Hypertension, PulmonaryNCT04459364
The Prevalence of Pulmonary Hypertension in Patients With COVID-19.
An observational study of Hypertension, Pulmonary and Right Ventricular Overload, run by Attgeno AB at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary, Right Ventricular Overload, COVID
- How many people
- 67 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2020to 15 Jul 2020
- How long will I take part?
- 21 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Men and women at least 18 years of age
- Diagnosed with COVID-19 and is treated at an intensive care unit.
Who cannot join
- Responsible investigator considers that co-morbidity is so pronounced that it does not allow reasonable interpretation of data.
- Missing verified diagnosis of COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
Demographics and data from study variables will be documented in paper CRFs at the investigational site.
- Demography
- Age, sex
- Covid-19 related variables
- COVID-19 diagnosis
- Concomitant diseases
- Comorbidity, previous and present
- Cardiovascular risk factors
- Smoking
- Laboratory values
- On-site measurements o Evaluation with echocardiography
- Conditions
- Hypertension, Pulmonary, Right Ventricular Overload, COVID
- Medical subject headings
- Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jun 2020
- Primary completion7 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 67 participants (actual)
- Target duration
- 21 Days
Sponsor and investigators
- Lead sponsor
- Attgeno AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per-Arne Lönnqvist, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459364
- Sponsor's protocol ID
- 20200422PA
- Status last verified
- Jan 2021
- First submitted
- 3 Jul 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participants data that underlie the results reported in this article will be shared, after deidentification (text, figures and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04459364
- Acronym / sponsor ID
- 20200422PA
- Conditions
- Hypertension, Pulmonary, Right Ventricular Overload, COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Attgeno ABIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Age, sex
- Covid-19 related variables
- COVID-19 diagnosis
- Concomitant diseases
- Comorbidity, previous and present
- Cardiovascular risk factors
- Smoking
- Laboratory values
- On-site measurements o Evaluation with echocardiography
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 21 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Men and women at least 18 years of age
- Diagnosed with COVID-19 and is treated at an intensive care unit.
Key exclusion criteria (2 listed)
- Responsible investigator considers that co-morbidity is so pronounced that it does not allow reasonable interpretation of data.
- Missing verified diagnosis of COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Individual participant dataSharing planned: Yes. Individual participants data that underlie the results reported in this article will be shared, after deidentification (text, figures and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per-Arne Lönnqvist, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary and Right Ventricular Overload, run by Attgeno AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.