The Prevalence of Pulmonary Hypertension in Patients With COVID-19.

COVID Clinical Trial

Official title:

The Prevalence of Pulmonary Hypertension, With or Without Right Ventricular Loading, in Patients With COVID-19 Who Are Being Treated With a Respirator in the Intensive Care Unit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459364
• Other study ID #: 20200422PA
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: January 2021
• Source: Attgeno AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The virus infection Covid-19 fills our hospitals and intensive care departments in a very unique way and there is a lack of essential insight into the pathophysiology of the disease. As a result, very specific treatment options are missing. The US Medicines Agency (FDA) has in the last days given a general license for treatment with inhaled nitric oxide (iNO). Inhaled NO in Sweden (and Europe) is approved for the indication of pulmonary hypertension in adults.

However, no one has yet described the occurrence of pulmonary hypertension, with or without right ventricular loading, in the Covid-19 patients who become so seriously ill that they need to be treated at an IVA ward. Knowledge of this is, of course, a prerequisite for determining the need for pulmonary artery catheterization (PA catheter, Swan-Ganz catheter) and also to better understand whether iNO treatment or other forms of lung selective vasodilation therapy may be of benefit to this patient group.

Description:

Demographics and data from study variables will be documented in paper CRFs at the investigational site.

• Demography

o Age, sex

• Covid-19 related variables

o COVID-19 diagnosis

• Concomitant diseases

o Comorbidity, previous and present

• Cardiovascular risk factors

o Smoking

• Laboratory values

• On-site measurements o Evaluation with echocardiography

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 15, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women at least 18 years of age

• Diagnosed with COVID-19 and is treated at an intensive care unit.

Exclusion Criteria:

• Responsible investigator considers that co-morbidity is so pronounced that it does not allow reasonable interpretation of data.

• Missing verified diagnosis of COVID-19

Related Conditions & MeSH terms

• COVID
• Hypertension
• Hypertension, Pulmonary
• Right Ventricular Overload

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Attgeno AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence	To determine the prevalence of pulmonary hypertension and right ventricular load in patients with COVID-19 treated in intensive care unit evaluated by routine echocardiography.	Day 1