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

NCT05884346 | Unknown

• 3 other identifiers: APHP2302142022-A02455-3823.00664.000175
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

Ultrahigh-frequency ultrasound; Heart Failure with Preserved Ejection Fraction; Microcirculation; Arterial remodeling; Small arteries; Ischemia

Outcome Measures

Primary Outcomes (1)

• Digital vascular remodeling by ultrahigh-frequency ultrasound

  The wall-to-lumen ratio of digital arteries recorded with ultrahigh-frequency ultrasound.

  Day 1

Secondary Outcomes (6)

• Radial vascular remodeling by echo-tracking

  Day 1

• Carotid vascular remodeling by echo-tracking

  Day 1

• Endothelial dysfunction

  Day 1

• Pulse wave velocity

  Day 1

• Retinal microvascularization

  Day 1

Study Arms (2)

Heart Failure Preserved Ejection Fraction with coronary disease

OTHER

Other: Ultrahigh-frequency ultrasound

Heart Failure Preserved Ejection Fraction without coronary disease

OTHER

Other: Ultrahigh-frequency ultrasound

Interventions

Ultrahigh-frequency ultrasound 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 with coronary disease; Heart Failure Preserved Ejection Fraction without coronary disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1 :
• Patients who are ≥ 18 years old
• Heart failure with preserved ejection fraction (LVEF ≥ 50%)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hôpital européen Georges Pompidou - AP-HP

Paris, 75015, France

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roxane GAÏSSET, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie BERGERA

CONTACT

(0)1 44 84 17 24; gestion-locale.drc@aphp.fr

Natacha NOHILE

CONTACT

natacha.nohile@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 1, 2023
• Study Start: June 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)