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

NCT04459364 | Completed

• 1 other identifier: 20200422PA
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Pulmonary; Right Ventricular Overload; COVID

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Men and women at least 18 years of age
• Diagnosed with COVID-19 and is treated at an intensive care unit.

You may not qualify if:

• Responsible investigator considers that co-morbidity is so pronounced that it does not allow reasonable interpretation of data.
• Missing verified diagnosis of COVID-19

Sponsors & Collaborators

• Attgeno AB: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Per-Arne Lönnqvist, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 21 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 7, 2020
• Study Start: June 1, 2020
• Primary Completion: July 7, 2020
• Study Completion: July 15, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.

Locations

SE (1)