Sildenafil in Acute Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— YGGDRASIL  

Official title:

Pulmonary Vasodilation by Sildenafil in Acute Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04283240
• Other study ID #: 1-10-72-282-14
• Status: Completed
• Phase: Early Phase 1
• Start date: March 1, 2015
• Est. completion date: September 10, 2018

Study information

• Verified date: February 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 10, 2018
• Est. primary completion date: September 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• Sildenafil
50 mg sildenafil, one dose
• Placebo
Placebo

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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