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

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrahigh-frequency ultrasound
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure With Preserved Ejection Fraction focused on measuring Ultrahigh-frequency ultrasound, Heart Failure with Preserved Ejection Fraction, Microcirculation, Arterial remodeling, Small arteries, Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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). Non-inclusion Criteria : 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%.

Sites / Locations

  • Hôpital européen Georges Pompidou - AP-HP

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Heart Failure Preserved Ejection Fraction with coronary disease

Heart Failure Preserved Ejection Fraction without coronary disease

Arm Description

Outcomes

Primary Outcome Measures

Digital vascular remodeling by ultrahigh-frequency ultrasound
The wall-to-lumen ratio of digital arteries recorded with ultrahigh-frequency ultrasound.

Secondary Outcome Measures

Radial vascular remodeling by echo-tracking
Measurement of peripheral vascular remodeling on radial arteries by arterial distension parameters.
Carotid vascular remodeling by echo-tracking
Measurement of peripheral vascular remodeling on carotid arteries by arterial distension parameters.
Endothelial dysfunction
Level of endothelial function measured by arterial flow-mediated vasodilation (FMD, expressed in %).
Pulse wave velocity
Pulse wave velocity (PWV, velocity expressed in m/s) carotid-femoral (aortic elasticity).
Retinal microvascularization
To study the retinal microvascularization by Optical Coherence Tomography Angiography (OCT-A) : density measurement per sector (% per studied area).
Calcium score
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.

Full Information

First Posted
May 10, 2023
Last Updated
June 1, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT05884346
Brief Title
Association Between Coronary and Peripheral Vascular Injury in Heart Failure Patients With Preserved Ejection Fraction.
Acronym
COROVASC
Official Title
Association Between Coronary and Peripheral Vascular Injury in Heart Failure Patients With Preserved Ejection Fraction.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
Ultrahigh-frequency ultrasound, Heart Failure with Preserved Ejection Fraction, Microcirculation, Arterial remodeling, Small arteries, Ischemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart Failure Preserved Ejection Fraction with coronary disease
Arm Type
Other
Arm Title
Heart Failure Preserved Ejection Fraction without coronary disease
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Ultrahigh-frequency ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
Digital vascular remodeling by ultrahigh-frequency ultrasound
Description
The wall-to-lumen ratio of digital arteries recorded with ultrahigh-frequency ultrasound.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Radial vascular remodeling by echo-tracking
Description
Measurement of peripheral vascular remodeling on radial arteries by arterial distension parameters.
Time Frame
Day 1
Title
Carotid vascular remodeling by echo-tracking
Description
Measurement of peripheral vascular remodeling on carotid arteries by arterial distension parameters.
Time Frame
Day 1
Title
Endothelial dysfunction
Description
Level of endothelial function measured by arterial flow-mediated vasodilation (FMD, expressed in %).
Time Frame
Day 1
Title
Pulse wave velocity
Description
Pulse wave velocity (PWV, velocity expressed in m/s) carotid-femoral (aortic elasticity).
Time Frame
Day 1
Title
Retinal microvascularization
Description
To study the retinal microvascularization by Optical Coherence Tomography Angiography (OCT-A) : density measurement per sector (% per studied area).
Time Frame
Day 1
Title
Calcium score
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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). Non-inclusion Criteria : 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%.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie BERGERA
Phone
(0)1 44 84 17 24
Ext
33
Email
gestion-locale.drc@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Natacha NOHILE
Email
natacha.nohile@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roxane GAÏSSET, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital européen Georges Pompidou - AP-HP
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roxane GAÏSSET, MD
Phone
156095398
Ext
33
Email
roxane.gaisset@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jean-Sébastien HULOT, MD-PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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