Sildenafil in Acute Pulmonary Embolism (YGGDRASIL)

February 21, 2020 updated by: University of Aarhus

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

80 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sildenafil
50 mg sildenafil oral. One dose
Drug: Sildenafil
50 mg sildenafil, one dose
Placebo Comparator: Placebo
Placebo pill. One dose
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiac Index
Time Frame: 74 (plus/minus 17) minutes after drug administration
Cardiac Index measured by cardiac magnetic resonance imaging
74 (plus/minus 17) minutes after drug administration

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Right ventricular stroke volume
Time Frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
74 (plus/minus 17) minutes after drug administration
Cardiac output
Time Frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
74 (plus/minus 17) minutes after drug administration
Right ventricular end diastolic volume
Time Frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
74 (plus/minus 17) minutes after drug administration
Right ventricular end systolic volume
Time Frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
74 (plus/minus 17) minutes after drug administration
Right ventricular ejection fraction
Time Frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
74 (plus/minus 17) minutes after drug administration
Mean longitudinal strain
Time Frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
74 (plus/minus 17) minutes after drug administration
Mean pulmonary capillary wedge pressure
Time Frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
32 (plus/minus 5 min) minutes after drug administration
diastolic pulmonary artery pressure
Time Frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
32 (plus/minus 5 min) minutes after drug administration
systolic pulmonary artery pressure
Time Frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
32 (plus/minus 5 min) minutes after drug administration
mean pulmonary artery pressure
Time Frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
32 (plus/minus 5 min) minutes after drug administration
Pulmonary vascular resistance
Time Frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
32 (plus/minus 5 min) minutes after drug administration
Venous oxygen saturation
Time Frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
32 (plus/minus 5 min) minutes after drug administration
Right ventricular/left ventricular diameter
Time Frame: 84 (plus/minus 40) minutes after drug administration
Evaluated by echocardiography
84 (plus/minus 40) minutes after drug administration
Right ventricular fractional area change
Time Frame: 84 (plus/minus 40) minutes after drug administration
Evaluated by echocardiography
84 (plus/minus 40) minutes after drug administration
Tricuspid annular plane systolic excursion
Time Frame: 84 (plus/minus 40) minutes after drug administration
Evaluated by echocardiography
84 (plus/minus 40) minutes after drug administration
Pulmonary artery acceleration time
Time Frame: 84 (plus/minus 40) minutes after drug administration
Evaluated by echocardiography
84 (plus/minus 40) minutes after drug administration
Tricuspid regurgitant gradient
Time Frame: 84 (plus/minus 40) minutes after drug administration
Evaluated by echocardiography
84 (plus/minus 40) minutes after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Asger Andersen, MD,PhD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-10-72-282-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

By request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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