Heart Failure With Preserved Ejection FractionCOROVASCNCT05884346
Association Between Coronary and Peripheral Vascular Injury in Heart Failure Patients With Preserved Ejection Fraction.
A study testing Ultrahigh-frequency ultrasound in people with Heart Failure With Preserved Ejection Fraction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Ultrahigh-frequency ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
Show all 20Show fewer
- 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%.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Natacha NOHILE contact
France1 site
Hôpital européen Georges Pompidou - AP-HP
Paris, 75015
Roxane GAÏSSET, MD, 156095398 ext. 33, roxane.gaisset@aphp.fr
Jean-Sébastien HULOT, MD-PhD
About this study
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.
- Being tested
- Ultrahigh-frequency ultrasound
- Keywords
- Ultrahigh-frequency ultrasound, Heart Failure with Preserved Ejection Fraction, Microcirculation, Arterial remodeling, Small arteries, Ischemia
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrahigh-frequency ultrasoundOther
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
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Preserved Ejection Fraction with coronary disease | Other | Not described Receives: Other: Ultrahigh-frequency ultrasound |
| Heart Failure Preserved Ejection Fraction without coronary disease | Other | Not described Receives: Other: Ultrahigh-frequency ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital vascular remodeling by ultrahigh-frequency ultrasound
The wall-to-lumen ratio of digital arteries recorded with ultrahigh-frequency ultrasound.
Measured: Day 1
Secondary outcomes (6)
Radial vascular remodeling by echo-tracking
Measurement of peripheral vascular remodeling on radial arteries by arterial distension parameters.
Measured: Day 1
Carotid vascular remodeling by echo-tracking
Measurement of peripheral vascular remodeling on carotid arteries by arterial distension parameters.
Measured: Day 1
Endothelial dysfunction
Level of endothelial function measured by arterial flow-mediated vasodilation (FMD, expressed in %).
Measured: Day 1
Pulse wave velocity
Pulse wave velocity (PWV, velocity expressed in m/s) carotid-femoral (aortic elasticity).
Measured: Day 1
Retinal microvascularization
To study the retinal microvascularization by Optical Coherence Tomography Angiography (OCT-A) : density measurement per sector (% per studied area).
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roxane GAÏSSET, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884346
- Sponsor's protocol ID
- APHP230214
- Other IDs
- 2022-A02455-38, 23.00664.000175
- Acronym
- COROVASC
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Coronary and Peripheral Vascular Injury in Heart Failure Patients With Preserved Ejection Fraction.
- ClinicalTrials.gov ID
- NCT05884346
- Acronym / sponsor ID
- COROVASC / APHP230214
- Keywords
- Ultrahigh-frequency ultrasound, Heart Failure with Preserved Ejection Fraction, Microcirculation, Arterial remodeling, Small arteries, Ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jun 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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).
- Patients who are ≥ 18 years old
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrahigh-frequency ultrasoundArterial 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 | Other | Heart Failure Preserved Ejection Fraction with coronary disease, Heart Failure Preserved Ejection Fraction without coronary disease |
Primary outcome
Digital vascular remodeling by ultrahigh-frequency ultrasound
Time frame: Day 1
The wall-to-lumen ratio of digital arteries recorded with ultrahigh-frequency ultrasound.
6 secondary outcomes
Radial vascular remodeling by echo-tracking
Time frame: Day 1
Carotid vascular remodeling by echo-tracking
Time frame: Day 1
Endothelial dysfunction
Time frame: Day 1
Pulse wave velocity
Time frame: Day 1
Retinal microvascularization
Time frame: Day 1
Calcium score
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
ELEVATE-HFpEF Clinical Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natacha NOHILE contact
Roxane GAÏSSET, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrahigh-frequency ultrasound in people with Heart Failure With Preserved Ejection Fraction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie BERGERA ((0)1 44 84 17 24 ext. 33, gestion-locale.drc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital vascular remodeling by ultrahigh-frequency ultrasound (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.