Sodium-glucose Cotransporter Type 2 Inhibitors for Acute Cardiorenal Syndrome Prevention

NCT04778787 | Completed Phase 4 DMC

• 1 other identifier: 10773100889666
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 2

Brief Summary

The effect of sodium-glucose cotransporter type 2 inhibitors (SGLT2i) on the parameters of renal function in acute decompensation of chronic heart failure (ADHF) compared to standard therapy will be analyzed. Based on the dynamics of the clinical condition, the duration of hospitalization, and blood biochemical parameters (creatinine, urea, uric acid, potassium, sodium, N-terminal pro-brain natriuretic peptide - NT-proBNP) conclusions will be drawn about the possibility of using SGLT2i in this group of patients.

Conditions

Congestive Heart Failure

Keywords

heart failure; decompensation; gliflozins; kidneys

Outcome Measures

Primary Outcomes (1)

• death due to heart failure

  Death during hospitalization

  through study completion, an average of 5 days

Secondary Outcomes (3)

• deterioration of renal function (increase in blood creatinine by 0.3 mg / dl within 48 hours)

  through study completion, an average of 5 days

• development of resistance to diuretics

  through study completion, an average of 5 days

• re-hospitalization about decompensation of chronic heart failure within 30 days after discharge from the hospital

  up to 30 days

Other Outcomes (2)

• weight loss during hospitalization

  through study completion, an average of 5 days

• admission to the intensive care unit due to worsening heart failure during the current hospitalization

  through study completion, an average of 5 days

Study Arms (2)

the intervention group

EXPERIMENTAL

The intervention group includes patients with decompensated chronic heart failure. The diagnosis will be made according to the criteria described above

Drug: Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596)

the control group

EXPERIMENTAL

The control group will be identical to the main group.

Drug: Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596)

Interventions

Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596) DRUG

Patients will receive dapagliflozin at a dose of 10 mg daily during hospitalization in addition to ongoing therapy

the control group; the intervention group

Eligibility Criteria

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

You may qualify if:

• \. Diagnosed ADHF (based on 1) presence of congestion (based on the presence of dyspnoea and at least two of the following:congestion on chest X-ray, rales on chest auscultation, peripheral edema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) 2) the need for intravenous administration of loop diuretics.

You may not qualify if:

• Cardiogenic shock (systolic blood pressure \<90 mm Hg; signs of hypoperfusion (altered mental status, cold skin, diuresis \<30 ml / hour, blood lactate level \>2.0 mmol / l).
• Urinary tract infection
• Type 1 diabetes mellitus (DM1), episodes of diabetic ketoacidosis or hypoglycemia
• Prior use of drugs from the SGLT2i group, taken regularly within 4 weeks
• GFR\<30 ml / min / 1.73 m2 (CKD-EPI).
• Individual SGLT2i intolerance
• Child-Pugh class C liver failure
• Mental illness (inability to sign an informed consent, lack of understanding of possible consequences)
• Pregnancy or breastfeeding
• Refusal to sign an informed consent

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (2)

University Clinical Hospital number 1

Moscow, Russia

Location

Сity Сlinical Нospital number 7

Moscow, Russia

Location

Related Publications (1)

• Vaduganathan M, Kumar V, Voors AA, Butler J. Unsolved challenges in diuretic therapy for acute heart failure: a focus on diuretic response. Expert Rev Cardiovasc Ther. 2015 Oct;13(10):1075-8. doi: 10.1586/14779072.2015.1087313. Epub 2015 Sep 10.

  PMID: 26357970 BACKGROUND

Related Links

• The significance level of 0.05 will be used as the limit of the statistical significance of the results, then the sample size of the research should be 100 observation units.

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium Potassium Chloride Symporter Inhibitors; Vasodilator Agents; Digoxin; Vasoconstrictor Agents; dapagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 3, 2021
• Study Start: January 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)