Control of Sinus Node Tachycardia as an Additional Therapy in Patients With Decompensated Heart Failure

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo

Criteria

Inclusion Criteria:

• Sinus node rhythm

• HR> 80 bpm

• Hospitalization for DHF

• Ejection fraction ≤ 40%

• Sign informed consent

Exclusion Criteria:

• 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