Cohort of Heart Failure Patients (LOOP-HF)

Civil Hospices of Lyon

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Other: Blood sampling and Quality of life questionnaire.

Study type: Interventional

Funder types: Other

Identifiers

NCT03422991

69HCL17_0250

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Congestive Heart Failure patients Cohort

Other group

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.

Treatment:

Other: Blood sampling and Quality of life questionnaire.