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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Procedure: Echocardiography; Procedure: Percutaneous angioplasty; Procedure: Balloon angioplasty; Procedure: Right heart catheterization; Other: A six-minute walking test; Procedure: Functional respiratory investigations; Procedure: Pulmonary tomography or pulmonary angiography; Other: Biological parameters

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Tronche, France, 38700
    • UniversityHospitalGrenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with a pulmonary hypertension; Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.	Procedure: Echocardiography; Procedure: Percutaneous angioplasty; Procedure: Balloon angioplasty; Procedure: Right heart catheterization; Other: A six-minute walking test; Procedure: Functional respiratory investigations; Procedure: Pulmonary tomography or pulmonary angiography; Other: Biological parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Hélène Bouvaist, Doctor, Grenoble Hospital University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Diggle PJ, Liang KY, Zeger SL. Analysis of longitudinal data. New York: Oxfiord University Press, 2000.
• Twisk JWR. Applied longitudinal analysis for epidemiology. Cambridge: Cambridge University Press, 2003.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Angioplasty; Distal Lesions; Post-embolic HTP
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 38RC13.440