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

ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación para la Investigación del Hospital Clínico de Valencia

About this trial

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

Eligibility criteria

Qualifiers

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Provision of informed consent form prior to any study specific procedures, sampling and analysis.

Individuals must be ≥ 18 years of age at the time of signing the informed consent

Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).

Disqualifiers

Limited life expectancy (less than 1 year) based on investigator's clinical judgement.

Patients without indication of beginning treatment with Dapagliflozin according to the Data Sheets and Consumer Medicine Information.

Malignancy (with active treatment) or other life-threatening disease

Patients in whom proper study compliance cannot be guaranteed

Trial design

Treatments tested in this trial

  • Dapagliflozin

Treatment groups

31 Participants
are divided into 2 treatment groups