Risk Factor Assessment for Acute Pulmonary Hypertension Crisis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking Union Medical College Hospital
About this trial
The goal of this observational study is to learn about pulmonary hypertension crisis (PHC) - a severe, and often fatal complication - in patients with pulmonary hypertension (PH). The main questions this study aims to answer are:
What are the clinical and hemodynamic features of PHC, and what underlying pathophysiological mechanisms cause it to develop? Can these features be used to diagnostic PHC, predict who is at risk of developing it or dying from it, and develop targeted prevention and treatment of PHC?
A multi-center registry platform and biobank will be established to enroll and follow up patients with PH. Clinical data, hemodynamic measurements, and biological specimen will be collected. Risk prediction and early warning tools of PHC will be developed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pulmonary hypertension confirmed by mean pulmonary arterial pressure (mPAP) over 20 mmHg measured by right heart catheter
At least once per year of follow-up data collection record
Disqualifiers
Patients with missing baseline or follow-up data
Complicated by other diseases with significant influence on survival, such as acute coronary syndrome, malignancy, etc.
Complicated by other diseases with significant influence on hemodynamics, such as sepsis, acute left heart failure, and acute pulmonary embolism, etc.
Receiving medications with significant influence on hemodynamics
Trial population
Patients with pulmonary hypertension confirmed by right heart catheterization
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: Pulmonary hypertension
Trial outcomes
Primary outcomes
1
Pulmonary hypertension crisis
Critical increase of pulmonary vascular resistance accompanied by right heart dysfunction and systemic hypoperfusion
Time frame
From enrollment to 3 years after enrollment2
28 day mortality attributed to pulmonary hypertension crisis
Death attributed to pulmonary hypertension crisis within 28 days of hospitalization
Time frame
From hospitalization to 28 daysSecondary outcomes
1
All cause mortality within hospitalization
All cause death within hospitalization
Time frame
From hospitalization to discharge or documented death, whichever is earlier, assessed up to 3 years2
All cause mortality within 3 years
All cause death within 3 years from the diagnosis of pulmonary hypertension crisis
Time frame
From the diagnosis of pulmonary hypertension crisis to documented death, assessed up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov