Cohort of Heart Failure Patients

NCT ID: NCT03422991

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2024-01-16

Brief Summary

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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

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Blood sampling and Quality of life questionnaire.

Intervention Type OTHER

Blood sampling and Quality of life questionnaire.

Interventions

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Blood sampling and Quality of life questionnaire.

Blood sampling and Quality of life questionnaire.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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69HCL17_0250

Identifier Type: -

Identifier Source: org_study_id

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