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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction
• Interventions: Other: Ultrahigh-frequency ultrasound

• Registration Number: NCT05884346
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-22
• Study Start: 2023-06
• Study First Posted: 2023-06-01
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-02
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heart Failure Preserved Ejection Fraction with coronary disease	Ultrahigh-frequency ultrasound	-
Heart Failure Preserved Ejection Fraction without coronary disease	Ultrahigh-frequency ultrasound	-

Primary Outcome Measures

Name	Time	Method
Digital vascular remodeling by ultrahigh-frequency ultrasound	Day 1	The wall-to-lumen ratio of digital arteries recorded with ultrahigh-frequency ultrasound.

Secondary Outcome Measures

Name	Time	Method
Carotid vascular remodeling by echo-tracking	Day 1	Measurement of peripheral vascular remodeling on carotid arteries by arterial distension parameters.
Retinal microvascularization	Day 1	To study the retinal microvascularization by Optical Coherence Tomography Angiography (OCT-A) : density measurement per sector (% per studied area).
Radial vascular remodeling by echo-tracking	Day 1	Measurement of peripheral vascular remodeling on radial arteries by arterial distension parameters.
Endothelial dysfunction	Day 1	Level of endothelial function measured by arterial flow-mediated vasodilation (FMD, expressed in %).
Pulse wave velocity	Day 1	Pulse wave velocity (PWV, velocity expressed in m/s) carotid-femoral (aortic elasticity).
Calcium score	Day 1	Compare the calcium score (expressed by the Agatston score) in patients with heart failure with preserved ejection fraction with or without a priori coronary artery disease.

Trial Locations

Locations (1)

Hôpital européen Georges Pompidou - AP-HP; 🇫🇷 Paris, France