Pulmonaryhypertension in Copd at Different Levels of Smoking

September 13, 2023 updated by: Shrouk Mohamed Salah Mosleh, Assiut University

Clinical Characteristics and Predictors of Pulmonary Hypertension in COPD at Different Levels of Smoking

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

Study Overview

Status

Not yet recruiting

Detailed Description

COPD is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.It is also the most common cause of deaths in patients with chronic respiratory disease, the fatality rate in USA is 0.41%.Pulmonary Hypertension is the most common serious complication in COPD patients ; which occurs in up to 30% of patients and increases the mortality rate.Smoking is the leading cause of chronic obstructive pulmonary disease (COPD) Smoking is also a trigger for COPD flare-ups.Smoking damages the air sacs, airways, and the lining of your lungs. Injured lungs have trouble moving enough air in and out, so it's hard to breathe

Study Type

Observational

Enrollment (Estimated)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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]

Description

Inclusion Criteria:

  • 1.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

Exclusion Criteria:

  • 1.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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of pulmonary hypertension in COPD patients
Time Frame: 1 year
Predict pulmonary hypertension in COPD patients
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between different levels of smoking and predictors of degree of pulmonary hypertension
Time Frame: 1 year
Levels of smoking (mild.moderate.sever.non smoker) and it's relation to pulmonary hypertension in COPD patients
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 2, 2023

First Submitted That Met QC Criteria

September 2, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Pulmonaryhypertension in copd

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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