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Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension

Primary Purpose

Residual Pulmonary Hypertension

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Ventavis
Warfarin
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Residual Pulmonary Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with pulmonary embolism after undergone surgical treatment (intravascular thrombolysis, catheter thrombus fragmentation)
  • Patients with preserved thromboembolism in the pulmonary circulation system and mean pressure in the pulmonary artery of more than 25 mm Hg

Exclusion Criteria:

  • Patient did not sign the informed consent.
  • Mean pulmonary artery pressure after surgical treatment less than 25 mm Hg
  • Age above 75 years.
  • Patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal ulcer in acute, hemorrhagic stroke.
  • Severe coronary artery disease (unstable angina, myocardial infarction within the last 6 months).
  • Acute heart failure or CHF IV in NYHA.
  • Severe arrhythmias.
  • Pregnancy, lactation.
  • The presence of severe diseases of other organ systems that may result in death during the first year after surgery.

Sites / Locations

  • State Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ventavis + Warfarin

Warfarin

Arm Description

Patients in this group will receive drug treatment - ventavis (2,0 ml - 6 time per day - during 5 days). Warfarin - INR=2,0-3,0

Patients in this group will receive drug treatment according to up-to-date guidelines (Warfarin - INR=2,0-3,0)

Outcomes

Primary Outcome Measures

Pulmonary hypertension
The average pressure in the pulmonary artery trunk (according to direct tensiometry before Ventavis therapy, after the therapy according to transthoracic echocardiography and six months after discharge (transthoracic echocardiography).

Secondary Outcome Measures

Number of deaths
Number of recurrent pulmonary embolisms
Number of venous thromboembolisms

Full Information

First Posted
September 3, 2014
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02238535
Brief Title
Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
Official Title
Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual pulmonary hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Residual Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ventavis + Warfarin
Arm Type
Active Comparator
Arm Description
Patients in this group will receive drug treatment - ventavis (2,0 ml - 6 time per day - during 5 days). Warfarin - INR=2,0-3,0
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Patients in this group will receive drug treatment according to up-to-date guidelines (Warfarin - INR=2,0-3,0)
Intervention Type
Drug
Intervention Name(s)
Ventavis
Intervention Type
Drug
Intervention Name(s)
Warfarin
Primary Outcome Measure Information:
Title
Pulmonary hypertension
Description
The average pressure in the pulmonary artery trunk (according to direct tensiometry before Ventavis therapy, after the therapy according to transthoracic echocardiography and six months after discharge (transthoracic echocardiography).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of deaths
Time Frame
6 months
Title
Number of recurrent pulmonary embolisms
Time Frame
6 months
Title
Number of venous thromboembolisms
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with pulmonary embolism after undergone surgical treatment (intravascular thrombolysis, catheter thrombus fragmentation) Patients with preserved thromboembolism in the pulmonary circulation system and mean pressure in the pulmonary artery of more than 25 mm Hg Exclusion Criteria: Patient did not sign the informed consent. Mean pulmonary artery pressure after surgical treatment less than 25 mm Hg Age above 75 years. Patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal ulcer in acute, hemorrhagic stroke. Severe coronary artery disease (unstable angina, myocardial infarction within the last 6 months). Acute heart failure or CHF IV in NYHA. Severe arrhythmias. Pregnancy, lactation. The presence of severe diseases of other organ systems that may result in death during the first year after surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yulia Klevanets, MD
Phone
+79139443607
Email
klevanetc@yandex.ru
Facility Information:
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yulia Klevanets, MD
Phone
+79139443607
Email
klevanetc@yandex.ru

12. IPD Sharing Statement

Links:
URL
http://meshalkin.ru
Description
Related Info

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Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension

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