Status:
UNKNOWN
Control of Sinus Node Tachycardia as an Additional Therapy in Patients With Decompensated Heart Failure
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Decompensated Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate control in patients with decompensated heart failure (DHF).
Detailed Description
Sympathetic hyperactivity and consequent increase in heart rate (HR) are physiological responses to low cardiac output in patients with decompensated heart failure (DHF). However, elevated HR may beco...
Eligibility Criteria
Inclusion
- Sinus node rhythm
- HR\> 80 bpm
- Hospitalization for DHF
- Ejection fraction ≤ 40%
- Sign informed consent
Exclusion
- Systolic blood pressure \<85 mmHg
- Signs of hypoperfusion
- Dobutamine\>15 mcg/Kg/min
- Acute myocarditis
- Primary valvular disease requiring surgery
- Stroke in the last three months
- Hypertrophic or restrictive cardiomyopathy
- Sinus node disease
- Atrial fibrillation or flutter
- Second or third degree atrio-ventricular blockade
- Long QT syndrome
- Severe pulmonary disease
- Pulmonary embolism in the last three months
- Need for invasive ventilatory support
- Septicemia or septic shock
- Hepatic failure
- Creatinine \> 2.5 mg/dL
- Hemodialysis
- Advanced malignancy
- Pregnancy or lactation
- Immunosuppressive therapy
- Use of cytochrome P450 inhibitors
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02236247
Start Date
May 1 2013
End Date
August 1 2017
Last Update
January 2 2017
Active Locations (1)
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1
Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School
São Paulo, São Paulo, Brazil, 05403-900