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OpenTrials
Completed

NCT Number: NCT04459364

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Attgeno AB

Industry

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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