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Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP (OCT²EPH)

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Percutaneous angioplasty
Balloon angioplasty
Right heart catheterization
Echocardiography
A six-minute walking test
Functional respiratory investigations
Pulmonary tomography or pulmonary angiography
Biological parameters
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Distal Lesions, Post-embolic HTP, Angioplasty

Eligibility Criteria

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

Inclusion Criteria:

  • Patients over 18 years
  • Patients with a pulmonary hypertension diagnosed by right catheterisation, with a mean arterial pressure >30 mmHg and arterial pulmonary resistance > 3 UW.
  • Patients with group 4 (Dana point) pulmonary hypertension, thromboembolic.
  • Chronic thrombosis visible to scanner, pulmonary IRM angiogram or to pulmonary angiogram.
  • Patient's file refused by the reference center multidisciplinary coordination meetings for surgical thromboendartériectomy or refusal from the patient to be operate.
  • Absence of counter-argument to the femoral venous or jugular way.
  • Normal kidney function or moderatly degraded (clearance>30 mL) or dialysed renal failure
  • Persons affiliated to national social security
  • Signed free consent by patients

Exclusion Criteria:

  • Pulmonary hypertension pos-embolic operated by thromboendarteriectomy
  • Pulmonary hypertension Group 1 of Dana Point, meaning idiopathic, familial, post-anorectics, associate with a congenital heart disease associated to a scleroderma, associated to a chronic hemolytic disease
  • Pulmonary hypertension Group 2 of Dana Point, associated with a left cardiovascular disease
  • Pulmonary hypertension Group 3 of Dana Point, associated to a respiratory disease
  • Pulmonary hypertension Group 5 of Dana Point, of unclear or multifactorial mechanism
  • Hypersensitivity to HEXABRIX, to iodinated contrast product or one of its components
  • Obvious thyrotoxicosis
  • Protected major persons
  • Pregnant or breastfeeding women
  • Persons deprived of liberty
  • Persons in emergency situations.
  • No consent signed or approoved
  • Persons no affiliated to national social security

Sites / Locations

  • UniversityHospitalGrenoble

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with a pulmonary hypertension

Arm Description

Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.

Outcomes

Primary Outcome Measures

Percutaneous angioplasty
International Normalized Ratio wil be measure and need to be between 2 and 3.
Balloon angioplasty
Same mode than valscular or coronal angioplasty.
Right heart catheterization
Right auricular pressure auriculaire droite moyenne ou POD (mmHg) Blood pressure : systolic, diastolic, and average(mmHg) pression artérielle pulmonaire d'occlusion (PAPO) moyenne (mmHg)
Echocardiography
Right ventricular heart function with evaluation of : - The maximum pressure gradient (mmHg)
Walking test
Start heart rate (T0) and at the end (T6) of the test (bpm)
Functional respiratory investigations
Forced expiratory volume (FEV) ml/kg Forced vital capacity (FVC) ml/kg Total lung capacity ml/kg Alveolar capillarytransfer of Carbon monoxide (CO) ml/kg Transfer coefficient of CO (KCO) ml/kg All volumes in ml/kg
Pulmonary tomography or pulmonary angiography
tomography (CT) or angiography
Heart rate
Heart rate (bpm) during right heart catheterization.
Cardiac output (L/min)
Cardiac output (L/min) during right heart catheterization.
Venous oxygen saturation (%)
Venous oxygen saturation (%) during right heart catheterization.
Echocardiography
Right ventricular heart function with evaluation of : Surface area of the right ventricle (cm²)
Echocardiography
Right ventricular heart function with evaluation of : Cardiac output (L/min) and cardiac index (L/min/m²)
Walking test
Patient self evaluation of the dyspnea on a Borg scale from 0 (not breathless) to 10 (serious breathless)
Walking test
Arterial blood saturation in oxygen measured by an oxymeter dat the beginning (T0) and at the end of the test (T6) (SO2)

Secondary Outcome Measures

Full Information

First Posted
July 15, 2016
Last Updated
October 20, 2017
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02844036
Brief Title
Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP
Acronym
OCT²EPH
Official Title
Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Currently, the standard treatment for proximal thromboses lesions responsible for post-embolic pulmonary hypertension, is the surgical thromboendarterectomy. When the ravages are judged too distal or the patient is judged inoperable for a curative surgical gesture, there is no evidence of any therapeutic option, exept for K anti-vitamins for recurrent embolism. Prognosis is then pejorative with a 60% mortality at 5 years. This study propose an alternative treatment for these patients in therapeutic "dead end". This is about applying arterial thrombosis technique to the pulmonary circulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Distal Lesions, Post-embolic HTP, Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with a pulmonary hypertension
Arm Type
Experimental
Arm Description
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous angioplasty
Intervention Type
Procedure
Intervention Name(s)
Balloon angioplasty
Intervention Type
Procedure
Intervention Name(s)
Right heart catheterization
Intervention Type
Procedure
Intervention Name(s)
Echocardiography
Intervention Type
Other
Intervention Name(s)
A six-minute walking test
Intervention Type
Procedure
Intervention Name(s)
Functional respiratory investigations
Intervention Type
Procedure
Intervention Name(s)
Pulmonary tomography or pulmonary angiography
Intervention Type
Other
Intervention Name(s)
Biological parameters
Primary Outcome Measure Information:
Title
Percutaneous angioplasty
Description
International Normalized Ratio wil be measure and need to be between 2 and 3.
Time Frame
About 90 minutes
Title
Balloon angioplasty
Description
Same mode than valscular or coronal angioplasty.
Time Frame
About 90 minutes
Title
Right heart catheterization
Description
Right auricular pressure auriculaire droite moyenne ou POD (mmHg) Blood pressure : systolic, diastolic, and average(mmHg) pression artérielle pulmonaire d'occlusion (PAPO) moyenne (mmHg)
Time Frame
Few minutes
Title
Echocardiography
Description
Right ventricular heart function with evaluation of : - The maximum pressure gradient (mmHg)
Time Frame
Few minutes
Title
Walking test
Description
Start heart rate (T0) and at the end (T6) of the test (bpm)
Time Frame
6 minutes
Title
Functional respiratory investigations
Description
Forced expiratory volume (FEV) ml/kg Forced vital capacity (FVC) ml/kg Total lung capacity ml/kg Alveolar capillarytransfer of Carbon monoxide (CO) ml/kg Transfer coefficient of CO (KCO) ml/kg All volumes in ml/kg
Time Frame
About an hour
Title
Pulmonary tomography or pulmonary angiography
Description
tomography (CT) or angiography
Time Frame
About 30 minutes
Title
Heart rate
Description
Heart rate (bpm) during right heart catheterization.
Time Frame
Few minutes
Title
Cardiac output (L/min)
Description
Cardiac output (L/min) during right heart catheterization.
Time Frame
Few minutes
Title
Venous oxygen saturation (%)
Description
Venous oxygen saturation (%) during right heart catheterization.
Time Frame
Few minutes
Title
Echocardiography
Description
Right ventricular heart function with evaluation of : Surface area of the right ventricle (cm²)
Time Frame
Few minutes
Title
Echocardiography
Description
Right ventricular heart function with evaluation of : Cardiac output (L/min) and cardiac index (L/min/m²)
Time Frame
Few minutes
Title
Walking test
Description
Patient self evaluation of the dyspnea on a Borg scale from 0 (not breathless) to 10 (serious breathless)
Time Frame
6 minutes
Title
Walking test
Description
Arterial blood saturation in oxygen measured by an oxymeter dat the beginning (T0) and at the end of the test (T6) (SO2)
Time Frame
6 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years Patients with a pulmonary hypertension diagnosed by right catheterisation, with a mean arterial pressure >30 mmHg and arterial pulmonary resistance > 3 UW. Patients with group 4 (Dana point) pulmonary hypertension, thromboembolic. Chronic thrombosis visible to scanner, pulmonary IRM angiogram or to pulmonary angiogram. Patient's file refused by the reference center multidisciplinary coordination meetings for surgical thromboendartériectomy or refusal from the patient to be operate. Absence of counter-argument to the femoral venous or jugular way. Normal kidney function or moderatly degraded (clearance>30 mL) or dialysed renal failure Persons affiliated to national social security Signed free consent by patients Exclusion Criteria: Pulmonary hypertension pos-embolic operated by thromboendarteriectomy Pulmonary hypertension Group 1 of Dana Point, meaning idiopathic, familial, post-anorectics, associate with a congenital heart disease associated to a scleroderma, associated to a chronic hemolytic disease Pulmonary hypertension Group 2 of Dana Point, associated with a left cardiovascular disease Pulmonary hypertension Group 3 of Dana Point, associated to a respiratory disease Pulmonary hypertension Group 5 of Dana Point, of unclear or multifactorial mechanism Hypersensitivity to HEXABRIX, to iodinated contrast product or one of its components Obvious thyrotoxicosis Protected major persons Pregnant or breastfeeding women Persons deprived of liberty Persons in emergency situations. No consent signed or approoved Persons no affiliated to national social security
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Bouvaist, Doctor
Organizational Affiliation
Grenoble Hospital University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversityHospitalGrenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23192917
Citation
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Citation
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Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP

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