Sildenafil in Acute Pulmonary Embolism

Early Phase 1CompletedNCT04283240

University of Aarhus20 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Pulmonary Embolism

Interventions

SildenafilDRUG

50 mg sildenafil, one dose

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 80 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

Cardiac Index

Cardiac Index measured by cardiac magnetic resonance imaging

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

Data from ClinicalTrials.gov

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