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PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

NCT02378649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-06-26

No results posted yet for this study

Summary

A randomized, placebo controlled, single center clinical trial for evaluation of efficacy and safety of Sildenafil administration in the cardiac ICU following Mitral Valve (MV) Surgery in patients with pre-operative Significant Pulmonary Hypertension.

Conditions

  • Pulmonary Hypertension
  • Mitral Valve Surgery

Interventions

DRUG

Sildenafil

Sildenafil administration in the cardiac ICU following Mitral Valve Surgery concomitant with best practice usual care

DRUG

Placebo

Placebo comparator concomitant with best practice usual care

Sponsors & Collaborators

  • Dr. Robert Klempfner Heart Rehabilitation Institute

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02378649 on ClinicalTrials.gov