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Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE) (AHF-CORE)

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ClinicalTrials.gov Identifier: NCT03327532
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

The AHF-CORE study is a prospective, non-randomized, multicenter regional study.

The main objective of the AHF-CORE study is to identify congestion markers (clinical, biological and ultrasound) at the beginning and at the end of hospitalization for acute heart failure that are more strongly associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.

Secondary objectives are:

  • Quantify the variations in congestion markers between the beginning and end of hospitalization for acute heart failure.
  • Assess the correlation between changes in congestion markers between the beginning and end of hospitalization.
  • Identify the congestion markers at the beginning of hospitalization that are most strongly associated with residual congestion at the end of hospitalization.
  • Identify the added value of ultrasound and biological markers of congestion in addition to clinical variables for the prediction of all-cause death or hospitalization for acute heart failure at 3 months after hospital discharge.

Condition or disease Intervention/treatment Phase
Acute Heart Failure Procedure: Clinical examination centered on congestion Procedure: Cardio-pulmonary and peritoneal ultrasound Biological: Blood sample retrieved for biological assessment and biobanking Other: Telephone interview Not Applicable

Detailed Description:

Congestion (clinical, biological and ultrasound evaluation) will be quantified at inclusion within 72 hours of admission and before hospital discharge.

Follow-up at 3 months of hospital discharge will be performed through telephone interviews. Vital status and rehospitalization status will be collected.

Throughout the study, patients will continue to be treated according to usual routine care, regardless of their level of congestion. There will be no modification of treatment according to the congestion data acquired within the setting of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d'Une Hospitalisation Pour Insuffisance Cardiaque aigüe
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Patients hospitalized for acute heart failure

One arm study.

Patients hospitalized for acute heart failure will undergo the following evaluations:

  • Clinical examination centered on congestion
  • Cardiopulmonary and peritoneal ultrasound
  • Blood sample retrieved for biological assessment and biobanking
  • Telephone interview
Procedure: Clinical examination centered on congestion
Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital

Procedure: Cardio-pulmonary and peritoneal ultrasound
Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital

Biological: Blood sample retrieved for biological assessment and biobanking
Blood sample collection will be performed within 72 hours of admission and before discharge from hospital

Other: Telephone interview
Telephone interview will be performed 3 months after discharge from hospital




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: at 3 months after hospital discharge ]
    composite criteria

  2. Rehospitalization for acute heart failure [ Time Frame: at 3 months after hospital discharge ]
    composite criteria


Secondary Outcome Measures :
  1. Clinical congestion markers [ Time Frame: at admission and at final discharge (an average of 10 days after admission) ]
    Ambrosy score : rales, jugular vein pressure, edema, fatigue, dyspnea, orthopnea

  2. Biological congestion markers [ Time Frame: at admission and at final discharge (an average of 10 days after admission) ]
    BNP, Hemoglobin, Hematocrit

  3. Ultrasound congestion markers [ Time Frame: at admission and at final discharge (an average of 10 days after admission) ]
    B lines, pleural effusion, E/e', DTE, TRV, VCI, Jugular diameter, renal venous blood flow pattern, peritoneal effusion

  4. Residual congestion [ Time Frame: at final discharge (an average of 10 days after admission) ]
    as defined as an Ambrosy score 3 or more and/or B-lines score 30 or more and/or an IVC>21 and IVC collapse with sniff <50%



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients hospitalized for left-sided or global acute heart failure due to exacerbation of chronic heart failure within 72 hours of admission to hospital
  • Patients over 60 years old
  • Person affiliated to or beneficiary of a social security plan
  • Person informed about study organization and having signed the informed consent

Exclusion Criteria:

  • Comorbidity for which life expectancy is ≤ 3 months
  • Diagnosis of heart failure made less than 3 months prior to inclusion
  • Exacerbation of heart failure attributed to acute ischemic stroke (acute coronary syndrome with or without ST segment elevation)
  • Dialyzed patient (peritoneal dialysis or hemodialysis) and patients with glomerular filtration rate <15 ml / min / m2 at baseline
  • History of pulmonary lobectomy or pneumonectomy
  • Severe pulmonary or pleural disease preventing the reliable acquisition of pulmonary ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis
  • Woman of childbearing age without effective contraception
  • Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the French Public Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of public guardianship) ; Adult person incapable of giving consent and not under legal protection.
  • Persons deprived of liberty for judicial or administrative decision
  • Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327532


Contacts
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Contact: Nicolas GIRERD, MD,PhD + 33 3 83 15 74 96 ext + 33 3 n.girerd@chru-nancy.fr

Locations
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France
CHR Metz-Thionville - Hôpital de Mercy Not yet recruiting
Metz, Lorraine, France, 57000
Principal Investigator: Noura ZANNAD, MD         
CHRU Nancy Hôpitaux de Brabois Recruiting
Vandœuvre-lès-Nancy, Lorraine, France, 54500
Principal Investigator: Nicolas GIRERD, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Nicolas GIRERD, MD,PhD Centre d'Investigation Clinique 1433 module Plurithématique de Nancy

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03327532     History of Changes
Other Study ID Numbers: 2017-A01455-48
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Acute Heart Failure
Congestion
Ultrasound
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases