Efficacy of dapagliflozin in the treatment of HFrEF with moderate to severe obstructive sleep apnea syndrome: a prospective, randomized controlled clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100049834

Enrollment

Unknown

Registered

2021-08-10

Start date

2021-09-01

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with obstructive sleep apnea syndrome

Interventions

Treatment group:dapagliflozin

Control group:Standard optimized treatment of heart failure

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate, understand and sign the informed consent; 2. Symptomatic chronic heart failure, NYHA class II-IV, the diagnosis of chronic heart failure should refer to the 2016 ESC Heart Failure Guidelines and the 2018 Chinese Heart Failure Guidelines; the condition is relatively stable, and no intravenous drug treatment is required; 3.LVEF=45ml/min/1.73m2; 7. OSAHS was diagnosed according to the "2016 Edition of the Diagnostic Guidelines for Obstructive Sleep Apnea in Adults"; AHI>=15 times/h.

Exclusion criteria

Exclusion criteria: 1. Has participated in other clinical investigators; 2. Hemodynamic instability; 3. Allergic to the drug or its components; 4. Acute myocardial infarction; 5. Active liver disease or severe liver insufficiency; 6. Known active infection or severe blood disease or endocrine dysfunction; 7. History of COPD and asthma or other serious lung diseases; 8. History of stroke, peripheral or central nerve abnormalities, cerebrovascular disease; 9. Pregnant and lactating women; 10. Glycated hemoglobin (HbA1c) >= 7.0%; 11. Previous use of dapagliflozin.

Design outcomes

Primary

Measure	Time frame
Respiratory Disorder Index;	—

Secondary

Measure	Time frame
Respiratory Disorder Index decreased by 20% in the proportion of patients;Respiratory Disorder Index decreased by 50% in the proportion of patients;Epworth Somnolence Scale;ejection fraction;left ventricular end-diastolic diameter;Serum B-type natriuretic peptide level;renal function;liver function;electrolyte;blood routine;The Minnesota living with heart failure questionnaire;European Five-dimensional Health Scale;inflammatory cytokine;Lowest oxygen saturation at night;	—

Measure

Time frame

Respiratory Disorder Index decreased by 20% in the proportion of patients;Respiratory Disorder Index decreased by 50% in the proportion of patients;Epworth Somnolence Scale;ejection fraction;left ventricular end-diastolic diameter;Serum B-type natriuretic peptide level;renal function;liver function;electrolyte;blood routine;The Minnesota living with heart failure questionnaire;European Five-dimensional Health Scale;inflammatory cytokine;Lowest oxygen saturation at night;

—

Countries

China

Contacts

Public ContactTong Jiayi

Zhongda Hospital, Affliated to Southeast University

101007925@seu.edu.cn+86 13701464321

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026