Clinical trial NCT04538976: Copd Exacerbation and Pulmonary Hypertension Trial
Official title: Copd Exacerbation and Pulmonary Hypertension Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Exacerbation of COPD
Keywords: COPD
Chronic Obstructive Lung Disease
Increased pulmonary pressure
Acute Exacerbation
AECOPD
Lead sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a multicenter controlled, randomized, open-lapel trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time alive and out of hospital
timeFrame: 365 days
Secondary outcomes:
measure: Time to "prednisolon and/or antibiotica"-needing exacerbation of COPD or death
timeFrame: 365 days
measure: Death within 90 days
timeFrame: 90 days
measure: Death within 1 year
timeFrame: 365 days
measure: Alive and without exacerbation of COPD on day 365
timeFrame: 365 days
measure: Clinical cure
timeFrame: 14 days
measure: Number of readmissions due to exacerbations of COPD
timeFrame: 365 days
measure: Number of days with non-invasive ventilation (NIV) or respirator during admittance
timeFrame: 14 days
measure: Delta Pa(O2)
timeFrame: 4 days
measure: Delta Pa(CO2)
timeFrame: 4 days
measure: Delta(pH)
timeFrame: 4 days
measure: Change in FEV1
timeFrame: 90 days
measure: Change in COPD Assesment Test (CAT)
timeFrame: 29 days
measure: Change in Body Mass Index (BMI)
timeFrame: 90 days
measure: Delta(TR-gradient)
timeFrame: 4 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg University Hospital
city: Copenhagen
country: Denmark
facility: Herlev-Gentofte Hospital
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
Study officials:
References: