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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients in the control group will receive standard care. | |
| Sildenafil | Active Comparator | Patients in the Sildenafil group will receive standard care and targeted Sildenafil-treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | Sildenafil in standard dosage |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time alive and out of hospital | 365 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg University Hospital | Copenhagen | Denmark | ||||
| Herlev-Gentofte Hospital |
We have not yet decided to share IPD.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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The study is a multicenter controlled, randomized, open-lapel trial.
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| 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 |
| Copenhagen |
| Denmark |
| Hvidovre Hospital | Copenhagen | Denmark |
| Nordsjællands Hospital | Hillerød | Denmark |
| Odense Universitetshospital | Odense | Denmark |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |