Effect of Ivabradine on left ventricular diastolic function

JRCT ID: jRCTs051200059

Registered date:24/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: left ventricular diastolic function in patients with heart failure
• Date of first enrollment: 06/11/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): IVAbradine on left ventricular diastolic function in patients with heart failure with Preserved Ejection Fraction

Outcome(s)

• Primary Outcome: A change in left ventricular diastolic function (E/e') between baseline and 12 weeks after the start of administration of ivabradine.

Secondary Outcome

1.A change in brain natriuretic peptide (BNP) between baseline and 12 weeks after the start of administration of ivabradine.
2.A change in left atrial volume index between baseline and 12 weeks after the start of administration of ivabradine.
3.A change in global longitudinal strain (GLS) between baseline and 12 weeks after the start of administration of ivabradine.
4.A chang e in dyspnea on exertion between baseline and 12 weeks after the start of administrati on of ivabradine.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Age 20 years or older.
2.Patients with HFpEF(Left ventricular ejection fraction(LVEF)over 50%) including Stage A heart failure(HF).
Patients with or without receiving cardio-protective drugs such as angiotensin-converting enzyme(ACE)inhibitors, angiotensin receptor blocker(ARB)s, or beta-blockers, and mineralocorticoid receptor antagonist(MRA)s.
3.Patients with resting heart rate 75beats/min or more and available for additional administration of ivabradine.
4.Patients with sinus rhythm.
5.Patients with New York Heart Association functional classification and receiving cardio-protective drugs such as ACE inhibitors, ARBs, beta-blockers, or MRA have been stable for 4 weeks before enrollment.
6.Written consent from the individual regarding research participation.

Exclude criteria

1.Patients with atrial fibrillation.
2.Patients with unstable or acute HF.
3.Patients with severe hypotension (systolic blood pressure <90mmHg or diastolic blood pressure <50mmHg)
4.Patients with sick sinus syndrome, sinoatrial block, or third-degree atrioventricular block.
5.Patients with sick sinus syndrome, sinoatrial block, or third-degree atrioventricular block.
6.Patients with severe liver disease
7.Patients with receiving ritonavir, josamycin, itraconazole, clarithromycin, cobicistat, indinavir, voriconazole, nelfinavir, saquinavir, telaprevir, verapamil, or diltiazem.
8.Pregnant, suspected of being pregnant, or lactating women, female patient wishing to become pregnant.
9.Patients with hypersensitivity to ivabradine.
10.Patients during use of ivabradine or with history of usage of ivabradine.
11.Judged as an inappropriate patient by the investigator or sub-investigator at the hospital (site) for any other reasons.

Related Information

• Primary Sponsor: Tanaka Hidekazu