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NCT05861479 Clinical Trial

Prognostic Value of Estimated Plasma Volume in Pulmonary Hypertension

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05861479
Other study ID # 2022PI167
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date April 1, 2023

Study information
Verified date April 2023
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary Survival Death From the first visit to 1st April 2023
Primary Recurrence of acute right heart failure Hospital admission for acute right heart failure From the first visit to 1st April 2023
Primary Acute right heart failure-free survival First event: death or hospital admission for acute right heart failure From the first visit to 1st April 2023
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