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NCT03422991Completed

Cohort of Heart Failure Patients

Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure

Source: ClinicalTrials.gov · Last updated 18 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
150 (actual)
First submitted
12 Jan 2018
Start date
15 Dec 2017
Primary completion date
16 Jan 2024
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT03422991

What you commit to

  • Study type: Interventional
  • Participants enrolled: 150
  • From 15 Dec 2017 to the primary completion date, 16 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients on long term assistance or with heart transplant
  • Loss of autonomy, dementia, major dependence

Other

  • Life expectancy shorter than a month
  • Impossibility to give patients clear information
  • Patients without health coverage
  • Patient with no legal protection
  • Pregnant woman

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospices Civils de Lyon - Hôpital Louis Pradel, Centre d'Investigation Clinique
Coordinator of this site? Confirm its status
LyonFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.