## Protocol Section
### Identification Module
**NCT ID:** NCT05861479

**Brief Title:** Prognostic Value of Estimated Plasma Volume in Pulmonary Hypertension

**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

#### Organization Study ID Info
**ID:** 2022PI167
#### Organization
**Class:** OTHER
**Full Name:** Central Hospital, Nancy, France
### Status Module
#### Completion Date
**Date:** 2023-04-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-01-01

**Type:** ACTUAL

#### Start Date
**Date:** 2015-01-01

**Type:** ACTUAL

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2023-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-05
**Study First Submit QC Date:** 2023-05-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Central Hospital, Nancy, France

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pulmonary Arterial Hypertension

- Chronic Thromboembolic Pulmonary Hypertension

- Acute Right Heart Failure

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Death

**Measure:** Survival

**Time Frame:** From the first visit to 1st April 2023

**Description:** Hospital admission for acute right heart failure

**Measure:** Recurrence of acute right heart failure

**Time Frame:** From the first visit to 1st April 2023

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

**Measure:** Acute right heart failure-free survival

**Time Frame:** From the first visit to 1st April 2023

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000006331

- Term: Heart Diseases

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M10027

- Name: Hypertension, Pulmonary

- Relevance: HIGH

- As Found: Pulmonary Hypertension

- ID: M2261

- Name: Pulmonary Arterial Hypertension

- Relevance: HIGH

- As Found: Pulmonary Arterial Hypertension

- ID: M30541

- Name: Familial Primary Pulmonary Hypertension

- Relevance: HIGH

- As Found: Pulmonary Arterial Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T4807

- Name: Pulmonary Arterial Hypertension

- Relevance: HIGH

- As Found: Pulmonary Arterial Hypertension

- ID: T1316

- Name: Chronic Thromboembolic Pulmonary Hypertension

- Relevance: HIGH

- As Found: Chronic Thromboembolic Pulmonary Hypertension

### Condition Browse Module - Meshes

- ID: D000006976

- Term: Hypertension, Pulmonary

- ID: D000081029

- Term: Pulmonary Arterial Hypertension

- ID: D000065627

- Term: Familial Primary Pulmonary Hypertension

- ID: D000006973

- Term: Hypertension

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-24
