Effect of the Use of Dapagliflozin in Diuresis, Natriuriesis and in Ultrafiltration and Peritoneal Elimination of Sodium, in Patients with Refractory Heart Failure (Dapa-Dp Study)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

16 May 2024 → ongoing

Decision date (initial)

2023-09-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety

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.

Conditions and MedDRA coding

REFRACTORY HEART FAILURE

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. 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. 2. Provision of informed consent form prior to any study specific procedures, sampling and analysis. 3. Individuals must be ≥ 18 years of age at the time of signing the informed consent 4. Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF). 5. In treatment with Peritoneal Dialysis technique 6. Chronic Kidney Disease (eGFR < 60 ml/min/m2 CKD-EPI formula) 7. PD vintage of more than 30 days 8. On stable doses of furosemide, or alternative loop diuretic for 14 days 9. On stable HF therapy for at least 1 month prior to consent 10. No hospitalizations for HF for at least 1 month prior to consent

Exclusion criteria 1

1. 1. Limited life expectancy (less than 1 year) based on investigator’s clinical judgement. 2. Patients without indication of beginning treatment with Dapagliflozin according to the Data Sheets and Consumer Medicine Information. 3. Malignancy (with active treatment) or other life-threatening disease 4. Patients in whom proper study compliance cannot be guaranteed 5. Rejection or revocation of informed consent 6. Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 1 month prior to enrollment. 7. 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. 8. 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. 9. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization 10. Pregnant or breast-feeding women 11. Type 1 Diabetes 12. 9. 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 13. Patients with amputated limbs will be excluded of bioimpedance analysis. 14. Participation in another clinical study with an investigational product during the last 3 months. 15. Patients with a known hypersensitivity to Dapagliflozin or any of the excipients of the product. 16. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site). 17. 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. 18. Previous enrolment in the present study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. For the primary endpoint, we assume a mean sum between the natriuresis in 24 hours and the daily peritoneal dialytic sodium removal of 122 mEq. Treatment is estimated to increase values by an average of 15% to 140 mEq after treatment. Standard deviation from pretreatment and post treatment is 30 mEq. Assuming a two-sided paired t-test with alfa error of 0.05, power of 80% correlation between pre-post treatment of 0.7 and drop-out rate of 25%, the total sample size required is 30 patients.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA

Sponsor organisation

Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA

Address

Avenida Menendez Y Pelayo 4 Acc

City

Valencia

Postcode

46010

Country

Spain

Scientific contact point

Organisation

Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA

Contact name

UICEC

Public contact point

Organisation

Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA

Contact name

UICEC

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications