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Safety and efficacy of levosimendan combined with dopamine in patients with heart failure complicated with hypotension (SBP < 100mmHg)

Safety and efficacy of levosimendan combined with dopamine in patients with heart failure complicated with hypotension (SBP < 100mmHg)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039714
Enrollment
Unknown
Registered
2020-11-06
Start date
2021-04-10
Completion date
Unknown
Last updated
2021-02-16

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

Conditions

Heart failure

Interventions

Control group:standard heart failure therapy
Experimental group:standard heart failure therapy combined with levosimendan and dopamine

Sponsors

The First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old with definite diagnosis of congestive heart failure, regardless of gender, sign informed consent; 2. In patients with NYHA grade III - IV, EF <= 40%; 3. Patients with systolic blood pressure <= 100mmhg; 4. Patients who received routine treatment (such as diuretics, ACEI, ARB, Arni, digitalis, etc.) but had poor effect.

Exclusion criteria

Exclusion criteria: 1. Patients with severe electrolyte disorder; 2. Patients with severe liver or renal insufficiency, EGFR < 30 ml / min / 1.73 M2 (MDRD formula), or severe hematological diseases; 3. Patients with malignant arrhythmia events in recent 3 months; 4. Pregnant or lactating women; 5. The subjects who are allergic to levosimendan or have used levosimendan within 30 days; 6. Those who have participated in other clinical trials within 30 days or whose data are incomplete or who are unwilling to participate in this project.

Design outcomes

Primary

MeasureTime frame
incidence of MACE;improvement of cardiac function;

Secondary

MeasureTime frame
average hospitalization days;average hospitalization cost;cognitive function;

Countries

China

Contacts

Public ContactYuedong Ma

The First Affiliated Hospital of Sun Yat-Sen University

maydong@mail.sysu.edu.cn+86 13480209157

Outcome results

None listed

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