Cohort of Heart Failure Patients (LOOP-HF)

Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Other: Blood sampling and Quality of life questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Congestive Heart Failure patients Cohort; 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.	Other: Blood sampling and Quality of life questionnaire.; Blood sampling and Quality of life questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	2 months
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	18 months
number of death (all-cause)		18 months
number of all cardiovascular cause death		18 months
number all unscheduled hospitalization for heart failure		18 months
number of stroke		18 months
nonfatal myocardial infarction		18 months
cardiac assistance or heart transplantation		18 months
symptomatic hypotension		18 months
number of dialysis		18 months
number ventricular arrhythmias	(ventricular tachycardia and ventricular fibrillation)	18 months
Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification		Baseline, 6, 12 and 18 months
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	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): January 16, 2024
• Study Completion (Actual): January 16, 2024

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Vascular Diseases; Cardiovascular Diseases; Cohort; Heart Diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 69HCL17_0250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No