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Completed

NCT Number: NCT02844036

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

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospitalGrenoble

La Tronche, 38700, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous angioplasty

Procedure

Balloon angioplasty

Procedure

Right heart catheterization

Procedure

Echocardiography

Procedure

A six-minute walking test

Other

Functional respiratory investigations

Procedure

Pulmonary tomography or pulmonary angiography

Procedure

biological parameters

Other

Primary outcomes

  1. Percutaneous angioplasty

    Time frame: About 90 minutes

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

  2. Balloon angioplasty

    Time frame: About 90 minutes

    Same mode than valscular or coronal angioplasty.

  3. Right heart catheterization

    Time frame: Few minutes

    Right auricular pressure auriculaire droite moyenne ou POD (mmHg)

    • Blood pressure : systolic, diastolic, and average(mmHg)
    • pression artérielle pulmonaire d'occlusion (PAPO) moyenne (mmHg)

  4. Echocardiography

    Time frame: Few minutes

    Right ventricular heart function with evaluation of :

    • The maximum pressure gradient (mmHg)

  5. Walking test

    Time frame: 6 minutes

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

  6. Functional respiratory investigations

    Time frame: About an hour

    • 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

  7. Pulmonary tomography or pulmonary angiography

    Time frame: About 30 minutes

    tomography (CT) or angiography

  8. Heart rate

    Time frame: Few minutes

    Heart rate (bpm) during right heart catheterization.

  9. Cardiac output (L/min)

    Time frame: Few minutes

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

  10. Venous oxygen saturation (%)

    Time frame: Few minutes

    Venous oxygen saturation (%) during right heart catheterization.

  11. Echocardiography

    Time frame: Few minutes

    Right ventricular heart function with evaluation of :

    Surface area of the right ventricle (cm²)

  12. Echocardiography

    Time frame: Few minutes

    Right ventricular heart function with evaluation of :

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

  13. Walking test

    Time frame: 6 minutes

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

  14. Walking test

    Time frame: 6 minutes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: OCT²EPH

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2016
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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