Clinical Professor
Christian B. Laursen
Department of Respiratory Medicine
| Project management | ||
| Project status | Open | |
| Data collection dates | ||
| Start | - | |
| End | - | |
The CODEX-P Trial - COPD exacerbation and Pulmonary Hypertension Trial
Short summary
The study aims to determine whether right-sided heart pressures are elevated during hospitalization with COPD exacerbations compared to stable phase. Additionally, to find out if there is an association between tricuspid regurgitation (TR) gradient and days alive and out of the hospital (DAOH).
Rationale
Background: Little is known about the pressure in the right side of the heart during chronic obstructive pulmonary disease (COPD) exacerbations, despite its potential impact on patient outcomes. Increased right heart pressures can lead to right ventricular dysfunction, which may worsen respiratory status and overall morbidity in COPD patients. Aim: To determine whether right-sided heart pressures are elevated during hospitalization with COPD exacerbations compared to stable phase. Additionally, to find out if there is an association between tricuspid regurgitation (TR) gradient and days alive and out of the hospital (DAOH).
Description of the cohort
Inclusion criteria: - COPD (verified by a lung specialist based on clinical assessment and spirometry) - Acute hospitalization, primary diagnosis "AECOPD" - Change in TR gradient of ≥ 5 mmHG from baseline to day 30, assessed by echocardiography by a specialist in cardiology or a senior consultant with a special interest in echocardiography 10 - Informed consent Exclusion criteria: - Known pulmonary hypertension - Known heart disease that affects the pumping function of the heart (left or right) - Male <40 years - Women <55 years - Non-menopausal women> 55 years* - Severe mental illness which significantly complicates cooperation - Severe language problems which significantly complicate cooperation - Known drug allergy to 1) Sildenafil - Get Sildenafil on other indication with consumption ≥50 mg/week *Definition: Had menstruation within the last 12 months
Data and biological material
Echocardiography will be performed on patients at baseline (<24 hours after admission and the diagnosis of AECOPD) and also on days 11 (10 days after baseline) and 29 (28 days after baseline). On the first 50 participating patients, a blood sample will be taken at baseline and on day 29. The blood sample is thrombelastography (TEG), and the purpose is to examine the coagulation capacity of the blood. The TEG sample is analyzed on the same day. The patients' course is followed up to and including day 90 after baseline.
Collaborating researchers and departments
1st Department of Pulmonary Medicine, Gentofte hospital