| Registry | NCT04538976, acronym CODEX-P |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 250 (Actual) |
| Sponsor | Chronic Obstructive Pulmonary Disease Trial Network, Denmark (Other) |
| Conditions | Acute Exacerbation of COPD |
| Interventions | Sildenafil (Drug) |
| Dates | start 2020-02-01, primary completion 2024-03-15, completion 2024-03-15, first posted 2020-09-04, last updated 2025-03-13 |
| Locations | 5 sites in Denmark |
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All trials for Acute Exacerbation of COPD All trials of Sildenafil
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control | No intervention | Patients in the control group will receive standard care. | |
| Sildenafil | Active comparator | Drug: Sildenafil | Patients in the Sildenafil group will receive standard care and targeted Sildenafil-treatment. |
Sex: All, ages: 40 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Bispebjerg University Hospital | Copenhagen | Denmark | |
| Herlev-Gentofte Hospital | Copenhagen | Denmark | |
| Hvidovre Hospital | Copenhagen | Denmark | |
| Nordsjællands Hospital | Hillerød | Denmark | |
| Odense Universitetshospital | Odense | Denmark |