Cohort of Heart Failure Patients

Not Applicable

Completed

• Conditions: Congestive Heart Failure
• Interventions: Other: Blood sampling and Quality of life questionnaire.

• Registration Number: NCT03422991
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-15
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-06
• Primary Completion: 2024-01-16
• Study Completion: 2024-01-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Congestive Heart Failure patients Cohort	Blood sampling and Quality of life questionnaire.	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Quality of life questionnaire : EuroQol (EQ-5D) at 12 months	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

Name	Time	Method
Renal function : glomerular filtration rate	2 months	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.
number of death (all-cause)	18 months
number of stroke	18 months
symptomatic hypotension	18 months
Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification	Baseline, 6, 12 and 18 months
cardiac assistance or heart transplantation	18 months
NT-proBNP	18 months	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
nonfatal myocardial infarction	18 months
Cardiac function	Baseline and 12 months	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
number ventricular arrhythmias	18 months	(ventricular tachycardia and ventricular fibrillation)
number of all cardiovascular cause death	18 months
number all unscheduled hospitalization for heart failure	18 months
number of dialysis	18 months

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hôpital Louis Pradel, Centre d'Investigation Clinique; 🇫🇷 Lyon, France