NCT06365372

Brief Summary

The aim of the study is to observe the change of the circulating MrgD level in patients with pulmonary hypertension compared with subjects without pulmonary hypertension.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

April 10, 2024

Last Update Submit

April 10, 2024

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Circulating MrgD level

    From 2022 to 2024

Study Arms (2)

PAH

Diagnostic Test: Western blot

Non-PAH

Diagnostic Test: Western blot

Interventions

Western blotDIAGNOSTIC_TEST

Samples were measured by Western blot using a solution for the separation of lymphocytes from peripheral blood.

Non-PAHPAH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pulmonary hypertension and control subjects

You may qualify if:

  • Male or female aged ≥18 years
  • Right heart catheterisation to check the mean pulmonary artery pressure (mPAP) ≥25mmHg
  • The patient is willing and able to provide written informed consent.

You may not qualify if:

  • Age less than 18 years old
  • Mean pulmonary artery pressure (mPAP) \<25mmHg
  • Unable to provide informed written consent for participation in the study
  • Renal insufficiency
  • Liver insufficiency
  • Malignant tumor
  • Active infection
  • Pregnancy
  • Male or female aged ≥18 years
  • No evidence of pulmonary hypertension on echocardiography or mean pulmonary artery pressure (mPAP) \< 25 mmHg on right heart catheterization, and no evidence of clinically relevant heart disease
  • No evidence of clinically relevant pulmonary disease
  • Age less than 18 years old
  • Mean pulmonary artery pressure (mPAP) ≥25mmHg
  • Unable to provide informed written consent for participation in the study
  • Symptoms of heart failure or clinically relevant lung disease
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Panpan Hao, MD

CONTACT

8618560086593panda.how@sdu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 15, 2024

Study Start

April 10, 2024

Primary Completion

May 10, 2024

Study Completion

June 1, 2024

Last Updated

April 15, 2024

Record last verified: 2024-04

Locations

CN(1)