Myocardial Work Evaluation in Patients With PAH

NCT06567379 | Recruiting

• 1 other identifier: 2024PI
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Right ventricular function is a key determinant of survival in patients with pulmonary arterial hypertension, with right heart failure being the leading cause of death. ERS/ESC guidelines recommend evaluating RV function at diagnosis and at first reevaluation under treatment to estimate the one-year mortality risk. However, few RV function markers address both systolic function and afterload. Noninvasive myocardial work is a promising new tool that incorporates systolic function and its afterload into global longitudinal strain. Initially developed for the left ventricle, it can be adapted for the RV using pressure-strain loops. The article aims to evaluate the association of RV myocardial work parameters with the estimate one-year mortality in patients with PAH. This retrospective study will include patients diagnosed with PAH with transthoracic echocardiography and right heart catheterization within 48 hours at diagnosis and first reevaluation. Patients with unanalyzable echocardiography data will be excluded.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• One year risk mortality

  According to four model strata, estimation of one year mortality risk (low, intermediate-low, intermediate-high or high risk)

  six months

Study Arms (1)

PAH patients

Patients with heritable, idiopathic PAH or PAH associated with portal hypertension or with drugs.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PAH patients referred to PH reference center in Nancy university Hospital

You may qualify if:

• All consecutive incident patients with a diagnosis of idiopathic, heritable, drug-associated PH, or associated with portal hypertension and referred to PH reference center in Nancy university hospital.
• Transthoracic echocardiography (TTE) and a right heart catheterization (RHC) within 48 hours at diagnosis and at first reevaluation with PAH treatment

You may not qualify if:

• cardiac ultrasound data not analyzable (poor echogenicity or poor quality of RV slice). - -- Patients with PH associated with left-heart disease (group 2), PH associated with lung diseases and/or hypoxia (group 3), PH associated with pulmonary artery obstructions (group 4) and PH with unclear and/or multifactorial mechanisms (group 5) were also excluded. Patients with a positive response to the vasoreactivity test or with features of venous or capillaries involvement were also excluded.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Valentin

Nancy, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Simon Valentin, M.D.

CONTACT

+33383153405; s.valentin@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: July 25, 2024
• Primary Completion: August 25, 2024
• Study Completion: September 30, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)