Evaluation of the Progression of Disease and Health-related Quality of Life in Patients With Pulmonary Hypertension: A Local Clinic-based Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- All-cause mortality [Time frame: 3-monthly]
- WHO functional class [Time frame: 3-monthly]
- EMPASIS-10 questionnaires [Time frame: 3-monthly]
- pulmonary hypertension related mortality [Time frame: 3-monthly]
- Borg Rating of perceived exertion (RPE) scale [Time frame: 3-monthly]
- The 5-level EQ-5D version (EQ-5D-5L) [Time frame: 3-monthly]
- The Modified Medical Research Council (mMRC) Dyspnea scale [Time frame: 3-monthly]
- Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL) [Time frame: 3-monthly]
Secondary outcome measures (10)
- physical parameters [Time frame: 3-monthly]
- daily activity level [Time frame: 3-monthly]
- Natriuretic Peptide Tests (NT-proBNP) level [Time frame: 3-monthly]
- Six-minute walking test (6MWT) [Time frame: 3-monthly]
- Right Ventricular Systolic Pressure (RVSP) as echocardiographic parameters [Time frame: 3-monthly]
- hemodynamic parameters [Time frame: 3-monthly]
- PH specific medications number and dosage [Time frame: 3-monthly]
- costs of all services, medications and tests [Time frame: 3-monthly]
- clinical parameters [Time frame: 3-monthly]
- laboratory parameters [Time frame: 3-monthly]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital, Hong Kong, Hong Kong — Hong Kong
Identifiers
NCT: NCT06703801 · 2024.290