COMPERA / COMPERA-KIDS

Pulmonary Arterial Hypertension (PAH) Clinical Trial

— COMPERA  

Official title:

Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01347216
• Other study ID #: COMPERA
• Status: Recruiting
• Start date: July 1, 2007
• Est. completion date: June 1, 2026

Study information

• Verified date: February 2024
• Source: Technische Universität Dresden
• Contact: David Pittrow, MD, PhD
• Phone: +498152
• Email: david.pittrow[@]mailbox.tu-dresden.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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").

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13000
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Week and older

Eligibility

Inclusion Criteria:

• 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)

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Arterial Hypertension (PAH)
• Pulmonary Hypertension (PH)

Locations

Country	Name	City	State
Belgium	Dept. of Pneumology, University	Leuven
Germany	DRK-Klinikum Köpenick	Berlin
Germany	Lung Centre, University of Giessen	Giessen
Germany	Department of Pulmology; Hannover Medical School	Hannover
Germany	German Heart Centre	Munich
Italy	Department of Cardiovascular and Respiratory Sciences, University La Sapienza	Rome
Switzerland	Dept. for Rheumatology, University Hospital	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	GWT-TUD GmbH

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Switzerland, 

References & Publications (25)

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 throm — View Citation

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, Sk — View Citation

Hoeper MM, Behr J, Held M, Grunig E, Vizza CD, Vonk-Noordegraaf A, Lange TJ, Claussen M, Grohe C, Klose H, Olsson KM, Zelniker T, Neurohr C, Distler O, Wirtz H, Opitz C, Huscher D, Pittrow D, Gibbs JS. Pulmonary Hypertension in Patients with Chronic Fibro — View Citation

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, Wi — View Citation

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 — View Citation

Hoeper MM, Huscher D, Pittrow D. Incidence and prevalence of pulmonary arterial hypertension in Germany. Int J Cardiol. 2016 Jan 15;203:612-3. doi: 10.1016/j.ijcard.2015.11.001. Epub 2015 Nov 9. No abstract available. — View Citation

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 — View Citation

Hoeper MM, Pausch C, Grunig E, Klose H, Staehler G, Huscher D, Pittrow D, Olsson KM, Vizza CD, Gall H, Benjamin N, Distler O, Opitz C, Gibbs JSR, Delcroix M, Ghofrani HA, Rosenkranz S, Ewert R, Kaemmerer H, Lange TJ, Kabitz HJ, Skowasch D, Skride A, Jurev — View Citation

Hoeper MM, Pausch C, Grunig E, Staehler G, Huscher D, Pittrow D, Olsson KM, Vizza CD, Gall H, Distler O, Opitz C, Gibbs JSR, Delcroix M, Ghofrani HA, Rosenkranz S, Park DH, Ewert R, Kaemmerer H, Lange TJ, Kabitz HJ, Skowasch D, Skride A, Claussen M, Behr — View Citation

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, Ewert R, Kaemmerer H, Kabitz HJ, Skowasch D, Behr J, Milger K, Halank M, Wilkens H, Seyfarth HJ, Held M, — View Citation

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, — View Citation

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. — View Citation

Kaemmerer AS, Gorenflo M, Huscher D, Pittrow D, Ewert P, Pausch C, Delcroix M, Ghofrani HA, Hoeper MM, Kozlik-Feldmann R, Skride A, Stahler G, Vizza CD, Jureviciene E, Jancauskaite D, Gumbiene L, Ewert R, Dahnert I, Held M, Halank M, Skowasch D, Klose H, — View Citation

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 — View Citation

Kanwar MK, Gomberg-Maitland M, Hoeper M, Pausch C, Pittrow D, Strange G, Anderson JJ, Zhao C, Scott JV, Druzdzel MJ, Kraisangka J, Lohmueller L, Antaki J, Benza RL. Risk stratification in pulmonary arterial hypertension using Bayesian analysis. Eur Respir — View Citation

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 — View Citation

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, Pep — View Citation

Olsson KM, Hoeper MM, Pausch C, Grunig E, Huscher D, Pittrow D, Rosenkranz S, Gall H. Pulmonary vascular resistance predicts mortality in patients with pulmonary hypertension associated with interstitial lung disease: results from the COMPERA registry. Eu — View Citation

Opitz CF, Hoeper MM, Gibbs JS, Kaemmerer H, Pepke-Zaba J, Coghlan JG, Scelsi L, D'Alto M, Olsson KM, Ulrich S, Scholtz W, Schulz U, Grunig E, Vizza CD, Staehler G, Bruch L, Huscher D, Pittrow D, Rosenkranz S. Pre-Capillary, Combined, and Post-Capillary Pu — View Citation

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. — View Citation

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. — View Citation

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-Noo — View Citation

Schmidt KH, Milger K, Pausch C, Huscher D, Pittrow D, Grunig E, Staehler G, Gall H, Distler O, Skowasch D, Halank M, Wilkens H, Held M, Klose H, Hoeper MM. Trends in COVID-19-associated mortality in patients with pulmonary hypertension: a COMPERA analysis — View Citation

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, — View Citation

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 — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients on monotherapy vs combination therapies at baseline and during follow-up (drug utilisation patterns)		Up to 10 years after inclusion
Secondary	Number of patients in the various Dana Point groups (patient characteristics in PAH and non-PAH pulmonary hypertension groups)		Up to 10 years after inclusion
Secondary	Probability of survival in the various Dana Point groups (PAH and non-PAH pulmonary hypertension groups) by Kaplan-Meier estimate		Up to 10 years after inclusion

External Links

•   COMPERA website