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NCT04538976 Clinical Trial

Copd Exacerbation and Pulmonary Hypertension Trial

Acute Exacerbation of COPD Clinical Trial

— CODEX-P  

Official title:
Copd Exacerbation and Pulmonary Hypertension Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04538976
Other study ID # Study_protocol_CODEX-P_ver2_1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date February 1, 2020
Est. completion date October 31, 2025

Study information
Verified date August 2023
Source Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Contact Pradeesh Sivapalan, PhD
Phone 004538673513
Email pradeesh.sivapalan.01@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2
Est. completion date October 31, 2025
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Sildenafil
Sildenafil in standard dosage

Locations
Country Name City State
Denmark Bispebjerg University Hospital Copenhagen
Denmark Herlev-Gentofte Hospital Copenhagen
Denmark Hvidovre Hospital Copenhagen
Denmark Nordsjællands Hospital Hillerød
Denmark Odense Universitetshospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Country where clinical trial is conducted

Denmark, 

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