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Cohort of Heart Failure Patients (LOOP-HF)

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ClinicalTrials.gov Identifier: NCT03422991
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Congestive Heart Failure Other: Blood sampling and Quality of life questionnaire. Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.
Other: Blood sampling and Quality of life questionnaire.
Blood sampling and Quality of life questionnaire.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422991


Contacts
Contact: Nathan MEWTON, M.D 4 72 35 71 70 ext 00 33 nathan.mewton@chu-lyon.fr
Contact: Claire JOSSAN 4 27 85 66 90 ext 00 33 claire.jossan@chu-lyon.fr

Locations
France
Hospices Civils de Lyon - Hôpital Louis Pradel, Centre d'Investigation Clinique Recruiting
Lyon, France
Contact: Nathan Mewton    4 72 35 71 70 ext 00 33    nathan.mewton@chu-lyon.fr   
Contact: Claire Jossan    4 27 85 66 90 ext 00 33    claire.jossan@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03422991     History of Changes
Other Study ID Numbers: 69HCL17_0250
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cohort

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases