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Completed

NCT Number: NCT05861479

Prognostic Value of Estimated Plasma Volume in Pulmonary Hypertension

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

  • 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

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: From the first visit to 1st April 2023

    Death

  2. Recurrence of acute right heart failure

    Time frame: From the first visit to 1st April 2023

    Hospital admission for acute right heart failure

  3. Acute right heart failure-free survival

    Time frame: From the first visit to 1st April 2023

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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
May 17, 2023
Registry last updated
May 17, 2023

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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