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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension; 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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

One hundred patients with idiopathic, heritable, drug-induced, connective tissue disease-associated, porto-pulmonary or HIV-associated disease were enrolled. At the diagnosis visit, mean±SD age was 59±12 years, 56% of the patients were women and most patients were in World Health Organization/New York Heart Association (WHO/NYHA) Functional Class III or IV.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Death	From the first visit to 1st April 2023
Recurrence of acute right heart failure	Hospital admission for acute right heart failure	From the first visit to 1st April 2023
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Failure; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 2022PI167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No