CHRONIC DECOMPENSATED HEART FAILURE
Conditions
Brief summary
Organizational feasibility: setting up procedures, distribution of subjects in the flow chart. Acceptability based on refusal characteristics: number and reason. Adherence to the protocol and treatment: attrition, completeness of emergency CRF and IPA completion, proportion of patients contacted by telephone, compliance with the treatment and follow-up regimen. Compliance with the provisional timeline for the implementation of the study
Detailed description
A composite endpoint comprising the following at 3 months: - All-cause mortality - Rehospitalization or unplanned visit for CHF - Deterioration in quality of life: 5-point decrease after 3 months of treatment compared to the value measured at hospital discharge (KCCQ-12), Each of the three criteria of the composite criterion taken individually, A 50% decrease in NT-proBNP levels at 7 days (or upon discharge from hospital if earlier than 7 days) and at 3 months, Regression of clinical signs (dyspnea, asthenia, congestive signs) at 7 days (or upon discharge from hospital if earlier than 7 days) and at 3 months, Tolerance in relation to renal function: difference between glomerular filtration rate relative to baseline (at randomization) at 7 days (or at hospital discharge if earlier than 7 days) and at 3 months.
Interventions
DRUGDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
Sponsors
Centre Hospitalier Regional Universitaire
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Organizational feasibility: setting up procedures, distribution of subjects in the flow chart. Acceptability based on refusal characteristics: number and reason. Adherence to the protocol and treatment: attrition, completeness of emergency CRF and IPA completion, proportion of patients contacted by telephone, compliance with the treatment and follow-up regimen. Compliance with the provisional timeline for the implementation of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| A composite endpoint comprising the following at 3 months: - All-cause mortality - Rehospitalization or unplanned visit for CHF - Deterioration in quality of life: 5-point decrease after 3 months of treatment compared to the value measured at hospital discharge (KCCQ-12), Each of the three criteria of the composite criterion taken individually, A 50% decrease in NT-proBNP levels at 7 days (or upon discharge from hospital if earlier than 7 days) and at 3 months, Regression of clinical signs (dyspnea, asthenia, congestive signs) at 7 days (or upon discharge from hospital if earlier than 7 days) and at 3 months, Tolerance in relation to renal function: difference between glomerular filtration rate relative to baseline (at randomization) at 7 days (or at hospital discharge if earlier than 7 days) and at 3 months. | — |
Outcome results
None listed