Copd Exacerbation and Pulmonary Hypertension Trial

Last updated: March 11, 2025
Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Overall Status: Completed

Phase

4

Condition

Stress

Vascular Diseases

Circulation Disorders

Treatment

Sildenafil

Clinical Study ID

NCT04538976
Study_protocol_CODEX-P_ver2_1
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 12months.)

  • 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

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Sildenafil
Phase: 4
Study Start date:
February 01, 2020
Estimated Completion Date:
March 15, 2024

Study 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.

Connect with a study center

  • Bispebjerg University Hospital

    Copenhagen,
    Denmark

    Site Not Available

  • Herlev-Gentofte Hospital

    Copenhagen,
    Denmark

    Site Not Available

  • Hvidovre Hospital

    Copenhagen,
    Denmark

    Site Not Available

  • Nordsjællands Hospital

    Hillerød,
    Denmark

    Site Not Available

  • Odense Universitetshospital

    Odense,
    Denmark

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.