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Prognostic Value of Estimated Plasma Volume in Pulmonary Hypertension

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT05861479
Collaborator
(none)
100
Enrollment
99
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Assessment of the prognostic value of the estimation of plasma volume or its variation in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) after acute right heart failure.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of the study is to show that a low plasma volume status, assessed by the Strauss (estimated plasma volume variation) and the Duarte (instantaneous estimated plasma volume) formulas evaluated during acute right heart failure in patients presenting with PAH or CTEPH, is associated with better long-term outcomes.

    Optimization of plasma volume is important for patients with PAH and CTEPH and constitutes a prognostic factor. However, plasma volume status can be difficult to assess in clinical practice. Different formulas have been developed and have shown interest in patients with congestive heart failure with an association between plasma volume estimation and long-term prognosis.

    Acute right heart failure may occur in patients with PAH and CTEPH. Thus, the investigators plan to study the prognostic value of these formulas evaluating plasma volume, in patients with PAH or CTEPH, after acute right heart failure.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Assessment of the Prognostic Value of the Estimation of Plasma Volume or Its Variation in Patients With Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) After Acute Right Heart Failure
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Jan 1, 2023
    Actual Study Completion Date :
    Apr 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Survival [From the first visit to 1st April 2023]

      Death

    2. Recurrence of acute right heart failure [From the first visit to 1st April 2023]

      Hospital admission for acute right heart failure

    3. Acute right heart failure-free survival [From the first visit to 1st April 2023]

      First event: death or hospital admission for acute right heart failure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients with confirmed diagnosis of PAH or CTEPH, referred to the medical department of the investigators

    2. Patient with acute right heart failure defined by at least 2 of the following clinical features: worsening of peripheral oedema, development or increase of ascites, weight gain of more than 2.5 kg in 1 week preceding the visit and decline in one NYHA functional class compared to the previous stable state

    Exclusion Criteria:
    1. Patients with another cause of pulmonary hypertension than PAH or CTEPH, either groups 2, 3 or 5 of the current clinical classification of pulmonary hypertension

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05861479
    Other Study ID Numbers:
    • 2022PI167
    First Posted:
    May 17, 2023
    Last Update Posted:
    May 17, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension, Pulmonary
    Pulmonary Arterial Hypertension
    Familial Primary Pulmonary Hypertension
    Hypertension
    Heart Failure

    Study Results

    No Results Posted as of May 17, 2023