NCT06578520 Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
| NCT ID | NCT06578520 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fundación para la Investigación del Hospital Clínico de Valencia |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2024-07-30 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 31 participants in total. It began in 2024-07-30 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.
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. * 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.
Contact & Investigator
Marco Montomoli
PRINCIPAL INVESTIGATOR
Hospital Clínico Universitario de Valencia
Frequently Asked Questions
Who can join the NCT06578520 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06578520 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06578520 currently recruiting?
Yes, NCT06578520 is actively recruiting participants. Contact the research team at marcomontomoli@hotmail.it for enrollment information.
Where is the NCT06578520 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT06578520 clinical trial?
NCT06578520 is sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. The principal investigator is Marco Montomoli at Hospital Clínico Universitario de Valencia. The trial plans to enroll 31 participants.
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