Pulmonary EmbolismEarly Phase 1YGGDRASILNCT04283240
Sildenafil in Acute Pulmonary Embolism
A Early Phase 1 study testing Sildenafil in people with Pulmonary Embolism, run by University of Aarhus at 1 site in Denmark.
Trial summary
To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 80 to 80 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2015to 10 Sep 2018
- Phase
- Early Phase 1
- 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 80 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with acute pulmonary embolism confirmed by contrast enhanced computed tomography (CT)
- symptom duration of less than 14 days
- older than 18-80 years
- right ventricular/left ventricular ratio (RV/LV) >1 measured by trans-thoracic echocardiography (TTE, 1 cm above the atrio-ventricular valves in the four-chamber view at end-diastole).
Who cannot join
- pregnant
- cardiac arrest that required cardiopulmonary resuscitation
- a life expectancy <120 days
- systolic blood pressure <90 mmHg
- metal implants, obesity or claustrophobia that excluded the patient from cardiac magnetic resonance (CMR)
- altered mental status making the patient unable to provide informed consent
Show all 10Show fewer
- recent use of drugs with influence on the Nitric oxide-cyclic guanosine monophosphate pathway
- known or suspected chronic thromboembolic pulmonary hypertension
- inability to perform study protocol < 72 hours after conventional PE treatment was instituted
- active bleeding after thrombolysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Vasodilation by Sildenafil in Acute Pulmonary Embolism
To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).
Read the detailed description
Patients with PE randomized to a single oral dose of sildenafil 50mg (n=10) or placebo (n=10) as add-on to conventional therapy. Right ventricular function evaluated immediately before and shortly after (0.5-1.5h) randomization by right heart catheterization (RHC), trans-thoracic echocardiography (TTE), and cardiac magnetic resonance (CMR). The primary efficacy endpoint was cardiac index measured by CMR.
- Conditions
- Pulmonary Embolism
- Being tested
- Sildenafil, Placebo
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
50 mg sildenafil, one dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Active comparator | 50 mg sildenafil oral. One dose Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | Placebo pill. One dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Index
Cardiac Index measured by cardiac magnetic resonance imaging
Measured: 74 (plus/minus 17) minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Mar 2015
- Primary completion10 Sep 2017
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asger Andersen, MD,PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283240
- Sponsor's protocol ID
- 1-10-72-282-14
- Acronym
- YGGDRASIL
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: By request
Publications
Andersen A, Waziri F, Schultz JG, Holmboe S, Becker SW, Jensen T, Sondergaard HM, Dodt KK, May O, Mortensen UM, Kim WY, Mellemkjaer S, Nielsen-Kudsk JE. Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial. BMC Pulm Med. 2021 Feb 28;21(1):72. doi: 10.1186/s12890-021-01440-7.
PubMed 33639897
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vasodilation by Sildenafil in Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT04283240
- Acronym / sponsor ID
- YGGDRASIL / 1-10-72-282-14
- Conditions
- Pulmonary Embolism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 10 Sep 2017 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 25 Feb 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.
To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).
Detailed description
Patients with PE randomized to a single oral dose of sildenafil 50mg (n=10) or placebo (n=10) as add-on to conventional therapy. Right ventricular function evaluated immediately before and shortly after (0.5-1.5h) randomization by right heart catheterization (RHC), trans-thoracic echocardiography (TTE), and cardiac magnetic resonance (CMR). The primary efficacy endpoint was cardiac index measured by CMR.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Active comparator | Drug: Sildenafil50 mg sildenafil oral. One dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill. One dose |
Who may qualify
- Ages
- 80 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients with acute pulmonary embolism confirmed by contrast enhanced computed tomography (CT)
- symptom duration of less than 14 days
- older than 18-80 years
- right ventricular/left ventricular ratio (RV/LV) >1 measured by trans-thoracic echocardiography (TTE, 1 cm above the atrio-ventricular valves in the four-chamber view at end-diastole).
Key exclusion criteria (10 listed)
- pregnant
- cardiac arrest that required cardiopulmonary resuscitation
- a life expectancy <120 days
- systolic blood pressure <90 mmHg
- metal implants, obesity or claustrophobia that excluded the patient from cardiac magnetic resonance (CMR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil50 mg sildenafil, one dose | Drug | Sildenafil |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Cardiac Index
Time frame: 74 (plus/minus 17) minutes after drug administration
Cardiac Index measured by cardiac magnetic resonance imaging
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 25 Feb 2020.
- Derived from this study: PubMed 33639897Andersen A, Waziri F, Schultz JG, Holmboe S, Becker SW, Jensen T, Sondergaard HM, Dodt KK, May O, Mortensen UM, Kim WY, Mellemkjaer S, Nielsen-Kudsk JE. Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial. BMC Pulm Med. 2021 Feb 28;21(1):72. doi: 10.1186/s12890-021-01440-7.
- Individual participant dataSharing planned: No. By request
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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.
Asger Andersen, MD,PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sildenafil in people with Pulmonary Embolism, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 10 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 25 Feb 2020. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardiac Index (time frame: 74 (plus/minus 17) minutes after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283240, which also lists 1 linked publication.
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 25 Feb 2020.