonists (ERA), phoshodiesterase-5 (PDE-5) inhibitors, soluble guanylate cyclase (sGC) stimulators or prostacyclins in mono- or combination therapy.
  • Exceptions: PAH-CHD patients can be included on maintenance or newly initiated PAH therapy (3-month rule dose not apply).
  • PAH-CHD patients with severe pulmonary vascular disease (e.g. Eisenmenger physiology) irrespective of treatment with any PAH drugs are eligible for inclusion, too.

Who cannot join

  • Patients on maintenance therapy, i.e. previous treatment with any ERA/ PDE-5 inhibitor/prostacyclin/sGC stimulator drug longer than 3 months before documentation for the first time (exception: PAH-CHD patients).

Trial locations and contacts

7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

David Pittrow, MD, PhD contact

+498152 ext. 9989803

david.pittrow@mailbox.tu-dresden.de

Marius M. Hoeper, MD, PhD contact

+49511532 ext. 3537

Hoeper.Marius@mh-hannover.de

7 sites in 4 countries

Germany4 sites, 4 recruiting

  • DRK-Klinikum Köpenick

    Berlin

    Christian Opitz, MD, PhD

    Christian Opitz, MD, PhD

    Recruiting

  • Lung Centre, University of Giessen

    Giessen

    Ardeschir Ghofrani, MD, PhD

    Ardeschir Ghofrani, MD

    Recruiting

  • Department of Pulmology; Hannover Medical School

    Hanover

    Marius M Hoeper

    Marius M Hoeper, MD, PhD

    Recruiting

  • German Heart Centre

    Munich

    Harald Kaemmerer, MD,. PhD

    Harald Kaemmerer, MD, PhD

    Recruiting

Other trials in Germany

Belgium1 site, 1 recruiting

  • Dept. of Pneumology, University

    Leuven

    Marion Delcroix, MD, PhD

    Marion Delcroix, MD, PhD

    Recruiting

Other trials in Belgium

Italy1 site, 1 recruiting

  • Department of Cardiovascular and Respiratory Sciences, University La Sapienza

    Rome

    Dario Vizza, MD, PhD

    Dario Vizza, MD, PhD

    Recruiting

Other trials in Italy

Switzerland1 site, 1 recruiting

  • Dept. for Rheumatology, University Hospital

    Zurich

    Oliver Distler, MD, PhD

    Oliver Distler, MD, PhD

    Recruiting

Other trials in Switzerland

About this study

Official title: Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension

In view of the manifold options for mono- and combination therapy that have now emerged for patients with pulmonary (arterial) hypertension (PH/PAH), controlled clinical trials can only provide part of the information needed for optimal management. In order to gather adequate data on PAH/PH treatment in routine clinical care, the ongoing COMPERA registry prospectively documents consecutive patients with newly initiated treatment of PAH/PAH since May 2007. The internet-based registry fulfills high quality standards through several measures (planned minimum centre contribution of at least 10 patients per year, automated plausibility checks of data at entry, queries, monitoring with source data verification in >50% of participating centers). It can be applied, among further purposes, for quality assurance: individual centers can confidentially compare their results with the combined outcome of other centers and the recommendations from guidelines. It is expected that the register contributes to optimization of specific drug therapy for PAH and PH.

Since July 2013, also children of any age can be documented (COMPERA-KIDS).

Read the detailed description

COMPERA will report current and comprehensive data on

  • Demographics and clinical course of incident and prevalent PAH and PH patients
  • Patient outcomes including survival, by subgroup, by treatment strategy and other factors
  • Clinical predictors of short-term and long-term clinical outcomes
  • Relationship between PAH medications and patient outcomes
  • Temporal trends in treatments and outcomes for newly diagnosed patients
  • The state of implementation of current PAH guidelines
  • Evolving research needs of the PAH community
  • Patients with PAH associated with congenital heart disease and Eisenmenger physiology who do not receive specific drug therapy for PAH ("COMPERA-Eisenmenger", as stated in the amendment dated 23. January 2012).
  • Children of any age with PH or PAH (all Dana Point groups), as stated in the amendment dated 1 June 2013 ("COMPERA-KIDS").
Keywords
Drug treatment, Treatment pathways, Clinical routine, Registry, Treatment outcomes, Endothelin receptor antagonist, Phosphodiesterase-V inhibitor, Prostanoid, Sildenafil, Bosentan, Macitentan, Sitaxentan, Ambrisentan, Imatinib, Epoprostenol, Treprostinil, Iloprost, Infusion pump, Riociguat, soluble guanylate cyclase stimulator
Medical subject headings
Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Eisenmenger Complex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients on monotherapy vs combination therapies at baseline and during follow-up (drug utilisation patterns)

    Measured: Up to 10 years after inclusion

Secondary outcomes (2)

  1. Number of patients in the various Dana Point groups (patient characteristics in PAH and non-PAH pulmonary hypertension groups)

    Measured: Up to 10 years after inclusion

  2. Probability of survival in the various Dana Point groups (PAH and non-PAH pulmonary hypertension groups) by Kaplan-Meier estimate

    Measured: Up to 10 years after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2011 (estimated)
  2. Study start1 Jul 2007
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
14,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01347216
Sponsor's protocol ID
COMPERA
Acronym
COMPERA
Status last verified
Jan 2025
First submitted
3 May 2011
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data sharing has not been planned.

Publications

  • Pittrow D, Ghofrani HA, Opitz CF, Huscher D, Hoeper MM. [International, prospective register for the documentation of first-line and maintenance therapy in patients with pulmonary hypertension (CompERA-XL)]. Dtsch Med Wochenschr. 2009 Aug;134 Suppl 5:S173-5. doi: 10.1055/s-0029-1225318. Epub 2009 Aug 28. German.

    PubMed 19718609

  • Pausch C, Pittrow D, Hoeper MM, Huscher D. Performance of the ESC/ERS 4-strata risk stratification model for pulmonary arterial hypertension with missing variables. Eur Respir J. 2023 Nov 29;62(5):2301023. doi: 10.1183/13993003.01023-2023. Print 2023 Nov.

    PubMed 37802633

  • Hoeper MM, Huscher D, Ghofrani HA, Delcroix M, Distler O, Schweiger C, Grunig E, Staehler G, Rosenkranz S, Halank M, Held M, Grohe C, Lange TJ, Behr J, Klose H, Wilkens H, Filusch A, Germann M, Ewert R, Seyfarth HJ, Olsson KM, Opitz CF, Gaine SP, Vizza CD, Vonk-Noordegraaf A, Kaemmerer H, Gibbs JS, Pittrow D. Elderly patients diagnosed with idiopathic pulmonary arterial hypertension: results from the COMPERA registry. Int J Cardiol. 2013 Sep 30;168(2):871-80. doi: 10.1016/j.ijcard.2012.10.026. Epub 2012 Nov 17.

    PubMed 23164592

  • Olsson KM, Delcroix M, Ghofrani HA, Tiede H, Huscher D, Speich R, Grunig E, Staehler G, Rosenkranz S, Halank M, Held M, Lange TJ, Behr J, Klose H, Claussen M, Ewert R, Opitz CF, Vizza CD, Scelsi L, Vonk-Noordegraaf A, Kaemmerer H, Gibbs JS, Coghlan G, Pepke-Zaba J, Schulz U, Gorenflo M, Pittrow D, Hoeper MM. Anticoagulation and survival in pulmonary arterial hypertension: results from the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA). Circulation. 2014 Jan 7;129(1):57-65. doi: 10.1161/CIRCULATIONAHA.113.004526. Epub 2013 Sep 30.

    PubMed 24081973

  • Kramm T, Wilkens H, Fuge J, Schafers HJ, Guth S, Wiedenroth CB, Weingard B, Huscher D, Pittrow D, Cebotari S, Hoeper MM, Mayer E, Olsson KM. Incidence and characteristics of chronic thromboembolic pulmonary hypertension in Germany. Clin Res Cardiol. 2018 Jul;107(7):548-553. doi: 10.1007/s00392-018-1215-5. Epub 2018 Feb 15.

    PubMed 29450722

  • Hoeper MM, Kramer T, Pan Z, Eichstaedt CA, Spiesshoefer J, Benjamin N, Olsson KM, Meyer K, Vizza CD, Vonk-Noordegraaf A, Distler O, Opitz C, Gibbs JSR, Delcroix M, Ghofrani HA, Huscher D, Pittrow D, Rosenkranz S, Grunig E. Mortality in pulmonary arterial hypertension: prediction by the 2015 European pulmonary hypertension guidelines risk stratification model. Eur Respir J. 2017 Aug 3;50(2):1700740. doi: 10.1183/13993003.00740-2017. Print 2017 Aug.

    PubMed 28775047

  • Hoeper MM, Pittrow D, Opitz C, Gibbs JSR, Rosenkranz S, Grunig E, Olsson KM, Huscher D. Risk assessment in pulmonary arterial hypertension. Eur Respir J. 2018 Mar 29;51(3):1702606. doi: 10.1183/13993003.02606-2017. Print 2018 Mar. No abstract available.

    PubMed 29599117

  • Zelniker TA, Huscher D, Vonk-Noordegraaf A, Ewert R, Lange TJ, Klose H, Dumitrescu D, Halank M, Held M, Gall H, Pittrow D, Hoeper MM, Frankenstein L. The 6MWT as a prognostic tool in pulmonary arterial hypertension: results from the COMPERA registry. Clin Res Cardiol. 2018 Jun;107(6):460-470. doi: 10.1007/s00392-018-1207-5. Epub 2018 Jan 24.

    PubMed 29368137

  • Delcroix M, Staehler G, Gall H, Grunig E, Held M, Halank M, Klose H, Vonk-Noordegraaf A, Rosenkranz S, Pepke-Zaba J, Opitz CF, Gibbs JSR, Lange TJ, Tsangaris I, Huscher D, Pittrow D, Olsson KM, Hoeper MM. Risk assessment in medically treated chronic thromboembolic pulmonary hypertension patients. Eur Respir J. 2018 Nov 8;52(5):1800248. doi: 10.1183/13993003.00248-2018. Print 2018 Nov.

    PubMed 30337446

  • Kaemmerer H, Gorenflo M, Huscher D, Pittrow D, Apitz C, Baumgartner H, Berger F, Bruch L, Brunnemer E, Budts W, Claussen M, Coghlan G, Dahnert I, D'Alto M, Delcroix M, Distler O, Dittrich S, Dumitrescu D, Ewert R, Faehling M, Germund I, Ghofrani HA, Grohe C, Grossekreymborg K, Halank M, Hansmann G, Harzheim D, Nemes A, Havasi K, Held M, Hoeper MM, Hofbeck M, Hohenfrost-Schmidt W, Jureviciene E, Gumbiene L, Kabitz HJ, Klose H, Kohler T, Konstantinides S, Koestenberger M, Kozlik-Feldmann R, Kramer HH, Kropf-Sanchen C, Lammers A, Lange T, Meyn P, Miera O, Milger-Kneidinger K, Neidenbach R, Neurohr C, Opitz C, Perings C, Remppis BA, Riemekasten G, Scelsi L, Scholtz W, Simkova I, Skowasch D, Skride A, Stahler G, Stiller B, Tsangaris I, Vizza CD, Vonk Noordegraaf A, Wilkens H, Wirtz H, Diller GP, Grunig E, Rosenkranz S. Pulmonary Hypertension in Adults with Congenital Heart Disease: Real-World Data from the International COMPERA-CHD Registry. J Clin Med. 2020 May 13;9(5):1456. doi: 10.3390/jcm9051456.

    PubMed 32414075

  • Vizza CD, Hoeper MM, Huscher D, Pittrow D, Benjamin N, Olsson KM, Ghofrani HA, Held M, Klose H, Lange T, Rosenkranz S, Dumitrescu D, Badagliacca R, Claussen M, Halank M, Vonk-Noordegraaf A, Skowasch D, Ewert R, Gibbs JSR, Delcroix M, Skride A, Coghlan G, Ulrich S, Opitz C, Kaemmerer H, Distler O, Grunig E. Pulmonary Hypertension in Patients With COPD: Results From the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA). Chest. 2021 Aug;160(2):678-689. doi: 10.1016/j.chest.2021.02.012. Epub 2021 Feb 11.

    PubMed 33581097

  • Rosenkranz S, Pausch C, Coghlan JG, Huscher D, Pittrow D, Grunig E, Staehler G, Vizza CD, Gall H, Distler O, Delcroix M, Ghofrani HA, Ewert R, Kabitz HJ, Skowasch D, Behr J, Milger K, Halank M, Wilkens H, Seyfarth HJ, Held M, Scelsi L, Neurohr C, Vonk-Noordegraaf A, Ulrich S, Klose H, Claussen M, Eisenmann S, Schmidt KH, Remppis BA, Skride A, Jureviciene E, Gumbiene L, Miliauskas S, Loffler-Ragg J, Lange TJ, Olsson KM, Hoeper MM, Opitz C. Risk stratification and response to therapy in patients with pulmonary arterial hypertension and comorbidities: A COMPERA analysis. J Heart Lung Transplant. 2023 Jan;42(1):102-114. doi: 10.1016/j.healun.2022.10.003. Epub 2022 Oct 13.

    PubMed 36333206

  • Hoeper MM, Dwivedi K, Pausch C, Lewis RA, Olsson KM, Huscher D, Pittrow D, Grunig E, Staehler G, Vizza CD, Gall H, Distler O, Opitz C, Gibbs JSR, Delcroix M, Park DH, Ghofrani HA, Ewert R, Kaemmerer H, Kabitz HJ, Skowasch D, Behr J, Milger K, Lange TJ, Wilkens H, Seyfarth HJ, Held M, Dumitrescu D, Tsangaris I, Vonk-Noordegraaf A, Ulrich S, Klose H, Claussen M, Eisenmann S, Schmidt KH, Swift AJ, Thompson AAR, Elliot CA, Rosenkranz S, Condliffe R, Kiely DG, Halank M. Phenotyping of idiopathic pulmonary arterial hypertension: a registry analysis. Lancet Respir Med. 2022 Oct;10(10):937-948. doi: 10.1016/S2213-2600(22)00097-2. Epub 2022 Jun 28.

    PubMed 35777416

  • Hoeper MM, Pausch C, Olsson KM, Huscher D, Pittrow D, Grunig E, Staehler G, Vizza CD, Gall H, Distler O, Opitz C, Gibbs JSR, Delcroix M, Ghofrani HA, Park DH, Ewert R, Kaemmerer H, Kabitz HJ, Skowasch D, Behr J, Milger K, Halank M, Wilkens H, Seyfarth HJ, Held M, Dumitrescu D, Tsangaris I, Vonk-Noordegraaf A, Ulrich S, Klose H, Claussen M, Lange TJ, Rosenkranz S. COMPERA 2.0: a refined four-stratum risk assessment model for pulmonary arterial hypertension. Eur Respir J. 2022 Jul 7;60(1):2102311. doi: 10.1183/13993003.02311-2021. Print 2022 Jul.

    PubMed 34737226

  • Distler O, Ofner C, Huscher D, Jordan S, Ulrich S, Stahler G, Grunig E, Held M, Ghofrani HA, Claussen M, Lange TJ, Klose H, Rosenkranz S, Vonk-Noordegraaf A, Vizza CD, Delcroix M, Opitz C, Pausch C, Scelsi L, Neurohr C, Olsson KM, Coghlan JG, Halank M, Skowasch D, Behr J, Milger K, Remppis BA, Skride A, Jureviciene E, Gumbiene L, Miliauskas S, Loffler-Ragg J, Wilkens H, Pittrow D, Hoeper MM, Ewert R. Treatment strategies and survival of patients with connective tissue disease and pulmonary arterial hypertension: a COMPERA analysis. Rheumatology (Oxford). 2024 Apr 2;63(4):1139-1146. doi: 10.1093/rheumatology/kead360.

    PubMed 37462520

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH), run by Technische Universität Dresden at 7 sites in 4 countries.

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 12 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, Belgium, Italy, Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Pittrow, MD, PhD (+498152 ext. 9989803, david.pittrow@mailbox.tu-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients on monotherapy vs combination therapies at baseline and during follow-up (drug utilisation patterns) (time frame: Up to 10 years after inclusion). 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 NCT01347216, which also lists 19 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 24 Aug 2025.

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