Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
Recruiting
Phase 4Interventional Study
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
31 (estimated)
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia · Other
Who this trial is looking for
This trial is looking for adults with heart failure who are currently undergoing peritoneal dialysis. Participants will take the medication dapagliflozin and be monitored over a set period.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetes
You may be able to join if
I am at least 18 years old.
I have been diagnosed with heart failure.
I am currently undergoing peritoneal dialysis.
I have chronic kidney disease.
I have been stable on heart failure treatment for at least a month.
I have had no hospitalizations for heart failure in the past month.
I have been on stable doses of diuretics for 14 days.
You may not be able to join if
I have a life expectancy of less than 1 year.
I have had recent serious health issues like a heart attack or stroke.
I am currently pregnant or breastfeeding.
I have type 1 diabetes.
I have had major heart surgery in the last month.
I cannot follow the study's rules and procedures.
I am allergic to dapagliflozin.
I have participated in another clinical trial in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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.
* Indi…
Inclusion Criteria:
* 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).
* In treatment with Peritoneal Dialysis technique
* Chronic Kidney Disease (eGFR \< 60 ml/min/m2 CKD-EPI formula)
* PD vintage of more than 30 days
* On stable doses of furosemide, or alternative loop diuretic for 14 days
* On stable HF therapy for at least 1 month prior to consent
* No hospitalizations for HF for at least 1 month prior to consent
Exclusion Criteria:
* 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
* Rejection or revocation of informed consent
* Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 1 month prior to enrollment.
* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement) within 1 month prior to enrollment or planned to undergo any of these operations after randomization.
* Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 1 month prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT or ICD device.
* Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization
* Pregnant or breast-feeding women
* Type 1 Diabetes
* Residual urine volume less than 500ml daily or reduction in urinary output by 24 hours (\< 30% compared to previous routine control) within 30 days prior to consent
* Patients with amputated limbs will be excluded of bioimpedance analysis.
* Participation in another clinical study with an investigational product during the last 3 months.
* Patients with a known hypersensitivity to Dapagliflozin or any of the excipients of the product.
* Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
* Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
* Previous enrolment in the present study.
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