Skip to main content
OpenTrials
Completed

NCT Number: NCT04283240

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

80 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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.

Treatment and study plan

Sildenafil

Drug

50 mg sildenafil, one dose

Placebo

Drug

Placebo

Primary outcomes

  1. Cardiac Index

    Time frame: 74 (plus/minus 17) minutes after drug administration

    Cardiac Index measured by cardiac magnetic resonance imaging

Other outcomes

  1. Right ventricular stroke volume

    Time frame: 74 (plus/minus 17) minutes after drug administration

    Evaluated by cardiac magnetic resonance imaging

  2. Cardiac output

    Time frame: 74 (plus/minus 17) minutes after drug administration

    Evaluated by cardiac magnetic resonance imaging

  3. Right ventricular end diastolic volume

    Time frame: 74 (plus/minus 17) minutes after drug administration

    Evaluated by cardiac magnetic resonance imaging

  4. Right ventricular end systolic volume

    Time frame: 74 (plus/minus 17) minutes after drug administration

    Evaluated by cardiac magnetic resonance imaging

  5. Right ventricular ejection fraction

    Time frame: 74 (plus/minus 17) minutes after drug administration

    Evaluated by cardiac magnetic resonance imaging

  6. Mean longitudinal strain

    Time frame: 74 (plus/minus 17) minutes after drug administration

    Evaluated by cardiac magnetic resonance imaging

  7. Mean pulmonary capillary wedge pressure

    Time frame: 32 (plus/minus 5 min) minutes after drug administration

    Evaluated by Right heart catheterization

  8. diastolic pulmonary artery pressure

    Time frame: 32 (plus/minus 5 min) minutes after drug administration

    Evaluated by Right heart catheterization

  9. systolic pulmonary artery pressure

    Time frame: 32 (plus/minus 5 min) minutes after drug administration

    Evaluated by Right heart catheterization

  10. mean pulmonary artery pressure

    Time frame: 32 (plus/minus 5 min) minutes after drug administration

    Evaluated by Right heart catheterization

  11. Pulmonary vascular resistance

    Time frame: 32 (plus/minus 5 min) minutes after drug administration

    Evaluated by Right heart catheterization

  12. Venous oxygen saturation

    Time frame: 32 (plus/minus 5 min) minutes after drug administration

    Evaluated by Right heart catheterization

  13. Right ventricular/left ventricular diameter

    Time frame: 84 (plus/minus 40) minutes after drug administration

    Evaluated by echocardiography

  14. Right ventricular fractional area change

    Time frame: 84 (plus/minus 40) minutes after drug administration

    Evaluated by echocardiography

  15. Tricuspid annular plane systolic excursion

    Time frame: 84 (plus/minus 40) minutes after drug administration

    Evaluated by echocardiography

  16. Pulmonary artery acceleration time

    Time frame: 84 (plus/minus 40) minutes after drug administration

    Evaluated by echocardiography

  17. Tricuspid regurgitant gradient

    Time frame: 84 (plus/minus 40) minutes after drug administration

    Evaluated by echocardiography

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Pulmonary Vasodilation by Sildenafil in Acute Pulmonary Embolism

Acronym: YGGDRASIL

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Feb 25, 2020
Registry last updated
Feb 25, 2020

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.

Published trials that share one or more normalized conditions with this study.