An interventional study of Percutaneous angioplasty and Balloon angioplasty in Pulmonary Hypertension, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-23.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 33 is close to the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic.
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
Percutaneous angioplasty
International Normalized Ratio wil be measure and need to be between 2 and 3.
Time frame: About 90 minutes
Balloon angioplasty
Same mode than valscular or coronal angioplasty.
Time frame: 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)
Time frame: Few minutes
Echocardiography
Right ventricular heart function with evaluation of : - The maximum pressure gradient (mmHg)
Time frame: Few minutes
Walking test
Start heart rate (T0) and at the end (T6) of the test (bpm)
Time frame: 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
Time frame: About an hour
Pulmonary tomography or pulmonary angiography
tomography (CT) or angiography
Time frame: About 30 minutes
Heart rate
Heart rate (bpm) during right heart catheterization.
Time frame: Few minutes
Cardiac output (L/min)
Cardiac output (L/min) during right heart catheterization.
Time frame: Few minutes
Venous oxygen saturation (%)
Venous oxygen saturation (%) during right heart catheterization.
Time frame: Few minutes
Echocardiography
Right ventricular heart function with evaluation of : Surface area of the right ventricle (cm²)
Time frame: Few minutes
Echocardiography
Right ventricular heart function with evaluation of : Cardiac output (L/min) and cardiac index (L/min/m²)
Time frame: Few minutes
Walking test
Patient self evaluation of the dyspnea on a Borg scale from 0 (not breathless) to 10 (serious breathless)
Time frame: 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)
Time frame: 6 minutes
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble