Efficacy of Ibabradine and Beta-blocker Therapy in Patients with Heart Failure with Reduced Ejection Fraction

JRCT ID: jRCTs041200027

Registered date:08/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 02/11/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): We will randomize the patients with heart failure with reduced left ventricular ejection fraction into the ibabradine arm and the control arm and follow them for six months.

Outcome(s)

• Primary Outcome: A daily dose of beta-blocker equivalent to the carvedilol at six months

Secondary Outcome

Six-month left ventricular end-diastolic diameter and ejection fraction
Six-month plasma B-type natriuretic peptide level
Six-month six-minute walk distance
Six-month readmission due to heart failure

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Heart failure with reduced left ventricular ejection fraction due to ischemic or non-ischemic cardiomyopathy
2. Refractory to the up-titration of beta-blocker due to failing symptom
3. Sinus rhythm, heart rhythm above 75 bpm, and systolic blood pressure above 90 mmHg
4. New York Heart Association functional class III or IV

Exclude criteria

1. Those with a plan of surgical interventions during the observational period
2. Allergy to the beta-blocker
3. Heart rate below 75 bpm or systolic blood pressure below 90 mmHg
4. Chronic obstructive pulmonary disease or bronchial asthma is not a contraindication

Related Information

• Primary Sponsor: Kinugawa Koichiro
• Source(s) of Monetary Support: ONO Pharmaceutical CO., LTD.