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EFFECT OF THE USE OF DAPAGLIFLOZIN IN DIURESIS, NATRIURIESIS AND IN ULTRAFILTRATION AND PERITONEAL ELIMINATION OF SODIUM, IN PATIENTS WITH REFRACTORY HEART FAILURE (DAPA-DP study)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505571-78-00
Enrollment
1
Registered
2023-09-01
Start date
2024-05-16
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

REFRACTORY HEART FAILURE

Brief summary

For the primary endpoint, we assume a mean sum between the natriuresis in 24 hours and the daily peritoneal dialytic sodium removal of 122 mEq. Treatment is estimated to increase values by an average of 15% to 140 mEq after treatment. Standard deviation from pretreatment and post treatment is 30 mEq. Assuming a two-sided paired t-test with alfa error of 0.05, power of 80% correlation between pre-post treatment of 0.7 and drop-out rate of 25%, the total sample size required is 30 patients.

Interventions

DRUGForxiga 10 mg film-coated tablets

Sponsors

Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
For the primary endpoint, we assume a mean sum between the natriuresis in 24 hours and the daily peritoneal dialytic sodium removal of 122 mEq. Treatment is estimated to increase values by an average of 15% to 140 mEq after treatment. Standard deviation from pretreatment and post treatment is 30 mEq. Assuming a two-sided paired t-test with alfa error of 0.05, power of 80% correlation between pre-post treatment of 0.7 and drop-out rate of 25%, the total sample size required is 30 patients.—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026