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

NCT06703801 | Enrolling By Invitation

• 1 other identifier: 2024.290
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension; Six-minute walking test; NT-proBNP

Outcome Measures

Primary Outcomes (8)

• All-cause mortality

  All-cause mortality

  3-monthly

• WHO functional class

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

  3-monthly

• EMPASIS-10 questionnaires

  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

  3-monthly

• pulmonary hypertension related mortality

  pulmonary hypertension related mortality

  3-monthly

• Borg Rating of perceived exertion (RPE) scale

  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

  3-monthly

• The 5-level EQ-5D version (EQ-5D-5L)

  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

  3-monthly

• The Modified Medical Research Council (mMRC) Dyspnea scale

  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

  3-monthly

• Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL)

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

  3-monthly

Secondary Outcomes (10)

• physical parameters

  3-monthly

• daily activity level

  3-monthly

• Natriuretic Peptide Tests (NT-proBNP) level

  3-monthly

• Six-minute walking test (6MWT)

  3-monthly

• Right Ventricular Systolic Pressure (RVSP) as echocardiographic parameters

  3-monthly

Study Arms (1)

Patients at the Prince of Wales Hospital ambulatory cardiac clinic

Patients age \> 18 with echocardiographic confirmation of increased pulmonary pressure (eg. estimated RVSP \>40mmHg, evidence of RV dilatation etc) and able to attend at the Prince of Wales Hospital ambulatory cardiac clinic

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, Hong Kong, Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): November 5, 2029
• Study Completion (Estimated): February 5, 2030
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

HK (1)