I27.0
Conditions
Interventions
Group 1: PAH-patients who have been well-adjusted to their PAH-medication for at least one month will have their serum levels of their PAH medication checked and fill out the A-14 SES6G, Gad-7, PHQ-9
Sponsors
Zentrum für Pulmonale Hypertonie Thoraxklinik Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients = 18 years Consent to the Heidelberg Broad Consent Lung Biobank (V. 1.9) and the Biobank of the Center for Pulmonary Hypertension (V. 1) Hemodynamic confirmation (via right heart catheterization) of PH from the following WHO groups: WHO Group I including the following subgroups: • Idiopathic PAH (IPAH) • Hereditary PAH (HPAH) • Associated PAH (APAH): Drug-associated or toxin-associated PAH, PAH associated with connective tissue disorders, PAH associated with HIV infection, PAH associated with portal hypertension, PAH associated with congenital heart defects, PAH associated with schistosomiasis, PAH with a good long-term response to calcium channel blockers, PAH with evidence of pulmonary veno-occlusive disease, PAH with Indication of pulmonary capillary hemangiomatosis, persistent PAH of the newborn o Stable treatment with oral PAH-specific medications (endothelin receptor antagonists, phosphodiesterase-5 inhibitors and soluble guanylate cyclase stimulators) for at least one month.
Exclusion criteria
Exclusion criteria: o Minor patients o Lack of hemodynamic evidence of PH / No guideline-compliant diagnosis via right heart catheterization o Patients with confirmed PH of WHO groups II, III, IV, and V and patients of WHO group I with subgroups other than those listed under the inclusion criteria o Pregnancy/Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of plasma levels of PAH medication outside the therapeutic window Subjectively assessed adherence | — |
Secondary
| Measure | Time frame |
|---|---|
| Adherence assessed using the A-14 questionnaire, SES6G, Gad-7, PHQ-9, EQ5D, SIMS-D and MARS-D, and parameters influencing adherence: age, gender, efficacy of therapy, duration of therapy, time since diagnosis, severity of disease, last medication intake, number of PAH medications, drug class and route of administration of PAH medication, number of comedications, comorbidities, smoking status, number of inpatient/outpatient hospital stays during the observation period due to PH, Medication possession ratio (ratio of the number of days the medication is available for the person to the number of days the medication should be available), setting of drug therapy initiation (inpatient vs. outpatient), social support, family environment, level of education, employment status and side effects | — |
Countries
Germany
Contacts
Public ContactEkkehard Grünig
Zentrum Pulmonale Hypertonie Thoraxklinik Heidelberg
Outcome results
None listed