Pulmonary Embolism
Conditions
Brief summary
To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).
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.
Interventions
DRUGSildenafil
50 mg sildenafil, one dose
DRUGPlacebo
Placebo
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Treatment was blinded by the institutional pharmacy embedding the placebo or treatment pill in a gelatinous cap
Eligibility
Sex/Gender
ALL
Age
80 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Index | 74 (plus/minus 17) minutes after drug administration | Cardiac Index measured by cardiac magnetic resonance imaging |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiac output | 74 (plus/minus 17) minutes after drug administration | Evaluated by cardiac magnetic resonance imaging |
| Right ventricular end diastolic volume | 74 (plus/minus 17) minutes after drug administration | Evaluated by cardiac magnetic resonance imaging |
| Right ventricular end systolic volume | 74 (plus/minus 17) minutes after drug administration | Evaluated by cardiac magnetic resonance imaging |
| Right ventricular ejection fraction | 74 (plus/minus 17) minutes after drug administration | Evaluated by cardiac magnetic resonance imaging |
| Mean longitudinal strain | 74 (plus/minus 17) minutes after drug administration | Evaluated by cardiac magnetic resonance imaging |
| Mean pulmonary capillary wedge pressure | 32 (plus/minus 5 min) minutes after drug administration | Evaluated by Right heart catheterization |
| diastolic pulmonary artery pressure | 32 (plus/minus 5 min) minutes after drug administration | Evaluated by Right heart catheterization |
| systolic pulmonary artery pressure | 32 (plus/minus 5 min) minutes after drug administration | Evaluated by Right heart catheterization |
| Right ventricular stroke volume | 74 (plus/minus 17) minutes after drug administration | Evaluated by cardiac magnetic resonance imaging |
| Pulmonary vascular resistance | 32 (plus/minus 5 min) minutes after drug administration | Evaluated by Right heart catheterization |
| Venous oxygen saturation | 32 (plus/minus 5 min) minutes after drug administration | Evaluated by Right heart catheterization |
| Right ventricular/left ventricular diameter | 84 (plus/minus 40) minutes after drug administration | Evaluated by echocardiography |
| Right ventricular fractional area change | 84 (plus/minus 40) minutes after drug administration | Evaluated by echocardiography |
| Tricuspid annular plane systolic excursion | 84 (plus/minus 40) minutes after drug administration | Evaluated by echocardiography |
| Pulmonary artery acceleration time | 84 (plus/minus 40) minutes after drug administration | Evaluated by echocardiography |
| Tricuspid regurgitant gradient | 84 (plus/minus 40) minutes after drug administration | Evaluated by echocardiography |
| mean pulmonary artery pressure | 32 (plus/minus 5 min) minutes after drug administration | Evaluated by Right heart catheterization |
Countries
Denmark
Outcome results
None listed