Copd Exacerbation and Pulmonary Hypertension Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2024-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Exacerbation of COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a multicenter controlled, randomized, open-lapel trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Patients in the control group will receive standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Sildenafil

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

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

Sildenafil in standard dosage

Interventions

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Sildenafil

Sildenafil in standard dosage

Intervention Type DRUG

Other Intervention Names

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Vizarsin

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No