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Cohort of Heart Failure Patients (LOOP-HF)

Primary Purpose

Congestive Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling and Quality of life questionnaire.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Congestive Heart Failure focused on measuring Heart Failure, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Cohort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with congestive heart failure confirmed during

    • Hospitalization for cardiac decompensation
    • A medical follow-up for stable congestive heart failure with at least one cardiac decompensation event
  • NT-proBNP > 500 ng/l in the month before Baseline (or BNP > 150 ng/l)
  • NYHA ≥ 2
  • Aged over 18
  • Signature of the informed consent

Exclusion Criteria:

  • Life expectancy shorter than a month
  • Patients on long term assistance or with heart transplant
  • Impossibility to give patients clear information
  • Loss of autonomy, dementia, major dependence
  • Patients without health coverage
  • Patient with no legal protection
  • Pregnant woman

Sites / Locations

  • Hospices Civils de Lyon - Hôpital Louis Pradel, Centre d'Investigation CliniqueRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Congestive Heart Failure patients Cohort

Arm Description

Cluster of patients with congestive heart failure NYHA ≥2, with at least one cardiac decompensation, NT-proBNP (N-terminal pro-brain natriuretic peptide) > 500 ng/l. Will be followed during 18 months.

Outcomes

Primary Outcome Measures

Change from Baseline Quality of life questionnaire : EuroQol (EQ-5D) at 12 months
Measurement of quality of life of patients with heart failure: patient will answer to this questionnaire (Mobility, Autonomy of the person, Current activities, Pain ,Anxiéty/Depression) ) at baseline and at 12th month visit. The evolution between these two scores will be analysed .

Secondary Outcome Measures

Renal function : glomerular filtration rate
Assessing the renal function evolution of patients with heart failure the glomerular filtration rate will be calculated according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) formula.
Renal function : glomerular filtration rate
Assessing the renal function evolution of patients with heart failure the glomerular filtration rate will be calculated according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) formula.
NT-proBNP
Measure of NT-proBNP will be done at 18th month in order to correlate the effect of low blood pression and renal function decreasing on NT-proBNP variability
number of death (all-cause)
number of all cardiovascular cause death
number all unscheduled hospitalization for heart failure
number of stroke
nonfatal myocardial infarction
cardiac assistance or heart transplantation
symptomatic hypotension
number of dialysis
number ventricular arrhythmias
(ventricular tachycardia and ventricular fibrillation)
Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification
Cardiac function
Cardiac function will be evaluated on Echography Trans Thoracic at baseline and at the 12 months visit. Left Ventricular Ejection Fraction levitation pressure filling (yes/No) Right ventricular dysfunction (yes/no) pulmonary artery systolic pressure (mmHg) right atrial pressure

Full Information

First Posted
January 12, 2018
Last Updated
October 21, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03422991
Brief Title
Cohort of Heart Failure Patients
Acronym
LOOP-HF
Official Title
Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective cohort study of patients with Heart Failure with an eighteen-month follow-up aimed to collect all demographic, clinical, biological and para-clinical data to study population characteristics, assess prognosis markers and occurrence of HF treatment side effects. Congestive Heart failure is a frequent pathology and its prevalence increases with age. Its prognosis stays pejorative despite years of major therapeutical progress. In recent trials, all-cause mortality rates at 1-year reach up to 20% and 50% at 5 years. Medical care of congestive heart failure is based on precise international recommendations. The association of Beta-Blockers, renin-angiotensin system blockers, mineralocorticoid receptor antagonists, represent the basis of the pharmacological treatment. Cardiac resynchronization treatment and implantable cardioverter-defibrillator are additional efficient treatments that reduce events in appropriately selected patients. Despite these improvements, the prognostic of congestive heart failure in registers is worse than those observed in randomized trials. This can be explained by differences in congestive heart failure patient populations and/or by a less rigorous medical care where treatments are not optimized. The evaluation of medical care in congestive heart failure is today of utmost importance. Integrating new pharmacological molecules, medical devices and the application of new recommendations have major interest for documentation and practical changes. The main objective of this cohort will be to evaluate the evolution of the 12-month quality of life score of a HF patient and the characteristics and treatments associated with it.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Heart Failure, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Cohort

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Congestive Heart Failure patients Cohort
Arm Type
Other
Arm Description
Cluster of patients with congestive heart failure NYHA ≥2, with at least one cardiac decompensation, NT-proBNP (N-terminal pro-brain natriuretic peptide) > 500 ng/l. Will be followed during 18 months.
Intervention Type
Other
Intervention Name(s)
Blood sampling and Quality of life questionnaire.
Intervention Description
Blood sampling and Quality of life questionnaire.
Primary Outcome Measure Information:
Title
Change from Baseline Quality of life questionnaire : EuroQol (EQ-5D) at 12 months
Description
Measurement of quality of life of patients with heart failure: patient will answer to this questionnaire (Mobility, Autonomy of the person, Current activities, Pain ,Anxiéty/Depression) ) at baseline and at 12th month visit. The evolution between these two scores will be analysed .
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Renal function : glomerular filtration rate
Description
Assessing the renal function evolution of patients with heart failure the glomerular filtration rate will be calculated according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) formula.
Time Frame
Baseline
Title
Renal function : glomerular filtration rate
Description
Assessing the renal function evolution of patients with heart failure the glomerular filtration rate will be calculated according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) formula.
Time Frame
2 months
Title
NT-proBNP
Description
Measure of NT-proBNP will be done at 18th month in order to correlate the effect of low blood pression and renal function decreasing on NT-proBNP variability
Time Frame
18 months
Title
number of death (all-cause)
Time Frame
18 months
Title
number of all cardiovascular cause death
Time Frame
18 months
Title
number all unscheduled hospitalization for heart failure
Time Frame
18 months
Title
number of stroke
Time Frame
18 months
Title
nonfatal myocardial infarction
Time Frame
18 months
Title
cardiac assistance or heart transplantation
Time Frame
18 months
Title
symptomatic hypotension
Time Frame
18 months
Title
number of dialysis
Time Frame
18 months
Title
number ventricular arrhythmias
Description
(ventricular tachycardia and ventricular fibrillation)
Time Frame
18 months
Title
Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification
Time Frame
Baseline, 6, 12 and 18 months
Title
Cardiac function
Description
Cardiac function will be evaluated on Echography Trans Thoracic at baseline and at the 12 months visit. Left Ventricular Ejection Fraction levitation pressure filling (yes/No) Right ventricular dysfunction (yes/no) pulmonary artery systolic pressure (mmHg) right atrial pressure
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with congestive heart failure confirmed during Hospitalization for cardiac decompensation A medical follow-up for stable congestive heart failure with at least one cardiac decompensation event NT-proBNP > 500 ng/l in the month before Baseline (or BNP > 150 ng/l) NYHA ≥ 2 Aged over 18 Signature of the informed consent Exclusion Criteria: Life expectancy shorter than a month Patients on long term assistance or with heart transplant Impossibility to give patients clear information Loss of autonomy, dementia, major dependence Patients without health coverage Patient with no legal protection Pregnant woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan MEWTON, M.D
Phone
4 72 35 71 70
Ext
00 33
Email
nathan.mewton@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Claire JOSSAN
Phone
4 27 85 66 90
Ext
00 33
Email
claire.jossan@chu-lyon.fr
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital Louis Pradel, Centre d'Investigation Clinique
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Mewton
Phone
4 72 35 71 70
Ext
00 33
Email
nathan.mewton@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Claire Jossan
Phone
4 27 85 66 90
Ext
00 33
Email
claire.jossan@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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