Cohort of Heart Failure Patients

NCT03422991 | Completed

• 1 other identifier: 69HCL17_0250
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

Heart Failure; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cohort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Renal function : glomerular filtration rate

  Baseline

• Renal function : glomerular filtration rate

  2 months

• NT-proBNP

  18 months

• number of death (all-cause)

  18 months

• number of all cardiovascular cause death

  18 months

Study Arms (1)

Congestive Heart Failure patients Cohort

OTHER

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.

Interventions

Blood sampling and Quality of life questionnaire. OTHER

Blood sampling and Quality of life questionnaire.

Congestive Heart Failure patients Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Lyon, France

Location

MeSH Terms

Conditions

Heart Failure; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 6, 2018
• Study Start: December 15, 2017
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)