Dapagliflozin / Heart Failure · Phase 4 Trial

Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered but not-yet-reported phase IV crossover study examining dapagliflozin in refractory heart failure using natriuresis and peritoneal sodium elimination as primary outcomes over 20 weeks. No results are available in this registry record, so no evidence of efficacy or safety can be assessed.

What was studied

Phase 4, Interventional, Randomized, Crossover, Open label, Treatment purpose. Heart Failure; age from 18 Years. Intervention: Group 1; Group 2. Compared with: Not specified in registry record.. n = 31. 1 site: Spain.

Key findings

Safety

This is a registry record only; no results are reported, so efficacy, safety, or clinical benefit cannot be determined.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record with no results posted; it describes a planned phase IV crossover study in a small single-centre population with a surrogate renal endpoint, not yet reported.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 3rd (8th week) visit control compared with the 6th (… (assessed at Through study completion, an average of 4 months)

DesignPhase 4, Interventional, Randomized, Crossover, Open label, Treatment purpose

PopulationHeart Failure; age from 18 Years

Sample size31

InterventionGroup 1; Group 2

ComparatorNot specified in registry record.

Setting1 site: Spain

Reported figures

Quoted from the source exactly as published.

Planned enrollment31

PhasePhase 4

Study durationaverage of 4 months

Primary outcome measureMean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) at 8th week versus 20th week

Caveats

This is a registry record only; no results are reported, so efficacy, safety, or clinical benefit cannot be determined.
Open-label design without blinding of participants or assessors.
Primary outcome is a surrogate physiological measure (natriuresis and sodium elimination), not a clinical heart failure endpoint.
Small sample size (31 participants) and single-centre design limit generalizability.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Crossover design with randomization; open-label; phase IV; single-centre.

Directness

limited

Primary outcome is natriuresis and sodium elimination, a physiological surrogate, not clinical heart failure outcome.

Consistency

insufficient

Registry record only; no results reported, so consistency cannot be assessed.

Risk of bias

limited

Open-label design introduces detection bias; no blinding of participants or assessors.

Sample adequacy

limited

Actual enrollment 31 participants; small sample size limits statistical power.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06578520). This is a study registration, not published results. Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 31 participants (ACTUAL). Conditions: Heart Failure. Interventions: DRUG: Dapagliflozin. Primary outcome measures: Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 3rd (8th week) visit control compared with the 6th (20th week)visit control. , Through study completion, an average of 4 months. Brief summary: Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

DapagliflozinFundación para la Investigación del Hospital Clínico de ValenciaHeart FailureNCT06578520