## Protocol Section
### Identification Module
**NCT ID:** NCT04792879

**Acronym:** CODOVEIN

**Brief Title:** Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension

**Official Title:** Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension

#### Organization Study ID Info
**ID:** 2021-A00100-41
#### Organization
**Class:** OTHER
**Full Name:** Poitiers University Hospital
### Status Module
#### Completion Date
**Date:** 2022-11-21

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-01

**Type:** ACTUAL

**Last Update Submit Date:** 2022-11-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-11-21

**Type:** ACTUAL

#### Start Date
**Date:** 2021-06-14

**Type:** ACTUAL

**Status Verified Date:** 2022-11

#### Study First Post Date
**Date:** 2021-03-11
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-08
**Study First Submit QC Date:** 2021-03-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Poitiers University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Occurrence of acute right heart failure (ARHF) remains common during pulmonary hypertension (PH). Right atrial pressure (RAP) invasive measurement is the gold standard to diagnose ARHF in order to improve diuretic treatment management. Existence of indirect signs of ARHF on venous Doppler ultrasound waveform has long been described, but correlation with RAP has not been properly established yet. It is the aim of our study in order to obtain an additional tool to manage ARHF.

### Conditions Module

**Conditions:**

- Acute Right Heart Failure

- Pulmonary Hypertension

- Peripheral Veins Doppler Ultrasound

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 103

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: Peripheral veins Doppler ultrasound

**Label:** Peripheral veins Doppler ultrasound

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Peripheral veins Doppler ultrasound

**Description:** Patients undergoing a right heart catheterization for PH diagnosis or annual follow-up in the cardiological unit of the university hospital of Poitiers will be included. A venous Doppler ultrasound will be performed by a vascular physician, with experience in vascular ultrasound imaging, within 4 hours before the right heart catheterization. Morphological parameters of vena cava, and velocimetric parameters of femoral, jugular and supra-hepatic veins will be assessed in order to study their correlation with right auricular pressure value.

**Name:** Peripheral veins Doppler ultrasound

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index\*, measured by Pulsed Doppler on common femoral veins, as a diagnostic criterion for ARHF (defined by RAP ≥10 mm Hg).

\* Defined as duration of non-anterograde venous flow during 3 seconds/ 3 seconds

**Measure:** Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index

**Time Frame:** Inclusion day within 4 hours before the right heart catheterization

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patient (age ≥ 18 years old)
* Patient referred to the cardiology department for a right heart catheterization with measurement of RAP, regardless of the indication.
* Free subject, without guardianship or curatorship or subordination
* People affiliated to or beneficiary of a social security schemes
* Informed consent signed by the patient after clear and fair information about the study.

Exclusion Criteria:

* Minor patient (age \< 18 years)
* Refusal to participate in the study
* Patient with hemodynamic instability, unable to tolerate a delay in treatment caused by the ultrasound examination.
* Patient requiring diuretic treatment within the next 4 hours
* Patient with a life expectancy of less than 24 hours.
* History of proximal deep venous thrombosis involving the inferior vena cava and/or common iliac veins and/or femoral veins.
* History of extrinsic venous compression on the inferior vena cava and/or common iliac veins and/or femoral veins.
* Persons who do not benefit from a Social Security scheme or who do not benefit from it through a third party.
* Persons benefiting from reinforced protection, namely minors, pregnant and nursing women, persons deprived of liberty by a judicial or administrative decision, persons staying in health or social institutions, adults under legal protection and finally patients in emergency situations.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Poitiers

**Country:** France

**Facility:** CHU de Poitiers

## 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: 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: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006976

- Term: Hypertension, Pulmonary

- ID: D000006973

- Term: Hypertension

- ID: D000006333

- Term: Heart Failure

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T204

- Name: Kava

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
