Recruiting

Observational Study

Sponsor:

Echosens

Code:

NCT07222813

Conditions

Heart Failure

Heart Failure - NYHA II - IV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FibroScan

Right-sided Heart Catheterization

Transthoracic echocardiography

Blood Sample Analysis

Study Details

Brief summary:

This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation designed to explore a non-invasive, reliable alternative to invasive, catheter-based hemodynamic assessments, which are associated with procedural risks and limited applicability in certain participant populations.

Conditions

Heart Failure

Heart Failure - NYHA II - IV

Study ID

NCT07222813

Start date

Apr 23, 2026

Status verified date

Oct, 2025

Completion date

Jan 15, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Have read, understood, and signed the informed consent form (ICF)
2. Be ≥18 years of age at the time of screening
3. Have suspected or diagnosed acute or chronic HF and be scheduled to undergo right-sided cardiac catheterization

Exclusion Criteria:

1. Inability to consent
2. Chronic liver disease (self-reported alcohol use >14 drinks/week in females and >21 drinks/week in males), positive hepatitis C virus serology, positive hepatitis B surface antigen, autoimmune hepatitis, hemochromatosis, or cholestatic disease)
3. BMI >40 kg/m2
4. Fontan-type circulation
5. Ascites
6. Heart transplantation
7. Pregnancy, breastfeeding, or intent to become pregnant during the study
8. Intent to donate/bank or retrieve eggs (ova, oocytes) or donate sperm during the study

Study Design

Enrollment

149 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Full Cohort

This population will be defined by patients fulfilling all inclusion and exclusion criteria.

Interventions

FibroScan

At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM)

Right-sided Heart Catheterization

at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP)

Transthoracic echocardiography

at Day 0 assessment of cardiac function

Blood Sample Analysis

At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests

Primary outcome measure

  • Proportion of individuals with elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Sensitivity] [ Time Frame: at Day 0 ]
  • Proportion of individuals without elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Specificity] [ Time Frame: at Day 0 ]

Central Contacts and Locations

Central contacts

CAROLE MEILLEROUX, PharmD

+33622649277carole.meilleroux@echosens.com

Locations

University of Minnesota

Recruiting

Minneota, Minnesota, United States, 55455

Contacts

Tamas Alexy, MD

612-626-1240alexy001@umn.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Michele Esposito, MD

843-792-1105espositm@musc.edu

University of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 Location

Recruiting

Dallas, Texas, United States, 75390

Contacts

Ambarish Pandey, MD, MSCS, FAHA

214-645-2101ambarish.pandey@utsouthwestern.edu

More Information

Sponsor

Echosens

Last update posted

Sep 23, 2026

Last verified

Oct, 2025

Keywords

  • Fibroscan
  • Vibration Control Transient Elastography
  • Liver Stiffness Measurement
  • Guided VCTE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Echosens on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.