Prognostic Value of Estimated Plasma Volume in Pulmonary Hypertension

Completed

• Conditions: Chronic Thromboembolic Pulmonary Hypertension; Acute Right Heart Failure; Pulmonary Arterial Hypertension

• Registration Number: NCT05861479
• Lead Sponsor: Central Hospital, Nancy, France

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.

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 Timeline

• Study Start: 2015-01-01
• Primary Completion: 2023-01-01
• Status Verified: 2023-04
• Study Completion: 2023-04-01
• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-05
• Last Update Submitted: 2023-05-05
• Study First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	From the first visit to 1st April 2023	Death
Recurrence of acute right heart failure	From the first visit to 1st April 2023	Hospital admission for acute right heart failure
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