Informations générales (source: ClinicalTrials.gov)
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)
Observational [Patient Registry]
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2019
décembre 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | HULOT Jean-sebastien | 18/04/2025 07:55:20 | Contacter | ||
| AP-HP - Hôpital Europeen Georges Pompidou | HULOT Jean-sebastien | 18/04/2025 07:55:20 | Contacter | ||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | HULOT Jean-sebastien | 18/04/2025 07:55:20 | Contacter | ||
| AP-HP - Hôpital La Pitié-Salpêtrière | HULOT Jean-sebastien | 18/04/2025 07:55:20 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | HULOT Jean-sebastien | 18/04/2025 07:55:20 | Contacter | ||
| AP-HP - Hôpital Saint Antoine | HULOT Jean-sebastien | 18/04/2025 07:55:20 | Contacter | ||
Critères
Tous
Inclusion Criteria:
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
- 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)
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
- 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)
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)
- 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