NCT06031311

Brief Summary

To identify Predictors of pulmonary hypertension in COPD patients and its relation to different levels of smoking

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 2, 2023

Last Update Submit

September 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Predictors of pulmonary hypertension in COPD patients

    Predict pulmonary hypertension in COPD patients

    1 year

Secondary Outcomes (1)

  • Relationship between different levels of smoking and predictors of degree of pulmonary hypertension

    1 year

Interventions

Echocardiography:is non invasive and easily accessible tool in the diagnosis of any patient with suspected PH.HRCT: is a non-invasive and easily accessible tool to detect pulmonary hypertension in COPD patients.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Full clinical history including:\[demographic data and clinical symptoms including cough with expectoration ,dyspnea,chest wheeze,…etc\] 2.Full clinical examination. 3.laboratory investigations: Complete blood picture , kidney function test, liver function test,coagulation profile 4.Arterial blood gases \[Pao2, Paco2,Sao2,Hco3, P(A\_a)o2 \] 5.PFTS:will be performed and classified into: Post bronchodilator FEV1/FVC \<0.7 GOLD 1 - mild: FEV1 ≥80% predicted. GOLD 2 - moderate: 50% ≤ FEV1 \<80% predicted. GOLD 3 - severe: 30% ≤ FEV1 \<50% predicted. GOLD 4 - very severe: FEV1 \<30% predicted \[5\] 6.Echocardiography:is non invasive and easily accessible tool in the diagnosis of any patient with suspected PH. ePASP is estimated by calculating Doppler estimated trans tricuspid gradient (TR gradient= 4 x (TR velocity)2) and adding estimated right atrial pressure to it based on the size of the inferior vena cava and collapsibility.\[6\]

You may qualify if:

  • All patients admitted to chest department or presented to our outpatient clinic with clinical and functional diagnosis of COPD among both sexes will be included 2.Age \>18 years Old

You may not qualify if:

  • Patients under 18 years old. 2.pregnant patients. 3.patients with history hypertension or valvular diseases 4.Cardiomyopathic patient 5.Patients with concomitant obstructive sleep apnea 6.Patients with collagen vascular disease 7.Patients with thrombo-embolic disease 8. Patients with any chronic chest disease other than COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Shrouk Mohamed Salah, Resident physician

CONTACT

Marwan Nasr Sleem, Lecturer of Chest diseases and

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 11, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

September 14, 2023

Record last verified: 2023-09