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

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.

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This is a non-interventional retrospective study to be performed in an intensive care unit in Sweden. The study will include 80 Covid-19 patients who had been examined with echocardiography. Data will be collected through chart review.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Attgeno AB
• Investigators: Principal Investigator: Per-Arne Lönnqvist, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): July 7, 2020
• Study Completion (ACTUAL): July 15, 2020

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 20200422PA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participants data that underlie the results reported in this article will be shared, after deidentification (text, figures and appendices)
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal and to achieve aims in the proposal. Proposals should be directed to per-arne.lonnqvist@ki.se. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No