Copd Exacerbation and Pulmonary Hypertension Trial (CODEX-P)

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Status and phase

Completed

Phase 4

Conditions

Acute Exacerbation of COPD

Treatments

Drug: Sildenafil

Study type

Interventional

Funder types

Other

Identifiers

NCT04538976

Study_protocol_CODEX-P_ver2_1

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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