Clinical trial NCT03422991: Cohort of Heart Failure Patients
Official title: Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Heart Failure
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cohort
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Quality of life questionnaire : EuroQol (EQ-5D) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Renal function : glomerular filtration rate
timeFrame: Baseline
measure: Renal function : glomerular filtration rate
timeFrame: 2 months
measure: NT-proBNP
timeFrame: 18 months
measure: number of death (all-cause)
timeFrame: 18 months
measure: number of all cardiovascular cause death
timeFrame: 18 months
measure: number all unscheduled hospitalization for heart failure
timeFrame: 18 months
measure: number of stroke
timeFrame: 18 months
measure: nonfatal myocardial infarction
timeFrame: 18 months
measure: cardiac assistance or heart transplantation
timeFrame: 18 months
measure: symptomatic hypotension
timeFrame: 18 months
measure: number of dialysis
timeFrame: 18 months
measure: number ventricular arrhythmias
timeFrame: 18 months
measure: Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification
timeFrame: Baseline, 6, 12 and 18 months
measure: Cardiac function
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital Louis Pradel, Centre d'Investigation Clinique
Study officials:
References: