Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP

Pulmonary Hypertension Clinical Trial

— OCT²EPH  

Official title:

Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844036
• Other study ID #: 38RC13.440
• Status: Completed
• Phase: N/A
• First received: July 15, 2016
• Last updated: October 20, 2017
• Start date: June 2014
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Procedure:
• Percutaneous angioplasty

• Balloon angioplasty

• Right heart catheterization

• Echocardiography

Other:
• A six-minute walking test

Procedure:
• Functional respiratory investigations

• Pulmonary tomography or pulmonary angiography

Other:
• Biological parameters

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (11)

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. — View Citation

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

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. — View Citation

Fukumoto Y, Shimokawa H. Recent progress in the management of pulmonary hypertension. Circ J. 2011;75(8):1801-10. Epub 2011 Jul 11. Review. — View Citation

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. — View Citation

Jaïs 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2011 Dec 15. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percutaneous angioplasty	International Normalized Ratio wil be measure and need to be between 2 and 3.	About 90 minutes
Primary	Balloon angioplasty	Same mode than valscular or coronal angioplasty.	About 90 minutes
Primary	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
Primary	Echocardiography	Right ventricular heart function with evaluation of : - The maximum pressure gradient (mmHg)	Few minutes
Primary	Walking test	Start heart rate (T0) and at the end (T6) of the test (bpm)	6 minutes
Primary	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
Primary	Pulmonary tomography or pulmonary angiography	tomography (CT) or angiography	About 30 minutes
Primary	Heart rate	Heart rate (bpm) during right heart catheterization.	Few minutes
Primary	Cardiac output (L/min)	Cardiac output (L/min) during right heart catheterization.	Few minutes
Primary	Venous oxygen saturation (%)	Venous oxygen saturation (%) during right heart catheterization.	Few minutes
Primary	Echocardiography	Right ventricular heart function with evaluation of : Surface area of the right ventricle (cm²)	Few minutes
Primary	Echocardiography	Right ventricular heart function with evaluation of : Cardiac output (L/min) and cardiac index (L/min/m²)	Few minutes
Primary	Walking test	Patient self evaluation of the dyspnea on a Borg scale from 0 (not breathless) to 10 (serious breathless)	6 minutes
Primary	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