Acute Decompensation of Pulmonary Hypertension

NCT03926572 | Completed

• 1 other identifier: APHP180273
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Pulmonary; Biomarkers

Outcome Measures

Primary Outcomes (1)

• time to death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit

  The primary endpoint is a composite endpoint including death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit

  90 days

Secondary Outcomes (2)

• Survival time without graft or circulatory assistance

  1 month

• Survival time without transplantation or circulatory assitance

  12 months

Study Arms (1)

Patients with Pulmonary arterial hypertension

OTHER

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

Interventions

A biobank will be created from blood samples taken at admission, days 3 and days 7 OTHER

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)

Patients with Pulmonary arterial hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 18 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

SAVALE Laurent

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• SAVALE Laurent, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 24, 2019
• Study Start: September 19, 2019
• Primary Completion: December 12, 2022
• Study Completion: December 16, 2022
• Last Updated: October 26, 2024

Record last verified: 2024-09

Locations

FR (1)