Sildenafil in Acute Pulmonary Embolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2018-09-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sidlenafil in Combination With Oral Anticoagulants in Patients With Intermediate-high Risk of Pulmonary Embolism

NCT02946944

Pulmonary Embolism Intermediate-high Risk Combination of Oral Anticoagulation Therapy and Sildenafil

UNKNOWN PHASE1

Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery

NCT01481350

Pulmonary Hypertension

COMPLETED PHASE2

Hemodynamic Response After Six Months of Sildenafil

NCT00483626

Pulmonary Arterial Hypertension

UNKNOWN PHASE4

Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension

NCT00730067

COPD Pulmonary Hypertension

WITHDRAWN PHASE4

Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension

NCT01091012

Pulmonary Hypertension

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Embolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Treatment was blinded by the institutional pharmacy embedding the placebo or treatment pill in a gelatinous cap

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sildenafil

50 mg sildenafil oral. One dose

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

50 mg sildenafil, one dose

Placebo

Placebo pill. One dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sildenafil

50 mg sildenafil, one dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

80 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No