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Enrolling by Invitation

NCT Number: NCT06703801

Evaluation of the Progression of Disease and Health-related Quality of Life in Patients With Pulmonary Hypertension: A Local Clinic-based Registry

Pulmonary Hypertension (PH) is a multifaceted disease and is associated with significant morbidity and mortality if untreated1. Diagnosing PH can be challenging and often delayed2. Multiple international registries included REVEAL3 and COMPERA4 have all demonstrated that diagnostic delay and suboptimal treatment prescription led poor 1 year-survival in patient with PH. In recent years, significant progress has been made in diagnosing, risk stratification, and treatment for patients with PH1. A dedicated PH service has been established in ambulatory clinic to streamline the management of these complex patients. This registry therefore aims to investigate the progression disease and its impact on the quality of life (QoL) of the patients who are managed at the dedicated PH clinic.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital, Hong Kong, Hong Kong

Hong Kong

About this study

Pulmonary Hypertension (PH) is a multifaceted disease and is associated with significant morbidity and mortality if untreated1. Diagnosing PH can be challenging and often delayed2. Multiple international registries included REVEAL3 and COMPERA4 have all demonstrated that diagnostic delay and suboptimal treatment prescription led poor 1 year-survival in patient with PH. In recent years, significant progress has been made in diagnosing, risk stratification, and treatment for patients with PH1. A dedicated PH service has been established in ambulatory clinic to streamline the management of these complex patients. This registry therefore aims to investigate the progression disease and its impact on the quality of life (QoL) of the patients who are managed at the dedicated PH clinic.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients age > 18 with echocardiographic confirmation of increased pulmonary pressure (eg. estimated RVSP >40mmHg, evidence of RV dilatation etc), and no apparent reversible causes.
  • Patients with reasonable pre-morbids and is able to attend ambulatory clinic.

Exclusion criteria

  • Inability to provide valid consent by the patient or his legal guardian

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 3-monthly

    All-cause mortality

  2. WHO functional class

    Time frame: 3-monthly

    Change in functional class (class I as the mildest to class IV as more severe) as measured by WHO functional class over times

  3. EMPASIS-10 questionnaires

    Time frame: 3-monthly

    Change in disease-specific health-related quality of life (QoL) as measured by EMPASIS-10 questionnaires which is an independent prognostic marker in patients with (I/D/H)PAH or CTD-PAH

  4. pulmonary hypertension related mortality

    Time frame: 3-monthly

    pulmonary hypertension related mortality

  5. Borg Rating of perceived exertion (RPE) scale

    Time frame: 3-monthly

    Change in disease-specific health-related quality of life (QoL) as measured by Borg RPE scale which is an outcome measure scale used to gauge one's exercise intensity without the need to rely on physiological parameters

  6. The 5-level EQ-5D version (EQ-5D-5L)

    Time frame: 3-monthly

    Change in disease-specific health-related quality of life (QoL) as measured by EQ-5D-5L which is for assessing patient health states for clinical and economic appraisal

  7. The Modified Medical Research Council (mMRC) Dyspnea scale

    Time frame: 3-monthly

    Change in disease-specific health-related quality of life (QoL) as measured by mMRC which use to access stratifies severity of dyspnea in respiratory diseases, particularly COPD

  8. Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL)

    Time frame: 3-monthly

    Change in disease-specific health-related quality of life (QoL) as measured by PEmb-QoL which use to access QoL following PE

Secondary outcomes

  1. physical parameters

    Time frame: 3-monthly

    Change in physical parameters

  2. daily activity level

    Time frame: 3-monthly

    Change in daily activity level

  3. Natriuretic Peptide Tests (NT-proBNP) level

    Time frame: 3-monthly

    Change from baseline in log-transformed NT-proBNP level over time

  4. Six-minute walking test (6MWT)

    Time frame: 3-monthly

    Change in Six-minute walking test (6MWT)

  5. Right Ventricular Systolic Pressure (RVSP) as echocardiographic parameters

    Time frame: 3-monthly

    Change in RVSP as echocardiographic parameters

  6. hemodynamic parameters

    Time frame: 3-monthly

    Change in hemodynamic parameters

  7. PH specific medications number and dosage

    Time frame: 3-monthly

    Change of PH specific medications number and dosage over time, including PDE5 inhibitor, Guanyl Cyclase stimulator, Endothelin Receptor antagonist, prostacyclin receptor agonist, and inhaled prostacyclin.

  8. costs of all services, medications and tests

    Time frame: 3-monthly

    The costs of all services, medications and tests as estimated with reference to the Hong Kong Government Gazette 2020 and Hong Kong Hospital Authority Drug Formulary 2020

  9. clinical parameters

    Time frame: 3-monthly

    Change in physical parameters

  10. laboratory parameters

    Time frame: 3-monthly

    Change in laboratory parameters

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Nov 25, 2024
Registry last updated
Nov 25, 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.

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