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NCT Number: NCT06135909

CHASE Registry of Patients With Pulmonary Hypertension Receiving Targeted Therapy

CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy (CHASE Study)

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC

Beijing, 100037, China

Location status: Recruiting

Location contact

Zhihong Liu, MD,PhD

CONTACT

[email protected]

+861088396590

Zhihong Liu, MD,PhD

PRINCIPAL_INVESTIGATOR

About this study

The purpose of this study was to establish the clinical characteristics and treatment strategies of targeted pulmonary hypertension patients in China: a multicenter, prospective case registry (CHASE) study to describe the clinical characteristics, treatment used, disease progression, and outcomes (e.g., death, hospitalization) of patients taking targeted drugs in real-world clinical practice. This study will collect high-quality real-world data that can be used as a standalone dataset or combined with other data sources to address critical issues in the PH field.

This is a prospective, observational, multicenter study. The expected number of enrolled cases for the entire study: at least 5000; No experimental group and control group were divided. Patients were followed up every 6 months ±2 weeks after enrollment for 3 years. The study selected patients who signed informed consent, aged 18-25 years, clinically diagnosed with pulmonary hypertension, and were applying or planning to apply targeted drugs for pulmonary hypertension as the study objects. The primary endpoint was the incidence of clinical exacerbations at 1 year after enrollment. Secondary endpoints were all-cause mortality at 1, 2, and 3 years after enrollment, rate of lung transplantation or combined cardiopulmonary transplantation, 6-minute walking distance, NT-proBNP level, WHO cardiac function grade, ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter, pulmonary hypertension targeted drug regimen, and incidence of associated adverse reactions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign informed consent;
  • Between the ages of 18 and 85;
  • Clinical diagnosis of pulmonary hypertension, using or planning to use pulmonary hypertension targeted drugs (including any one or more of the following: prostacyclin analogues, endothelin receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase agonists and prostacyclin receptor agonists).

Exclusion criteria

  • Have a history of mental illness or drug or poison addiction, and can not sign informed consent or can not cooperate with the experimental study;
  • Patients with malignant tumor and other diseases and life expectancy of less than half a year;
  • Short-term (less than 2 weeks) patients taking targeted drugs for pulmonary hypertension

Treatment and study plan

Primary outcomes

  1. Incidence of clinical worsening events 1 year after enrollment

    Time frame: 1 year after enrollment

    All-cause death, Pulmonary hypertension progression associated with re-hospitalization, Progress of pulmonary hypertension disease

Secondary outcomes

  1. Incidence of all-cause death 1,3,5 year(s) after enrollment

    Time frame: 1,3,5 year(s) after enrollment

    Incidence of all-cause death 1,3,5 year(s) after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Zhihong Liu, M.D., Ph.D

CONTACT

[email protected]

8601088396816

Sponsors and collaborators

Lead sponsor

Chinese Pulmonary Vascular Disease Research Group

Other

Registry information

Official study title

CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Jan 18, 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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