Pulmonary HypertensionNCT06031311
Pulmonaryhypertension in Copd at Different Levels of Smoking
An observational study of Pulmonary Hypertension, run by Assiut University.
Trial summary
To identify Predictors of pulmonary hypertension in COPD patients and its relation to different levels of smoking Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Echocardiography and HRCT
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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]
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Conditions
- Pulmonary Hypertension
- Being tested
- Echocardiography and HRCT
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography and HRCTDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of pulmonary hypertension in COPD patients
Predict pulmonary hypertension in COPD patients
Measured: 1 year
Secondary outcomes (1)
Relationship between different levels of smoking and predictors of degree of pulmonary hypertension
Levels of smoking (mild.moderate.sever.non smoker) and it's relation to pulmonary hypertension in COPD patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrouk Mohamed Salah Mosleh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031311
- Sponsor's protocol ID
- Pulmonaryhypertension in copd
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Predictors of Pulmonary Hypertension in COPD at Different Levels of Smoking
- ClinicalTrials.gov ID
- NCT06031311
- Acronym / sponsor ID
- Pulmonaryhypertension in copd
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify Predictors of pulmonary hypertension in COPD patients and its relation to different levels of smoking
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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]
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography and HRCTEchocardiography: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. | Diagnostic test | – |
Primary outcome
Predictors of pulmonary hypertension in COPD patients
Time frame: 1 year
Predict pulmonary hypertension in COPD patients
1 secondary outcome
Relationship between different levels of smoking and predictors of degree of pulmonary hypertension
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Global Initiative for Chronic Obstructive Lung Disease 2023Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shrouk Mohamed Salah, Resident physician (01150637673, Shrouksalah806@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of pulmonary hypertension in COPD patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.