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Impact of Dapagliflozin on the sympathetic activity in chronic heart failure with reduced ejection fraction: Rationale and design of the randomized, double-blind, palcebo controlled trial

Impact of Dapagliflozin on the sympathetic activity in chronic heart failure with reduced ejection fraction: Rationale and design of the randomized, double-blind, palcebo controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052426
Enrollment
Unknown
Registered
2021-10-26
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

chronic heart failure

Interventions

dapagliflozin group:Dagliazin was taken orally 10mg/ day
placebo group:Oral placebo was taken orally 10mg/ day

Sponsors

The First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years old; 2. Patients should undergo echocardiography before the test. Left ventricular ejection fraction (LVEF); 40%, New York Heart Association (NYHA) class II, patients receiving standard heart failure medication; 3. Plasma NT-proBNP greater than 600 pg/mL. Plasma NT-proBNP greater than 900 pg/mL in heart failure complicated with atrial fibrillation or atrial flutter; 4. Cardiac assist devices can still be incorporated (including ICD, CRT-D, or both).

Exclusion criteria

Exclusion criteria: 1. Patients who have taken dapagliflozin before being included in the study; 2. Those who have serious adverse reactions to SGLT2 inhibitors; 3. Hypotension or blood pressure less than 105/70 mmHg; 4. Acute renal insufficiency or chronic kidney disease 5) Liver dysfunction; 6. Pregnant or lactating women; 7. Malignant tumors (under active treatment) or other life-threatening diseases; 8. Severe mental illness; 9. The doctor believes that the patient is not suitable for taking dapagliflozin.

Design outcomes

Primary

MeasureTime frame
Heart Rate Variability;ventricular arrhythmias;

Secondary

MeasureTime frame
Plasma renin activity;Angiotensin I;lasma aldosterone;Angiotensin II;left ventricular end-diastolic diameter;left ventricular end-systolic diameter;ejection fraction;left ventricular mass index;

Countries

China

Contacts

Public ContactTang Baopeng

The First Affiliated Hospital of Xinjiang Medical University

tangbaopeng111@163.com+86 13579881111

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026