Association Between Coronary and Peripheral Vascular Injury in Heart Failure Patients With Preserved Ejection Fraction.

NCT ID: NCT05884346

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-05-31

Brief Summary

Heart failure with preserved ejection fraction (HPEF, defined as LVEF ≥50%) represents 50% of hospital admissions for heart failure. Although its morbi-mortality is similar to that of heart failure with reduced ejection fraction (HFPEF), it remains an unknown disease with limited data especially from an etiological point of view. The underlying causes are imperfectly understood, and more than half of the patients have HPEF labeled "idiopathic."

A non-hierarchical clustering study of HPEF patients led to the identification of a subgroup of patients (25%) with a predominant coronary vascular phenotype (i.e., a history of coronary stenosis with or without the need for revascularization). In these patients, vascular endothelial dysfunction would play a central role in the development and progression of heart failure.One of the mechanisms leading to HPEF could be a decrease in the bioavailability of nitric oxide (NO) involved in the relaxation of the cardiac muscle. As the mechanism of action of NO is pleiotropic, a decrease in NO bioavailability could also be observed at the peripheral level, favoring in the long term the development of unfavorable vascular remodeling, for example in the small digital or retinal arteries.Some HPEF patients could thus be distinguished from others by their predominant "vascular" profile. The link between HPEF and endothelial dysfunction has been suspected but never clearly demonstrated.

Ultra-high frequency ultrasound is an innovative technology to estimate the remodeling of small distal arteries in a non-invasive way. The investigators propose to use this imaging on digital arteries in HPEF patients and to study the association with known coronary macrovascular damage.The remodeling parameters will be measured and compared in patients with HPEF with or without identified macrovascular coronary disease.This characterization of arterial remodeling on the digital arteries could be a powerful tool for non-invasive screening in the identification of a subgroup of HPEF that is still considered idiopathic.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Heart Failure Preserved Ejection Fraction with coronary disease

Group Type: OTHER

Ultrahigh-frequency ultrasound

Intervention Type: OTHER

Arterial remodeling of the digital arteries will be measured by ultrahigh-frequency ultrasound and will be compared in heart failure patients with preserved ejection fraction with and without identified macroscopic coronary disease

Heart Failure Preserved Ejection Fraction without coronary disease

Group Type: OTHER

Ultrahigh-frequency ultrasound

Intervention Type: OTHER

Arterial remodeling of the digital arteries will be measured by ultrahigh-frequency ultrasound and will be compared in heart failure patients with preserved ejection fraction with and without identified macroscopic coronary disease

Interventions

Ultrahigh-frequency ultrasound

Arterial remodeling of the digital arteries will be measured by ultrahigh-frequency ultrasound and will be compared in heart failure patients with preserved ejection fraction with and without identified macroscopic coronary disease

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Group 1 :

• Patients who are ≥ 18 years old
• Heart failure with preserved ejection fraction (LVEF ≥ 50%)
• B-type natriuretic peptide (BNP) > 35 pg/mL at inclusion
• Coronary macrovascular disease (significant coronary stenosis, which may have required revascularization by stenting or coronary bypass surgery).

Group 2 :

• Patients who are ≥ 18 years old
• Heart failure with preserved ejection fraction (LVEF ≥ 50%)
• B-type natriuretic peptide (BNP) > 35 pg/mL at screening
• Absence of coronary macrovascular disease (no significant coronary atheroma (< 30%) or history of stenting or coronary bypass surgery).

Group 1 and group 2 :

• Patients under legal protection
• Patients not affiliated to a Social Security system
• Patient under State Medical Help (France - AME)
• Pregnancy or breastfeeding
• Refusal or inability to sign consent
• Known and treated retinal vasculopathy
• Severe or non-stabilized hypertension (BP > 180/100 mmHg at screening)
• History of LVEF < 40%.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roxane GAÏSSET, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital européen Georges Pompidou - AP-HP

Paris, , France

Countries

France

Central Contacts

Annie BERGERA

Role: CONTACT

gestion-locale.drc@aphp.fr

(0)1 44 84 17 24 ext. 33

Natacha NOHILE

Role: CONTACT

natacha.nohile@aphp.fr

Facility Contacts

Roxane GAÏSSET, MD

Role: primary

roxane.gaisset@aphp.fr

156095398 ext. 33

Jean-Sébastien HULOT, MD-PhD

Role: backup

Other Identifiers

2022-A02455-38

Identifier Type: OTHER

Identifier Source: secondary_id

23.00664.000175

Identifier Type: OTHER

Identifier Source: secondary_id

APHP230214

Identifier Type: -

Identifier Source: org_study_id