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

Completed

• Conditions: COVID; Hypertension, Pulmonary; Right Ventricular Overload

• Registration Number: NCT04459364
• Lead Sponsor: Attgeno AB

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-03
• Primary Completion: 2020-07-07
• Study First Posted: 2020-07-07
• Study Completion: 2020-07-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence	Day 1	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.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden