NCT04283240

Brief Summary

To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2015

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

2.5 years

First QC Date

February 7, 2020

Last Update Submit

February 21, 2020

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • Cardiac Index

    Cardiac Index measured by cardiac magnetic resonance imaging

    74 (plus/minus 17) minutes after drug administration

Other Outcomes (17)

  • Right ventricular stroke volume

    74 (plus/minus 17) minutes after drug administration

  • Cardiac output

    74 (plus/minus 17) minutes after drug administration

  • Right ventricular end diastolic volume

    74 (plus/minus 17) minutes after drug administration

  • +14 more other outcomes

Study Arms (2)

Sildenafil

ACTIVE COMPARATOR

50 mg sildenafil oral. One dose

Drug: Sildenafil

Placebo

PLACEBO COMPARATOR

Placebo pill. One dose

Drug: Placebo

Interventions

SildenafilDRUG

50 mg sildenafil, one dose

Sildenafil
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age80 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 33639897DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Asger Andersen, MD,PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Treatment was blinded by the institutional pharmacy embedding the placebo or treatment pill in a gelatinous cap
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 25, 2020

Study Start

March 1, 2015

Primary Completion

September 10, 2017

Study Completion

September 10, 2018

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

By request

Locations

DK(1)