Acute Exacerbation of COPD
Conditions
Keywords
COPD, Chronic Obstructive Lung Disease, Increased pulmonary pressure, Acute Exacerbation, AECOPD
Brief summary
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
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.
Interventions
DRUGSildenafil
Sildenafil in standard dosage
Sponsors
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is a multicenter controlled, randomized, open-lapel trial.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time alive and out of hospital | 365 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Time to prednisolon and/or antibiotica-needing exacerbation of COPD or death | 365 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 |
| Delta Pa(O2) | 4 days |
Countries
Denmark
Outcome results
None listed