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

Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Study ID
NCT06578520
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.

Key Dates

Start date
Jul 30, 2024
Status verified
Aug 2025
Primary completion
Dec 1, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
31 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    They will receive standard of care plus Dapaglifozin for 8 weeks, after a 4-week wash out, they will receive receive standard of care for another 8 weeks.
  • Experimental: Group 2
    They will receive standard of care for 8 weeks, after a 4-week wash out, they will receive receive standard of care for another 8 weeks plus Dapaglifozin.

Primary 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 (20th week)visit control. [ Time Frame: Through study completion, an average of 4 months ]

Central Contacts

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