CompletedNCT04283240YGGDRASILUpdated Feb 25, 2020

Sildenafil in Acute Pulmonary Embolism

An Early Phase 1 interventional study of Sildenafil and Placebo in Pulmonary Embolism, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 80 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by University of Aarhus · Early Phase 1, Interventional, and Basic science

From the registry’s dates

Registered 4 years 11 months after the study started (first participant enrolled Mar 2015, registered Feb 2020).

Phase: Early Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 80 Years to 80 Years
Sex: All

Study summary

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 studied

Pulmonary Embolism

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In context

Pulmonary Embolism

738 studies on the registry are indexed under Pulmonary Embolism; 158 are open to participants now.

This study's enrollment of 20 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 80 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

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
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.

Study design

Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 20 participants (actual)

Study arms

Active comparator
Sildenafil
50 mg sildenafil oral. One dose
Drug: Sildenafil
Placebo comparator
Placebo
Placebo pill. One dose
Drug: Placebo

Interventions

DrugSildenafil
50 mg sildenafil, one dose
DrugPlacebo
Placebo

What researchers measure

Primary outcomes

Cardiac Index
Cardiac Index measured by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration

Other outcomes

Right ventricular stroke volume
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Cardiac output
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Right ventricular end diastolic volume
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Right ventricular end systolic volume
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Right ventricular ejection fraction
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Mean longitudinal strain
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Mean pulmonary capillary wedge pressure
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
diastolic pulmonary artery pressure
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
systolic pulmonary artery pressure
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
mean pulmonary artery pressure
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
Pulmonary vascular resistance
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
Venous oxygen saturation
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
Right ventricular/left ventricular diameter
Evaluated by echocardiography
Time frame: 84 (plus/minus 40) minutes after drug administration
Right ventricular fractional area change
Evaluated by echocardiography
Time frame: 84 (plus/minus 40) minutes after drug administration
Tricuspid annular plane systolic excursion
Evaluated by echocardiography
Time frame: 84 (plus/minus 40) minutes after drug administration
Pulmonary artery acceleration time
Evaluated by echocardiography
Time frame: 84 (plus/minus 40) minutes after drug administration
Tricuspid regurgitant gradient
Evaluated by echocardiography
Time frame: 84 (plus/minus 40) minutes after drug administration

Study locations

1 site

Aarhus University Hospital
Aarhus, 8200, Denmark

References and documents

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 ↗

Individual participant data

Plan to share: No — By request

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04283240
Lead sponsor: University of Aarhus
Responsible party: Sponsor
First posted: Feb 25, 2020
Start date: Mar 1, 2015
Primary completion: Sep 10, 2017
Completion: Sep 10, 2018
Last update: Feb 25, 2020

Study contacts

Asger Andersen, MD,PhD

principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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