Clinical Trials

Copd Exacerbation and Pulmonary Hypertension Trial

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04538976
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acute Exacerbation of COPD

Additional Details

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.

Arms & Interventions

Arms

No Intervention: Control

Patients in the control group will receive standard care.

Active Comparator: Sildenafil

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

Interventions

Drug: - Sildenafil

Sildenafil in standard dosage

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.