Copd Exacerbation and Pulmonary Hypertension Trial

Study Overview
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Brief Summary
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This trial will investigate whether patiens admitted with an acute exacerbation of chronic obstructive lung disease and pulmonary hypertension will benefit from a targeted pharmacological treatment.

Detailed Description
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During admittance due to acute exacerbation of chronic obstructive lung disease will patience have an echocardiography to examine their pulmonary pressure. If patient have a tricuspidal return gradient above 40 mmHg, they will receive treatment with a phosphordiesterase-5-inhibitor, Sildenafil.

Official Title
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Copd Exacerbation and Pulmonary Hypertension Trial

Conditions
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Acute Exacerbation of COPD

Intervention / Treatment
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* Drug: Sildenafil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD verified by specialist and spirometry Admitted with the diagnosis acute exacerbation of COPD TR-gradient ≥40 mmHg verified by specialist and echocardiography Informed consent Exclusion Criteria: Known pulmonal hypertension Known heart disease which affects the pump function of the heart Men <40 years Women <55 years Not-menopauseal women <55 years (Menopause is defined as no menstruation within 12 months.) Severe mental illness which significantly complicates cooperation Severe language difficulties which significantly complicates cooperation known allergy to Sildenafil Sildenafil consumption ≥50 mg / week due to other indications

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a multicenter controlled, randomized, open-lapel trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients in the control group will receive standard care. | |
| Active Comparator: Sildenafil<br>Patients in the Sildenafil group will receive standard care and targeted Sildenafil-treatment. | Drug: Sildenafil<br>* Sildenafil in standard dosage<br>* Other names: Vizarsin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time alive and out of hospital |  | 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to prednisolon and/or antibiotica-needing exacerbation of COPD or death |  | 365 days | 
| Death within 90 days |  | 90 days | 
| Death within 1 year |  | 365 days | 
| Alive and without exacerbation of COPD on day 365 |  | 365 days | 
| Clinical cure |  | 14 days | 
| Number of readmissions due to exacerbations of COPD |  | 365 days | 
| Number of days with non-invasive ventilation (NIV) or respirator during admittance |  | 14 days | 
| Delta Pa(O2) |  | 4 days | 
| Delta Pa(CO2) |  | 4 days | 
| Delta(pH) |  | 4 days | 
| Change in FEV1 |  | 90 days | 
| Change in COPD Assesment Test (CAT) |  | 29 days | 
| Change in Body Mass Index (BMI) |  | 90 days | 
| Delta(TR-gradient) |  | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Chronic Obstructive Lung Disease, Increased pulmonary pressure, Acute Exacerbation, AECOPD