NCT02844036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

3.3 years

First QC Date

July 15, 2016

Last Update Submit

October 20, 2017

Conditions

Pulmonary Hypertension

Keywords

Distal LesionsPost-embolic HTPAngioplasty

Outcome Measures

Primary Outcomes (14)

  • Percutaneous angioplasty

    International Normalized Ratio wil be measure and need to be between 2 and 3.

    About 90 minutes

  • Balloon angioplasty

    Same mode than valscular or coronal angioplasty.

    About 90 minutes

  • 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)

    Few minutes

  • Echocardiography

    Right ventricular heart function with evaluation of : \- The maximum pressure gradient (mmHg)

    Few minutes

  • Walking test

    Start heart rate (T0) and at the end (T6) of the test (bpm)

    6 minutes

  • 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

    About an hour

  • Pulmonary tomography or pulmonary angiography

    tomography (CT) or angiography

    About 30 minutes

  • Heart rate

    Heart rate (bpm) during right heart catheterization.

    Few minutes

  • Cardiac output (L/min)

    Cardiac output (L/min) during right heart catheterization.

    Few minutes

  • Venous oxygen saturation (%)

    Venous oxygen saturation (%) during right heart catheterization.

    Few minutes

  • Echocardiography

    Right ventricular heart function with evaluation of : Surface area of the right ventricle (cm²)

    Few minutes

  • Echocardiography

    Right ventricular heart function with evaluation of : Cardiac output (L/min) and cardiac index (L/min/m²)

    Few minutes

  • Walking test

    Patient self evaluation of the dyspnea on a Borg scale from 0 (not breathless) to 10 (serious breathless)

    6 minutes

  • Walking test

    Arterial blood saturation in oxygen measured by an oxymeter dat the beginning (T0) and at the end of the test (T6) (SO2)

    6 minutes

Study Arms (1)

Patients with a pulmonary hypertension

EXPERIMENTAL

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

Procedure: Percutaneous angioplastyProcedure: Balloon angioplastyProcedure: Right heart catheterizationProcedure: EchocardiographyOther: A six-minute walking testProcedure: Functional respiratory investigationsProcedure: Pulmonary tomography or pulmonary angiographyOther: Biological parameters

Interventions

Percutaneous angioplastyPROCEDURE
Patients with a pulmonary hypertension
Balloon angioplastyPROCEDURE
Patients with a pulmonary hypertension
Right heart catheterizationPROCEDURE
Patients with a pulmonary hypertension
EchocardiographyPROCEDURE
Patients with a pulmonary hypertension
A six-minute walking testOTHER
Patients with a pulmonary hypertension
Functional respiratory investigationsPROCEDURE
Patients with a pulmonary hypertension
Pulmonary tomography or pulmonary angiographyPROCEDURE
Patients with a pulmonary hypertension
Biological parametersOTHER
Patients with a pulmonary hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversityHospitalGrenoble

La Tronche, 38700, France

Location

Related Publications (11)

  • Mizoguchi H, Ogawa A, Munemasa M, Mikouchi H, Ito H, Matsubara H. Refined balloon pulmonary angioplasty for inoperable patients with chronic thromboembolic pulmonary hypertension. Circ Cardiovasc Interv. 2012 Dec;5(6):748-55. doi: 10.1161/CIRCINTERVENTIONS.112.971077. Epub 2012 Nov 27.

    PMID: 23192917BACKGROUND

  • Sugimura K, Fukumoto Y, Satoh K, Nochioka K, Miura Y, Aoki T, Tatebe S, Miyamichi-Yamamoto S, Shimokawa H. Percutaneous transluminal pulmonary angioplasty markedly improves pulmonary hemodynamics and long-term prognosis in patients with chronic thromboembolic pulmonary hypertension. Circ J. 2012;76(2):485-8. doi: 10.1253/circj.cj-11-1217. Epub 2011 Dec 15.

    PMID: 22185711BACKGROUND

  • Fukumoto Y, Shimokawa H. Recent progress in the management of pulmonary hypertension. Circ J. 2011;75(8):1801-10. doi: 10.1253/circj.cj-11-0567. Epub 2011 Jul 11.

    PMID: 21747194BACKGROUND

  • Feinstein JA, Goldhaber SZ, Lock JE, Ferndandes SM, Landzberg MJ. Balloon pulmonary angioplasty for treatment of chronic thromboembolic pulmonary hypertension. Circulation. 2001 Jan 2;103(1):10-3. doi: 10.1161/01.cir.103.1.10.

    PMID: 11136677BACKGROUND

  • Jais X, D'Armini AM, Jansa P, Torbicki A, Delcroix M, Ghofrani HA, Hoeper MM, Lang IM, Mayer E, Pepke-Zaba J, Perchenet L, Morganti A, Simonneau G, Rubin LJ; Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension Study Group. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2127-34. doi: 10.1016/j.jacc.2008.08.059.

    PMID: 19095129BACKGROUND

  • Diggle PJ, Liang KY, Zeger SL. Analysis of longitudinal data. New York: Oxfiord University Press, 2000.

    BACKGROUND

  • Twisk JWR. Applied longitudinal analysis for epidemiology. Cambridge: Cambridge University Press, 2003.

    BACKGROUND

  • Mayer E, Jenkins D, Lindner J, D'Armini A, Kloek J, Meyns B, Ilkjaer LB, Klepetko W, Delcroix M, Lang I, Pepke-Zaba J, Simonneau G, Dartevelle P. Surgical management and outcome of patients with chronic thromboembolic pulmonary hypertension: results from an international prospective registry. J Thorac Cardiovasc Surg. 2011 Mar;141(3):702-10. doi: 10.1016/j.jtcvs.2010.11.024.

    PMID: 21335128BACKGROUND

  • Pepke-Zaba J, Jansa P, Kim NH, Naeije R, Simonneau G. Chronic thromboembolic pulmonary hypertension: role of medical therapy. Eur Respir J. 2013 Apr;41(4):985-90. doi: 10.1183/09031936.00201612. Epub 2013 Feb 8.

    PMID: 23397304BACKGROUND

  • de Perrot M, McRae K, Shargall Y, Pletsch L, Tan K, Slinger P, Ma M, Paul N, Moric J, Thenganatt J, Mak S, Granton JT. Pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension: the Toronto experience. Can J Cardiol. 2011 Nov-Dec;27(6):692-7. doi: 10.1016/j.cjca.2011.09.009. Epub 2011 Oct 21.

    PMID: 22018451BACKGROUND

  • Inami T, Kataoka M, Shimura N, Ishiguro H, Yanagisawa R, Taguchi H, Fukuda K, Yoshino H, Satoh T. Pulmonary edema predictive scoring index (PEPSI), a new index to predict risk of reperfusion pulmonary edema and improvement of hemodynamics in percutaneous transluminal pulmonary angioplasty. JACC Cardiovasc Interv. 2013 Jul;6(7):725-36. doi: 10.1016/j.jcin.2013.03.009. Epub 2013 Jun 14.

    PMID: 23769649BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Hélène Bouvaist, Doctor

    Grenoble Hospital University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 26, 2016

Study Start

June 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 23, 2017

Record last verified: 2017-10

Locations

FR(1)