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

NCT06578520 | Recruiting Phase 4

• 1 other identifier: DAPA-DP
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 3rd (8th week) visit control compared with the 6th (20th week)visit control.

  To explore the effect of iSGLT2 in natriuresis and the peritoneal elimination of sodium in patients with CKD and refractory HF treated with peritoneal dialysis.

  Through study completion, an average of 4 months

Secondary Outcomes (9)

• Mean difference of the sum between the volume of diuresis in 24 hours and the daily peritoneal effluent ultrafiltration rate (ml/24hours) in the 3rd (8th week) visit control compared with the 6th (20th week) visit control.

  Through study completion, an average of 4 months

• Mean difference of the sum between the volume of diuresis in 24 hours and the daily peritoneal effluent ultrafiltration rate (ml/24hours) in the 2nd (4th week) visit control compared with the 5th (16th week) visit control.

  Through study completion, an average of 4 months

• Mean difference of the sum between 24-h natriuresis and the daily sodium elimination in the peritoneal effluent (mEq/L) in the 2nd visit control compared with the 5th visit control.

  Through study completion, an average of 4 months

• Mean difference between the hydration percentage: Total Body Water%, Extracellular Water% , Intracellular Water%, Plasma Fluid, Interstitial Fluid by bioimpedance in the 3rd visit control compared with the 6th visit control.

  Through study completion, an average of 4 months

• Collection of chemistry parameters: Mean change and standard deviations in Peritoneal Fluid Glucose Ratio and Sodium concentration in the effluent peritoneal dialysis fluid sample in the 3rd visit control compared with the 6th visit control.

  Through study completion, an average of 4 months

Other Outcomes (1)

• Collection of serious adverse events. The proportion of patients treated with DAPA presenting these adverse events, in comparison to the patients non-treated with DAPA, at the visit control 3rd, 6th and 8th.

  Through study completion, an average of 4 months

Study Arms (2)

Group 1

EXPERIMENTAL

They will receive standard of care plus Dapaglifozin for 8 weeks, after a 4-week wash out, they will receive receive standard of care for another 8 weeks.

Drug: Dapagliflozin

Group 2

EXPERIMENTAL

They will receive standard of care for 8 weeks, after a 4-week wash out, they will receive receive standard of care for another 8 weeks plus Dapaglifozin.

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

10 mg once per day, oral tablets

Also known as: Forxiga

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 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.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Marco Montomoli

  Hospital Clínico Universitario de Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Montomoli

CONTACT

961 973500; marcomontomoli@hotmail.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, open-label, crossover study, parallel, 2-sequence, 2-period, 2-treatment.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: July 30, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)