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Completed

NCT Number: NCT03422991

Cohort of Heart Failure Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling and Quality of life questionnaire.

Other

Blood sampling and Quality of life questionnaire.

Primary outcomes

  1. Change from Baseline Quality of life questionnaire : EuroQol (EQ-5D) at 12 months

    Time frame: 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 .

Secondary outcomes

  1. Renal function : glomerular filtration rate

    Time frame: Baseline

    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. Renal function : glomerular filtration rate

    Time frame: 2 months

    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.

  3. NT-proBNP

    Time frame: 18 months

    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

  4. number of death (all-cause)

    Time frame: 18 months

  5. number of all cardiovascular cause death

    Time frame: 18 months

  6. number all unscheduled hospitalization for heart failure

    Time frame: 18 months

  7. number of stroke

    Time frame: 18 months

  8. nonfatal myocardial infarction

    Time frame: 18 months

  9. cardiac assistance or heart transplantation

    Time frame: 18 months

  10. symptomatic hypotension

    Time frame: 18 months

  11. number of dialysis

    Time frame: 18 months

  12. number ventricular arrhythmias

    Time frame: 18 months

    (ventricular tachycardia and ventricular fibrillation)

  13. Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification

    Time frame: Baseline, 6, 12 and 18 months

  14. Cardiac function

    Time frame: Baseline and 12 months

    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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure

Acronym: LOOP-HF

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2018
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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