Cohort of Heart Failure Patients

Congestive Heart Failure Clinical Trial

— LOOP-HF  

Official title:

Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03422991
• Other study ID #: 69HCL17_0250
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: June 2023

Study information

• Verified date: October 2019
• Source: Hospices Civils de Lyon
• Contact: Nathan MEWTON, M.D
• Phone: 4 72 35 71 70
• Email: nathan.mewton[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Louis Pradel, Centre d'Investigation Clinique	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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