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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• All-cause mortality [Срок оценки: 3-monthly]
• WHO functional class [Срок оценки: 3-monthly]
• EMPASIS-10 questionnaires [Срок оценки: 3-monthly]
• pulmonary hypertension related mortality [Срок оценки: 3-monthly]
• Borg Rating of perceived exertion (RPE) scale [Срок оценки: 3-monthly]
• The 5-level EQ-5D version (EQ-5D-5L) [Срок оценки: 3-monthly]
• The Modified Medical Research Council (mMRC) Dyspnea scale [Срок оценки: 3-monthly]
• Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL) [Срок оценки: 3-monthly]

Вторичные конечные точки (10)

• physical parameters [Срок оценки: 3-monthly]
• daily activity level [Срок оценки: 3-monthly]
• Natriuretic Peptide Tests (NT-proBNP) level [Срок оценки: 3-monthly]
• Six-minute walking test (6MWT) [Срок оценки: 3-monthly]
• Right Ventricular Systolic Pressure (RVSP) as echocardiographic parameters [Срок оценки: 3-monthly]
• hemodynamic parameters [Срок оценки: 3-monthly]
• PH specific medications number and dosage [Срок оценки: 3-monthly]
• costs of all services, medications and tests [Срок оценки: 3-monthly]
• clinical parameters [Срок оценки: 3-monthly]
• laboratory parameters [Срок оценки: 3-monthly]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Гонконг · 1 центр

• Prince of Wales Hospital, Hong Kong, Hong Kong — Гонконг

Идентификаторы

NCT: NCT06703801 · 2024.290

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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