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Pulmonary HypertensionOCT²EPHNCT02844036

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

A study testing Percutaneous angioplasty, Balloon angioplasty and Right heart catheterization in people with Pulmonary Hypertension, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Hypertension
What is being tested?
Percutaneous angioplasty, Balloon angioplasty and Right heart catheterization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteFrance
Study dates
Jun 2014to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • Normal kidney function or moderatly degraded (clearance>30 mL) or dialysed renal failure
  • Persons affiliated to national social security
  • Signed free consent by patients

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • UniversityHospitalGrenoble

    La Tronche, 38700

Other trials in France

About this study

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.

Being tested
Percutaneous angioplasty, Balloon angioplasty, Right heart catheterization, Echocardiography, A six-minute walking test
Keywords
Distal Lesions, Post-embolic HTP, Angioplasty
Medical subject headings
Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous angioplastyProcedure or surgery

  • Balloon angioplastyProcedure or surgery

  • Right heart catheterizationProcedure or surgery

  • EchocardiographyProcedure or surgery

  • A six-minute walking testOther

  • Functional respiratory investigationsProcedure or surgery

  • Pulmonary tomography or pulmonary angiographyProcedure or surgery

  • Biological parametersOther

Study groups in NCT02844036
Study groupRoleWhat they receive
Patients with a pulmonary hypertensionExperimentalPulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
Receives: Procedure: Percutaneous angioplasty; Procedure: Balloon angioplasty; Procedure: Right heart catheterization; Procedure: Echocardiography; Other: A six-minute walking test; Procedure: Functional respiratory investigations; Procedure: Pulmonary tomography or pulmonary angiography; Other: Biological parameters

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percutaneous angioplasty

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

    Measured: About 90 minutes

  2. Balloon angioplasty

    Same mode than valscular or coronal angioplasty.

    Measured: About 90 minutes

  3. 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)

    Measured: Few minutes

  4. Echocardiography

    Right ventricular heart function with evaluation of :

    • The maximum pressure gradient (mmHg)

    Measured: Few minutes

  5. Walking test

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

    Measured: 6 minutes

  6. 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

    Measured: About an hour

  7. Pulmonary tomography or pulmonary angiography

    tomography (CT) or angiography

    Measured: About 30 minutes

  8. Heart rate

    Heart rate (bpm) during right heart catheterization.

    Measured: Few minutes

  9. Cardiac output (L/min)

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

    Measured: Few minutes

  10. Venous oxygen saturation (%)

    Venous oxygen saturation (%) during right heart catheterization.

    Measured: Few minutes

  11. Echocardiography

    Right ventricular heart function with evaluation of :

    Surface area of the right ventricle (cm²)

    Measured: Few minutes

  12. Echocardiography

    Right ventricular heart function with evaluation of :

    Cardiac output (L/min) and cardiac index (L/min/m²)

    Measured: Few minutes

  13. Walking test

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

    Measured: 6 minutes

  14. Walking test

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

    Measured: 6 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2016 (estimated)
  2. Study startJun 2014
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02844036
Sponsor's protocol ID
38RC13.440
Acronym
OCT²EPH
Status last verified
Oct 2017
First submitted
15 Jul 2016
Last updated
23 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23192917

  • 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.

    PubMed 22185711

  • 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.

    PubMed 21747194

  • 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.

    PubMed 11136677

  • 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.

    PubMed 19095129

  • 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.

  • 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.

    PubMed 21335128

  • 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.

    PubMed 23397304

  • 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.

    PubMed 22018451

  • 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.

    PubMed 23769649

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous angioplasty, Balloon angioplasty and Right heart catheterization in people with Pulmonary Hypertension, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percutaneous angioplasty (time frame: About 90 minutes). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02844036, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2017.

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