Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06445673

A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients

The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study.

The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial.

Planned observation duration per patient is a minimum of 3 years.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ordensklinikum Linz, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients previously participating in the randomized TripleTRE trial who are able and willing to provide a signed informed consent for study participation in NIS

Exclusion criteria

  • Lost to follow-up patients of TripleTRE study
  • Patients who discontinued all medicinal PAH treatments (e.g. after successful lung transplantation)
  • Patients who withdrew from the initial TripleTRE trial due to significant non-compliance with trial requirements (not adhering to therapy, not coming to hospital visits)

Treatment and study plan

Primary outcomes

  1. Time to death or lung transplantation

    Time frame: up to year 3

  2. Time to first clinical worsening

    Time frame: up to year 3

    clinical worsening is defined as fulfilling on of the following criteria:

    • PAH related death (including all deaths where PAH cannot be excluded as cause)
    • Lung transplantation due to PAH
    • PAH-related hospitalization
    • Post baseline decrease in 6MWD by 15%
    • Post baseline worsening of WHO FC

  3. Total number of clinical worsenings

    Time frame: up to year 3

    clinical worsening is defined as fulfilling on of the following criteria:

    • PAH related death (including all deaths where PAH cannot be excluded as cause)
    • Lung transplantation due to PAH
    • PH-related hospitalization
    • Post baseline decrease in 6MWD by 15%
    • Post baseline worsening of WHO FC

Secondary outcomes

  1. Long-term change in 6MWD

    Time frame: up to year 3

    6-Minute Walking Distance (6MWD) will be measured in meters

  2. Long-term change in PAH treatment regimens

    Time frame: up to year 3

    any change or addition of new PH medication including dosing in time

  3. Long-term change in risk status

    Time frame: up to year 3

    Risk status measured by simplified four-strata risk-assessment tool

  4. Long-term change in WHO FC

    Time frame: up to year 3

    World Health Organization Functional Class (WHO FC) is categorized from I (no symptoms) to IV (severe dyspnea and symptoms)

  5. Long-term change in BDS

    Time frame: up to year 3

    BDS - Borg Dyspnea Score, ranging from 0 (no exertion) to 10 (maximum)

  6. Long-term change in NT-proBNP/BNP

    Time frame: up to year 3

    NT-proBNP/BNP: N-terminal pro Brain Natriuretic Peptide

  7. Long-term change in Pulmonary Vascular Resistance (PVR)

    Time frame: up to year 3

    PVR to be measured in WU Parameter will be collected according to clinical routine

  8. Long-term change in mean Pulmonary Arterial Pressure (mPAP)

    Time frame: up to year 3

    mPAP to be measured in mmHg Parameter will be collected according to clinical routine

  9. Long-term change in Right Atrial Pressure (RAP)

    Time frame: up to year 3

    RAP to be measured in mmHg Parameter will be collected according to clinical routine

  10. Long-term change in mean Right Atrial Pressure (mRAP)

    Time frame: up to year 3

    mean Right Atrial Pressure (mRAP) to be measured in mmHg Parameter will be collected according to clinical routine

  11. Long-term change in Cardiac Index (CI)

    Time frame: up to year 3

    Cardiac index (CI) measured in liters per minute per square meter Parameter will be collected according to clinical routine

  12. Long-term change in Cardiac Output (CO)

    Time frame: up to year 3

    Cardiac output (CO) measured in liters per minute Parameter will be collected according to clinical routine

  13. Long-term change in Pulmonary capillary wedge pressure (PCWP)

    Time frame: up to year 3

    Pulmonary capillary wedge pressure (PCWP) measured in mmHg Parameter will be collected according to clinical routine

  14. Long-term change in Stroke volume index (SVI)

    Time frame: up to year 3

    Parameter will be collected according to clinical routine

  15. Long-term change in RV-PA coupling

    Time frame: up to year 3

    RV-PA coupling estimated by the ratio of tricuspid annular plane systolic excursion by pulmonary artery systolic pressure Parameter will be collected according to clinical routine

  16. Long-term change in RV end-diastolic area (RVEDA)

    Time frame: up to year 3

    RV end-diastolic area (RVEDA) measured in square centimeters Parameter will be collected according to clinical routine

  17. Long-term change in RV end-systolic area (RVESA)

    Time frame: up to year 3

    RV end-systolic area (RVESA) measured in square centimeters Parameter will be collected according to clinical routine

  18. Long-term change in RV fractional area change (RVFAC)

    Time frame: up to year 3

    RV fractional area change (RVFAC) calculated in % Parameter will be collected according to clinical routine

  19. Long-term change in Right Atrium (RA) area

    Time frame: up to year 3

    Right Atrium (RA) area in square centimeters Parameter will be collected according to clinical routine

  20. Long-term change in Pericardial effusion

    Time frame: up to year 3

    Pericardial effusion assessment will be done and rated as yes/no Parameter will be collected according to clinical routine

  21. Long-term change in Right ventricular ejection fraction (RVEF)

    Time frame: up to year 3

    Parameter will be collected according to clinical routine

Other outcomes

  1. Frequency and seriousness of adverse events (AE) and adverse drug reactions (ADR)

    Time frame: up to year 3

    This includes:

    • Adverse events (S)AEs
    • Adverse drug reactions (S)ADRs related to any of PAH treatments
    • Adverse events related to underlying diagnosis, PAH

  2. Long-term change in QoL using European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire

    Time frame: up to year 3

    The EQ-5D-5L questionnaire consists of 2 parts - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. It should be noted that the numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.

  3. Long-term change in QoL using PAH-specific emPHasis-10 questionnaire

    Time frame: up to year 3

    Emphasis meaning something of special importance or significance. Please translate using the most appropriate term. The PH in emPHasis represents the condition Pulmonary Hypertension. The number 10 refers to the number of items in the questionnaire.

    This questionnaire is designed to determine how Pulmonary Hypertension (PH) affects patient's life. It refers to how PH affects or the impact that PH has on the patient's life.

Sponsors and collaborators

Lead sponsor

AOP Orphan Pharmaceuticals AG

Industry

Registry information

Official study title

A Prospective, Multicenter, International Non-interventional, Observational Cohort Study to Observe Long-term Treatment Patterns and Real-word Outcomes in PAH Group I Patients Previously Participating in TripleTRE - TripleTRE-NIS

Acronym: TripleTRE-NIS

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jun 6, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.