Current partner codePEPTIDESDE
NCT03422991·Not applicable·INTERVENTIONAL

Cohort of Heart Failure Patients

Status

Completed

Phase

Not applicable

Enrollment

150

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

OTHER

Blood sampling and Quality of life questionnaire.

Blood sampling and Quality of life questionnaire.

Timeline

From registration to results.

  1. First posted

    Feb 6, 2018

  2. Study start

    Dec 15, 2017

  3. Primary completion

    Jan 16, 2024

  4. Study completion

    Jan 16, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Nov 18, 2024

Outcomes

What the study measures.

Primary outcomes

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

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.

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.

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

number of death (all-cause)

Time frame · 18 months

number of all cardiovascular cause death

Time frame · 18 months

number all unscheduled hospitalization for heart failure

Time frame · 18 months

number of stroke

Time frame · 18 months

nonfatal myocardial infarction

Time frame · 18 months

cardiac assistance or heart transplantation

Time frame · 18 months

symptomatic hypotension

Time frame · 18 months

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

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

Lyon, France

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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