Heart FailureNCT04189029
PACIFIC-PRESERVED : PhenomApping, ClassIFication, and Innovation for Cardiac Dysfunction - HF With PRESERVED LVEF Study
An observational study of Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This is a prospective multicenter study to decipher phenotypic variability within patients with heart failure and preserved left ventricular ejection fraction (HFpEF). From a registry of heart failure patients (2500 anticipated) hospitalized in the participating centers in the last 3 years, up to 300 participants… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Extensive phenotyping
- Type of treatment
- Injection or infusion
- How many people
- 175 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2019to Dec 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with different forms of heart failure (ie with preserved left ventricular ejection fraction vs. reduced left ventricular ejection fraction) and subjects apparently without heart failure
Who may be able to join
- All subjects
- Affiliation to a social security scheme, universal medical coverage (CMU) or any equivalent scheme
- Physical state compatible with the carrying out of the investigations according to the judgment of the investigator
- Procedure for obtaining consent
- For HFpEF patients:
- Hospitalization in one of the partner hospitals in the last 30 months
Show all 24Show fewer
- With a diagnosis of symptomatic congestive heart failure (NYHA II to IV)
- With a plasma concentration of BNP ≥ 100 μg / ml or NT-proBNP ≥ 300 μg / ml or having had an administration of a dose of intravenous diuretics during hospitalization for congestive heart failure
- Left ventricular ejection fraction ≥ 50%
- Hospital discharge for at least 2 months
- For HFrEF patients:
- Hospitalization in one of the partner hospitals in the last 30 months
- With a diagnosis of symptomatic congestive heart failure (NYHA II to IV)
- Plasma concentration of BNP ≥ 100 μg / ml or NT-proBNP ≥ 300 μg / ml or administered a dose of intravenous diuretics during hospitalization for congestive heart failure
- Hospital discharge for at least 2 months
- Left ventricular ejection fraction ≤ 40%
- Matched age and sex to HFpEF patients (for participants to extensive phenotyping)
- For subjects apparently without heart failure :
- Subject without a notable medical history or medical history within the last 5 years
- Normotensive or who may have an essential hypertension of grade 1 (≤159 / 99 mmHg), treated or not
- Can present a dyslipidemia, treated by hygieno-dietetic measures alone
- Sinus heart rate
- Estimated glomerular filtration rate ≥ 60 ml / min (CKD epi)
- Matched age and sex to HFpEF patients (for participants to extensive phenotyping)
Who cannot join
- All subjects
- Pregnancy or breastfeeding
- Participation in another interventional study
- Person placed under the safeguard of justice
- Subject that can not understand the procedures related to the protocol
- Severe obesity (BMI > 40 Kg / m2)
Show all 27Show fewer
- For those performing the injected MRI: Patient who has already had a severe allergy to gadolinium MRI contrast agents
- For those performing the injected MRI: MRI usual contraindications: Pace-maker, defibrillator, metallic objects
- Administration of a vaccine dose (including anti-Sars-Cov-2) less than 3 weeks old
- For both HFpEF and HFrEF patients:
- History of right ventricular infarction
- History of cardiac transplantation or circulatory assistance
- Major surgery scheduled for less than 6 months, coronary revascularization of less than 3 months
- Pacemaker or any implanted device (or foreign body) not compatible with MRI
- Presence of very severe co-morbidity: end-stage renal failure (GFR <15ml / min), severe chronic obstructive pulmonary disease (COPD), severe valve disease (including severe aortic stenosis), organ transplantation
- Hypertrophic cardiomyopathy of known genetic cause
- Hereditary amyloidosis with disabling neuropathy
- Amyloidosis under specific treatment
- Other antecedent of known congenital heart disease type, Post-embolic chronic pulmonary heart, Restrictive Cardiopathy, Diagnosed Fabry Disease
- For HFpEF patients:
- History of systolic dysfunction with proven LVEF reduction (≤ 40%)
- For subjects apparently without heart failure :
- Medication use other than pure systemic or local estrogen / progestin and progestin contraceptives and paracetamol, at the discretion of the investigator
- Acute pathology within 8 days prior to inclusion
- Cardiac or vascular organic impairment or apparent chronic diseases
- Chronic treatment outside a treatment for high blood pressure
- Having already had ≥3 MRI with injection of gadolinium contrast agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Redefining the Phenotypic Spectrum of Heart Failure With Preserved Ejection Fraction (HFpEF) by Deep Phenotyping and Machine Learning Methods: The PACIFIC-PRESERVED Study (PhenomApping, ClassIFication, and Innovation for Cardiac Dysfunction - HF With PRESERVED LVEF Study)
This is a prospective multicenter study to decipher phenotypic variability within patients with heart failure and preserved left ventricular ejection fraction (HFpEF). From a registry of heart failure patients (2500 anticipated) hospitalized in the participating centers in the last 3 years, up to 300 participants (with a final ratio of 3 HFpEF patients, 2 patients with heart failure and reduced ejection fraction (HFrEF) and 1 matched subjects without heart failure will be enrolled for an extensive phenotyping with physical evaluation, biomarkers and omics, cardiac and vascular imaging and telemonitoring of cardiovascular parameters. Cluster analysis with machine learning methods will be performed to define phenogroups unique to the HFpEF patient population.
Read the detailed description
Heart failure with preserved ejection fraction (HFpEF) is a complex and prevalent syndrome with currently no efficient therapy. This syndrome is likely explained by different pathophysiological inputs leading to common symptoms of heart failure. These pathophysiological abnormalities can primarily involve the heart but also other organs with secondary impact on the myocardium. There is however no clear understanding and diagnostic algorithms of the different HFpEF subpopulations. Novel mathematical methods (such as machine learning) can help identifying clusters within an heterogeneous population such as HFpEF patients.
A registry (2500 anticipated) will be constituted with patients hospitalized for congestive heart failure in the participating centers during the last 3 years. From this registry, up to 500 patients will be invited to visit in the hospital for 8-10 hours for physical examination, ECG, performance-based tests, blood draw, cMRI, echocardiography (rest and low-level exercise), Ultrafast echo (for non-invasive measurement of myocardial stiffness), low radiation cardiac CT (for calcium scoring), non-invasive measurement of arterial stiffness. They will be asked to fill out questionnaires about dyspnea, depression and about general health and quality of life. They will then be equipped with a smart connected garment (with cardiovascular \& hemodynamic sensors), a connected weight balance and a blood pressure monitoring device for telemonitoring collection of cardiovascular hemodynamic parameters in real-life conditions (for 14 days).
Patients included in the registry will be followed-up for 3 years using medico-administrative databases and vital status, cardiovascular and heart failure outcomes will be collected.
- Being tested
- Extensive phenotyping
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensive phenotypingOther
Prospective assessment of physical evaluation, biomarkers and omics, cardiac and vascular imaging and telemonitoring of cardiovascular parameters for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| HFpEF patients | Heart failure patients (NYHA II-IV) with left ventricular ejection fraction ≥ 50%, 1000 patients anticipated among which up to 300 with extensive phenotyping Receives: Other: Extensive phenotyping | |
| HFrEF patients | Heart failure patients (NYHA II-IV) with left ventricular ejection fraction ≤ 40%, 1000 patients anticipated among which up to 100 with extensive phenotyping (age- and gender-matched on participating HFpEF patients) Receives: Other: Extensive phenotyping | |
| Subjects apparently without heart failure | Subjects without history or signs of heart failure, up to 100 subjects anticipated with extensive phenotyping (age- and gender-matched on participating HFpEF patients) Receives: Other: Extensive phenotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Machine learning algorithm to identify distinct phenotypic subgroups among HFpEF patients
Machine learning-based cluster analysis using extensive phenotyping data from HFpEF, HFrEF and subjects without apparent HF
Measured: 14 days
Secondary outcomes (23)
Prognosis
Identify phenotypic subgroup(s) with higher risk of cardiovascular and HF outcomes
Measured: 3 years
Myocardial stiffness
Assess the diagnostic and prognostic value of myocardial stiffness measured with ultrafast cardiac echography
Measured: 3 years
Sarcopenia and muscular capacity
Prevalence and importance of muscle loss, weakness measured with hand grip strength test (Kg) and with the short physical performance battery (SPPB, combining the results of gait speed, chair stand and balance tests) in HFpEF patients
Measured: 3 years
Exercise tolerance
Measure exercise tolerance with 6-minute walk test
Measured: 3 years
Cardiac fibrosis
Prevalence, diagnostic and prognostic importance of cardiac fibrosis (as estimated by cMRI and specific biological markers) in HFpEF patients
Measured: 3 years
Arterial Stiffness
Assess the diagnostic and prognostic value of arterial stiffness measured by pulse wave velocity
Measured: 3 years
Right heart and pulmonary circulation
Assess the diagnostic and prognostic value of novel markers to quantify right heart function and pulmonary circulation measured with cMRI
Measured: 3 years
Ventricular-arterial coupling
Machine learning-based analysis on 4D MRI recordings to estimate ventricular-arterial coupling
Measured: 3 years
Omics signature
Apply multi-omics techniques (including measurements of miRNA, lNcRNA, inflammation markers, and DNA methylation level) to define specific biological signatures to HF and HFpEF patients
Measured: 3 years
Quality of life evaluation
General and HF QOL questionnaires: Kansas city cardiomyopathy questionnaire - the sum of responses from all 12 items, Range for subscale is 0-100 and the range for the summary score is 0-100 with lower scores indicating more significant disease impact; Global quality of life score with SF36 (Short form 36 health survey): The norm data is 0-100, the health related quality of life is increased as the scores are increased.
Measured: 3 years
Telemonitoring of weight
Remote measurement of body weight
Measured: 3 years
Telemonitoring of cardiac rythm
Remote measurement of cardiac arrhythmias
Measured: 3 years
Telemonitoring of ECG
Remote measurement of heart rate variability
Measured: 3 years
Telemonitoring of physical activity
Remote measurement of physical activity with an actimeter
Measured: 3 years
Telemonitoring of blood pressure
Remote measurements of blood pressure in mmHg
Measured: 3 years
Telemonitoring of pulmonary function
Remote measurement of respiratory rate
Measured: 3 years
Telemonitoring of oxygen saturation
Remote measurement of oxygen saturation (%)
Measured: 3 years
Telemonitoring of pulmonary congestion
Remote evaluation of pulmonary congestion with measurement of thoracic impedance
Measured: 3 years
Digitalized ECG
Develop novel machine learning based markers of HF, of HFpEF and HFrEF
Measured: 3 years
Cardiac echography
Rest and low-effort evaluation of cardiac parameters
Measured: 3 years
Cardiac calcium scoring
Evaluation of calcium scoring among participants
Measured: 3 years
Cardiac MRI
Novel biomarkers of cardiac fibrosis, extra-cellular volume, matrix remodeling
Measured: 3 years
Left atria
Evaluation of LA remodeling (volumes) and function (strain)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start9 Dec 2019
- Primary completion9 Dec 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- BPIfrance, Sanofi, Institut de Recherches Internationales Servier, Institut National de la Santé Et de la Recherche Médicale, France, BioSerenity, Casis, Firalis SA, Fealinx, Centre National de la Recherche Scientifique, France, ESPCI Paris, University of Paris 5 - Rene Descartes, Sorbonne University
- Responsible party
- Sponsor
- Investigators
- Jean-Sébastien HULOT, MD PhD, Principal investigator, AP - HP, Hôpital Européen Georges-Pompidou, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189029
- Sponsor's protocol ID
- APHP190558
- Other IDs
- 2019-A01795-52
- Status last verified
- Mar 2024
- First submitted
- 28 Nov 2019
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data used for publication could be shared through scientific collaboration with the sponsor or any collaborations implied.The sharing will respect the unital consortium agreement.
Publications
Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
PubMed 24491689De Peretti, et al. Prévalence et statut fonctionnel des cardiopathies ischémiques et de l'insuffisance cardiaque dans la population adulte en France : apports des enquêtes déclaratives " Handicap-Santé " BEH 2014; (9-10):172-81
Galinier M, et al. Parcours de Soins. Dossier insuffisance cardiaque, encore trop d'hospitalisations pourtant évitables. État des lieux en France en 2013. Le Concours Médical 2013; 135(6):443-7
Lindenfeld J, Albert NM, Boehmer JP et coll. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010 ; 16 (6): e1-e194. - Arnold JM, Liu P, Demers C et coll. Canadian Cardiovascular Society consensus conference recommendations on heart failure 2006: diagnosis and management. Can J Cardiol 2006 ; 22 (1) : 23-45
Blanc - SVSE 1 - Physiologie, physiopathologie, santé publique (Blanc SVSE 1) 2013
Vasan RS, Levy D. The role of hypertension in the pathogenesis of heart failure. A clinical mechanistic overview. Arch Intern Med. 1996 Sep 9;156(16):1789-96.
PubMed 8790072Fonarow GC, Stough WG, Abraham WT, Albert NM, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007 Aug 21;50(8):768-77. doi: 10.1016/j.jacc.2007.04.064. Epub 2007 Aug 6.
PubMed 17707182CDC statistics 2016; AHA Heart disease and stoke statistics 2017; European CVD statistics 2017 ; Dunlay S et al 2017 Nat Rev Cardiol
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
PubMed 27207191Zile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE; I-PRESERVE Investigators. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation. 2011 Dec 6;124(23):2491-501. doi: 10.1161/CIRCULATIONAHA.110.011031. Epub 2011 Nov 7.
PubMed 22064591Katz DH, Beussink L, Sauer AJ, Freed BH, Burke MA, Shah SJ. Prevalence, clinical characteristics, and outcomes associated with eccentric versus concentric left ventricular hypertrophy in heart failure with preserved ejection fraction. Am J Cardiol. 2013 Oct 15;112(8):1158-64. doi: 10.1016/j.amjcard.2013.05.061. Epub 2013 Jun 28.
PubMed 23810323Lam CS, Roger VL, Rodeheffer RJ, Bursi F, Borlaug BA, Ommen SR, Kass DA, Redfield MM. Cardiac structure and ventricular-vascular function in persons with heart failure and preserved ejection fraction from Olmsted County, Minnesota. Circulation. 2007 Apr 17;115(15):1982-90. doi: 10.1161/CIRCULATIONAHA.106.659763. Epub 2007 Apr 2.
PubMed 17404159Persson H, Lonn E, Edner M, Baruch L, Lang CC, Morton JJ, Ostergren J, McKelvie RS; Investigators of the CHARM Echocardiographic Substudy-CHARMES. Diastolic dysfunction in heart failure with preserved systolic function: need for objective evidence:results from the CHARM Echocardiographic Substudy-CHARMES. J Am Coll Cardiol. 2007 Feb 13;49(6):687-94. doi: 10.1016/j.jacc.2006.08.062. Epub 2007 Jan 26.
PubMed 17291934Shah AM, Claggett B, Kitzman D, Biering-Sorensen T, Jensen JS, Cheng S, Matsushita K, Konety S, Folsom AR, Mosley TH, Wright JD, Heiss G, Solomon SD. Contemporary Assessment of Left Ventricular Diastolic Function in Older Adults: The Atherosclerosis Risk in Communities Study. Circulation. 2017 Jan 31;135(5):426-439. doi: 10.1161/CIRCULATIONAHA.116.024825. Epub 2016 Dec 7.
PubMed 27927714Borbely A, van der Velden J, Papp Z, Bronzwaer JG, Edes I, Stienen GJ, Paulus WJ. Cardiomyocyte stiffness in diastolic heart failure. Circulation. 2005 Feb 15;111(6):774-81. doi: 10.1161/01.CIR.0000155257.33485.6D. Epub 2005 Feb 7.
PubMed 15699264
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redefining the Phenotypic Spectrum of Heart Failure With Preserved Ejection Fraction (HFpEF) by Deep Phenotyping and Machine Learning Methods: The PACIFIC-PRESERVED Study (PhenomApping, ClassIFication, and Innovation for Cardiac Dysfunction - HF With PRESERVED LVEF Study)
- ClinicalTrials.gov ID
- NCT04189029
- Acronym / sponsor ID
- APHP190558
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- BPIfrance, Sanofi, Institut de Recherches Internationales Servier, Institut National de la Santé Et de la Recherche Médicale, France, BioSerenity, Casis, Firalis SA, Fealinx, Centre National de la Recherche Scientifique, France, ESPCI Paris, University of Paris 5 - Rene Descartes, Sorbonne University
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 9 Dec 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Dec 2019 (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.
This is a prospective multicenter study to decipher phenotypic variability within patients with heart failure and preserved left ventricular ejection fraction (HFpEF). From a registry of heart failure patients (2500 anticipated) hospitalized in the participating centers in the last 3 years, up to 300 participants (with a final ratio of 3 HFpEF patients, 2 patients with heart failure and reduced ejection fraction (HFrEF) and 1 matched subjects without heart failure will be enrolled for an extensive phenotyping with physical evaluation, biomarkers and omics, cardiac and vascular imaging and telemonitoring of cardiovascular parameters. Cluster analysis with machine learning methods will be performed to define phenogroups unique to the HFpEF patient population.
Detailed description
Heart failure with preserved ejection fraction (HFpEF) is a complex and prevalent syndrome with currently no efficient therapy. This syndrome is likely explained by different pathophysiological inputs leading to common symptoms of heart failure. These pathophysiological abnormalities can primarily involve the heart but also other organs with secondary impact on the myocardium. There is however no clear understanding and diagnostic algorithms of the different HFpEF subpopulations. Novel mathematical methods (such as machine learning) can help identifying clusters within an heterogeneous population such as HFpEF patients.
A registry (2500 anticipated) will be constituted with patients hospitalized for congestive heart failure in the participating centers during the last 3 years. From this registry, up to 500 patients will be invited to visit in the hospital for 8-10 hours for physical examination, ECG, performance-based tests, blood draw, cMRI, echocardiography (rest and low-level exercise), Ultrafast echo (for non-invasive measurement of myocardial stiffness), low radiation cardiac CT (for calcium scoring), non-invasive measurement of arterial stiffness. They will be asked to fill out questionnaires about dyspnea, depression and about general health and quality of life. They will then be equipped with a smart connected garment (with cardiovascular \& hemodynamic sensors), a connected weight balance and a blood pressure monitoring device for telemonitoring collection of cardiovascular hemodynamic parameters in real-life conditions (for 14 days).
Patients included in the registry will be followed-up for 3 years using medico-administrative databases and vital status, cardiovascular and heart failure outcomes will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFpEF patients | – | Other: Extensive phenotypingHeart failure patients (NYHA II-IV) with left ventricular ejection fraction ≥ 50%, 1000 patients anticipated among which up to 300 with extensive phenotyping |
| HFrEF patients | – | Other: Extensive phenotypingHeart failure patients (NYHA II-IV) with left ventricular ejection fraction ≤ 40%, 1000 patients anticipated among which up to 100 with extensive phenotyping (age- and gender-matched on participating HFpEF patients) |
| Subjects apparently without heart failure | – | Other: Extensive phenotypingSubjects without history or signs of heart failure, up to 100 subjects anticipated with extensive phenotyping (age- and gender-matched on participating HFpEF patients) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with different forms of heart failure (ie with preserved left ventricular ejection fraction vs. reduced left ventricular ejection fraction) and subjects apparently without heart failure
Key inclusion criteria (24 listed)
- All subjects
- Affiliation to a social security scheme, universal medical coverage (CMU) or any equivalent scheme
- Physical state compatible with the carrying out of the investigations according to the judgment of the investigator
- Procedure for obtaining consent
- Hospitalization in one of the partner hospitals in the last 30 months
Key exclusion criteria (27 listed)
- All subjects
- Pregnancy or breastfeeding
- Participation in another interventional study
- Person placed under the safeguard of justice
- Subject that can not understand the procedures related to the protocol
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 |
|---|---|---|
| Extensive phenotypingProspective assessment of physical evaluation, biomarkers and omics, cardiac and vascular imaging and telemonitoring of cardiovascular parameters for 14 days. | Other | HFpEF patients, HFrEF patients, Subjects apparently without heart failure |
Primary outcome
Machine learning algorithm to identify distinct phenotypic subgroups among HFpEF patients
Time frame: 14 days
Machine learning-based cluster analysis using extensive phenotyping data from HFpEF, HFrEF and subjects without apparent HF
23 secondary outcomes
Prognosis
Time frame: 3 years
Myocardial stiffness
Time frame: 3 years
Sarcopenia and muscular capacity
Time frame: 3 years
Exercise tolerance
Time frame: 3 years
Cardiac fibrosis
Time frame: 3 years
Arterial Stiffness
Time frame: 3 years
Right heart and pulmonary circulation
Time frame: 3 years
Ventricular-arterial coupling
Time frame: 3 years
Omics signature
Time frame: 3 years
Quality of life evaluation
Time frame: 3 years
Telemonitoring of weight
Time frame: 3 years
Telemonitoring of cardiac rythm
Time frame: 3 years
Telemonitoring of ECG
Time frame: 3 years
Telemonitoring of physical activity
Time frame: 3 years
Telemonitoring of blood pressure
Time frame: 3 years
Telemonitoring of pulmonary function
Time frame: 3 years
Telemonitoring of oxygen saturation
Time frame: 3 years
Telemonitoring of pulmonary congestion
Time frame: 3 years
Digitalized ECG
Time frame: 3 years
Cardiac echography
Time frame: 3 years
Cardiac calcium scoring
Time frame: 3 years
Cardiac MRI
Time frame: 3 years
Left atria
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 24491689Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
- BackgroundDe Peretti, et al. Prévalence et statut fonctionnel des cardiopathies ischémiques et de l'insuffisance cardiaque dans la population adulte en France : apports des enquêtes déclaratives " Handicap-Santé " BEH 2014; (9-10):172-81
- BackgroundGalinier M, et al. Parcours de Soins. Dossier insuffisance cardiaque, encore trop d'hospitalisations pourtant évitables. État des lieux en France en 2013. Le Concours Médical 2013; 135(6):443-7
- BackgroundLindenfeld J, Albert NM, Boehmer JP et coll. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010 ; 16 (6): e1-e194. - Arnold JM, Liu P, Demers C et coll. Canadian Cardiovascular Society consensus conference recommendations on heart failure 2006: diagnosis and management. Can J Cardiol 2006 ; 22 (1) : 23-45
- BackgroundBlanc - SVSE 1 - Physiologie, physiopathologie, santé publique (Blanc SVSE 1) 2013
- Background: PubMed 8790072Vasan RS, Levy D. The role of hypertension in the pathogenesis of heart failure. A clinical mechanistic overview. Arch Intern Med. 1996 Sep 9;156(16):1789-96.
- Background: PubMed 17707182Fonarow GC, Stough WG, Abraham WT, Albert NM, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007 Aug 21;50(8):768-77. doi: 10.1016/j.jacc.2007.04.064. Epub 2007 Aug 6.
- BackgroundCDC statistics 2016; AHA Heart disease and stoke statistics 2017; European CVD statistics 2017 ; Dunlay S et al 2017 Nat Rev Cardiol
- Background: PubMed 27207191Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
- Background: PubMed 22064591Zile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE; I-PRESERVE Investigators. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation. 2011 Dec 6;124(23):2491-501. doi: 10.1161/CIRCULATIONAHA.110.011031. Epub 2011 Nov 7.
- Background: PubMed 23810323Katz DH, Beussink L, Sauer AJ, Freed BH, Burke MA, Shah SJ. Prevalence, clinical characteristics, and outcomes associated with eccentric versus concentric left ventricular hypertrophy in heart failure with preserved ejection fraction. Am J Cardiol. 2013 Oct 15;112(8):1158-64. doi: 10.1016/j.amjcard.2013.05.061. Epub 2013 Jun 28.
- Background: PubMed 17404159Lam CS, Roger VL, Rodeheffer RJ, Bursi F, Borlaug BA, Ommen SR, Kass DA, Redfield MM. Cardiac structure and ventricular-vascular function in persons with heart failure and preserved ejection fraction from Olmsted County, Minnesota. Circulation. 2007 Apr 17;115(15):1982-90. doi: 10.1161/CIRCULATIONAHA.106.659763. Epub 2007 Apr 2.
- Individual participant dataSharing planned: Yes. Individual participant data used for publication could be shared through scientific collaboration with the sponsor or any collaborations implied.The sharing will respect the unital consortium agreement.
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Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Recruiting
Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction
Heart Failure
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
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.
Jean-Sébastien HULOT, MD PhD principal investigator
AP - HP, Hôpital Européen Georges-Pompidou, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and 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 24 inclusion and 27 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 28 Mar 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Machine learning algorithm to identify distinct phenotypic subgroups among HFpEF patients (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04189029, which also lists 30 linked publications.
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 28 Mar 2024.