Dapagliflozin on Volume Vascular Outcomes.

Sponsor
Frank Ruschitzka
Study ID
NCT04869124
Phase
PHASE4
Status
Completed

Conditions

  • Heart Failure，Congestive

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin propanediol (FORXIGA) tablet: 10 mg once daily p.o. on top of recommended standard therapy, duration of administration: 12 weeks.
  • Placebo — DRUG
    Placebo tablet, matching Dapagliflozin, once daily p.o. on top of recommended standard therapy, duration of administration: 12 weeks.

Study Details

The purpose of the DAPA-VOLVO trial is to investigate the effects of Dapagliflozin on top of recommended standard therapy on volume status and vascular function in clinically stable de novo or chronic heart failure patients after hospitalization because of an acute decompensated heart failure event.

Key Dates

Start date
Feb 15, 2021
Status verified
Nov 2024
Primary completion
Sep 26, 2024
Completion
Oct 28, 2024

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    Dapagliflozin tablet (10mg/tablet), orally, once daily for 12 weeks.
  • Placebo Comparator: Placebo
    Placebo tablet, matching Dapglilflozin, orally, once daily for 12 weeks.

Primary Outcome Measure

Change in relative plasma volume status (PVS). [ Time Frame: Change between baseline (0 weeks) and after 2, 6 and 12 weeks of treatment. ]

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