Copd Exacerbation and Pulmonary Hypertension Trial

Phase 4

Completed

• Conditions: Acute Exacerbation of COPD
• Interventions: Drug: Sildenafil

• Registration Number: NCT04538976
• Lead Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-08-30
• Study First Submitted QC: 2020-08-30
• Study First Posted: 2020-09-04
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil	Sildenafil	Patients in the Sildenafil group will receive standard care and targeted Sildenafil-treatment.

Primary Outcome Measures

Name	Time	Method
Time alive and out of hospital	365 days

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Bispebjerg University Hospital; 🇩🇰 Copenhagen, Denmark

Herlev-Gentofte Hospital; 🇩🇰 Copenhagen, Denmark

Hvidovre Hospital; 🇩🇰 Copenhagen, Denmark

Nordsjællands Hospital; 🇩🇰 Hillerød, Denmark

Odense Universitetshospital; 🇩🇰 Odense, Denmark