PACIFIC-PRESERVED : PhenomApping, ClassIFication, and Innovation for Cardiac Dysfunction - HF With PRESERVED LVEF Study

NCT04189029 | Active Not Recruiting

• 2 other identifiers: APHP1905582019-A01795-52
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Heart Failure; Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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

  14 days

Secondary Outcomes (23)

• Prognosis

  3 years

• Myocardial stiffness

  3 years

• Sarcopenia and muscular capacity

  3 years

• Exercise tolerance

  3 years

• Cardiac fibrosis

  3 years

Study Arms (3)

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

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)

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)

Other: Extensive phenotyping

Interventions

Extensive phenotyping OTHER

Prospective assessment of physical evaluation, biomarkers and omics, cardiac and vascular imaging and telemonitoring of cardiovascular parameters for 14 days.

HFpEF patients; HFrEF patients; Subjects apparently without heart failure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• BPIfrance: collaborator
• Sanofi: collaborator
• Institut de Recherches Internationales Servier: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• BioSerenity: collaborator
• Casis: collaborator
• Firalis SA: collaborator
• Fealinx: collaborator
• Centre National de la Recherche Scientifique, France: collaborator
• ESPCI Paris: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• Sorbonne University: collaborator

Study Sites (1)

AP - HP, Hôpital Européen Georges-Pompidou

Paris, France

Location

Related Publications (30)

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Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, PaxGene RNA, PBMC

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jean-Sébastien HULOT, MD PhD

  AP - HP, Hôpital Européen Georges-Pompidou, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 6, 2019
• Study Start: December 9, 2019
• Primary Completion: December 9, 2023
• Study Completion: December 1, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Will become available from the time when summary data are published
• Access Criteria: Sharing access criteria will be discussed between the sponsor and collaborate

Locations

FR (1)