Clinical trial NCT06703801: Evaluation of the Progression of Disease and Health-related Quality of Life in Patients With Pulmonary Hypertension: A Local Clinic-based Registry
Official title: Evaluation of the Progression of Disease and Health-related Quality of Life in Patients With Pulmonary Hypertension: A Local Clinic-based Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Six-minute walking test
NT-proBNP
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with echocardiographic confirmation of increased pulmonary pressure referred for evaluation and management of PH at the Prince of Wales Hospital ambulatory cardiac clinic will be recruited into this registry. Patients' consent will be sought from either the patients or their legal guardian should the patients deemed incapable to consent.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality
timeFrame: 3-monthly
measure: WHO functional class
timeFrame: 3-monthly
measure: EMPASIS-10 questionnaires
timeFrame: 3-monthly
measure: pulmonary hypertension related mortality
timeFrame: 3-monthly
measure: Borg Rating of perceived exertion (RPE) scale
timeFrame: 3-monthly
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: 3-monthly
measure: The Modified Medical Research Council (mMRC) Dyspnea scale
timeFrame: 3-monthly
measure: Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL)
timeFrame: 3-monthly
Secondary outcomes:
measure: physical parameters
timeFrame: 3-monthly
measure: daily activity level
timeFrame: 3-monthly
measure: Natriuretic Peptide Tests (NT-proBNP) level
timeFrame: 3-monthly
measure: Six-minute walking test (6MWT)
timeFrame: 3-monthly
measure: Right Ventricular Systolic Pressure (RVSP) as echocardiographic parameters
timeFrame: 3-monthly
measure: hemodynamic parameters
timeFrame: 3-monthly
measure: PH specific medications number and dosage
timeFrame: 3-monthly
measure: costs of all services, medications and tests
timeFrame: 3-monthly
measure: clinical parameters
timeFrame: 3-monthly
measure: laboratory parameters
timeFrame: 3-monthly
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital, Hong Kong, Hong Kong
Study officials:
References: