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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

Acute Decompensation of Pulmonary Hypertension

Clinicaltrials.gov identifier NCT03926572

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted July 2, 2020

Study Description

Brief summary:

The main objective of this study is to analyze the survival of a cohort of patients admitted for acute decompensation of pulmonary arterial hypertension or postembolic pulmonary hypertension and to establish the prognostic value of biomarkers.

  • Condition or Disease:Hypertension, Pulmonary
    Biomarkers
  • Intervention/Treatment: Other: A biobank will be created from blood samples taken at admission, days 3 and days 7
  • Phase: N/A
Detailed Description

It is planned to include 150 patients over a two-year period. The primary endpoint is a composite endpoint including death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit. Patients will be treated according to the usual practice. A biobank will be created from blood samples taken at admission, days 3 and days 7. Prognostic value of pre-selected biomarkers will be analyzed and a proteomic analysis will be performed in order to identify new biomarkers. The prognostic value of these new biological parameters will be compared to the usual monitoring parameters that will be collected during follow-up (clinical, echocardiographic and haemodynamic parameters). In a second step, it will establish, using a dynamic model, the best combinations of parameters allowing to best assessment of prognosis of patients suffering from PH and hospitalized for acute right ventricular failure.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: patients admitted for acute decompensation of pulmonary arterial hypertension or postembolic pulmonary hypertension with samples of blood samples taken at admission, days 3 and 7 in the context of this clinical study
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Other: Patients with Pulmonary arterial hypertension
Pulmonary arterial hypertension or non-operable chronic thromboembolic pulmonary hypertension established by right cardiac catheterization prior to inclusion in the study
Other: A biobank will be created from blood samples taken at admission, days 3 and days 7
A biobank will be created from the blood samples taken on admission, days 3 and 7 of admission. The prognostic value of the preselected biomarkers will be analyzed and a proteomic analysis will be performed to identify new biomarkers. The prognostic value of these new biological parameters will be compared to the usual surveillance parameters that will be collected during the follow-up (clinical, echocardiographic and hemodynamic parameters)
Outcome Measures
  • Primary Outcome Measures: 1. time to death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit [ Time Frame: 90 days ]
    The primary endpoint is a composite endpoint including death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit
  • Secondary Outcome Measures: 1. Survival time without graft or circulatory assistance [ Time Frame: 1 month ]
    Survival without transplantation or circulatory assitance at 1 month
  • 2. Survival time without transplantation or circulatory assitance [ Time Frame: 12 months ]
    Survival ithout transplantation or circulatory assitance at 12 month
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Adult patients over 18 years

- Diagnosis of Pulmonary arterial hypertension or non-operable chronic thromboembolic
pulmonary hypertension established by right cardiac catheterization prior to inclusion
in the study

- Patients admitted in intensive care unit for acute decompensation of pulmonary
hypertension requiring intravenous diuretic therapy ± use of inotropes or
vasopressors.

- Patients must have given their written informed consent to participate in the study
after having received adequate previous information and prior to any study-specific
procedures

Exclusion Criteria:

- Patients with post-capillary pulmonary hypertension

- Patients with pulmonary hypertension associated with chronic respiratory disease

- Patients with pulmonary hypertension with unclear/or multifactorial mechanisms

- Patients with operable chronic thromboembolic pulmonary hypertension

- Shock due to another cause than acute decompensation of pulmonary hypertension

- Pregnant women, or breast feeding women

- Adult protected person

- Person deprived of liberty

- Person admitted without consent

- Pregnant or breastfeeding women

Contacts and Locations
Contacts

Contact: SAVALE Laurent, MD, PhD 01 45 21 79 74 laurent.savale@aphp.fr

Locations

France
SAVALE Laurent
Le Kremlin-Bicêtre

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Study Chair: SAVALE Laurent, MD, PhD Assistance Publique - Hôpitaux de Paris

More Information
  • Responsible Party: Assistance Publique - Hôpitaux de Paris
  • ClinicalTrials.gov Identifier: NCT03926572 History of Changes
  • Other Study ID Numbers: APHP180273
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: July 2, 2020
  • Last Verified: July 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Hypertension, Pulmonary Hypertension