BridgeMD
New treatment option for Heart Failure
Official title Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
ClinicalTrials.gov ID: NCT06578520
What this study is testing
What is Dapagliflozin?
Dapagliflozin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for heart failure.
Also referred to as Forxiga.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
- 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...
- In treatment with Peritoneal Dialysis technique
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Valencia, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.