What is the clinical evidence from this study?

Study design: Observational. Population: Hypertrophic cardiomyopathy (HCM) (n=16). Intervention: Cibenzoline vs. Baseline (before administration). Primary outcome: Left ventricular end-diastolic pressure (LVEDP) in HOCM patients (p=0.0106).

January 1, 2007Open Access

Effect of Intravenous Administration of Cibenzoline on Left Ventricular Diastolic Pressures in Patients With Hypertrophic Cardiomyopathy Its Relationship to Transmitral Doppler Flow Profiles

Key Result

Intravenous administration of cibenzoline significantly reduced left ventricular end-diastolic pressure from 22 to 14 mmHg in patients with hypertrophic obstructive cardiomyopathy.

Study Design

Type

Observational (n=16)

Multicenter

Structured PICO

Does intravenous cibenzoline improve left ventricular diastolic pressures and transmitral Doppler flow profiles in patients with hypertrophic cardiomyopathy?

Population

16 patients with hypertrophic cardiomyopathy (HCM), including 7 with hypertrophic obstructive cardiomyopathy (HOCM) and 9 with hypertrophic nonobstructive cardiomyopathy (HNCM), based in Japan.

Intervention

Intravenous administration of 1.4 mg/kg of cibenzoline into the cubital vein over 5 minutes.

Outcome

Changes in aortic and left ventricular (LV) pressures (minimal and end-diastolic), LV pressure gradient (LVPG), and transmitral Doppler velocity profiles (E-wave, A-wave, E/A ratio) at 5 minutes post-administration.surrogate

Intravenous cibenzoline acutely reduces left ventricular diastolic pressures and improves transmitral Doppler flow profiles in patients with both obstructive and nonobstructive hypertrophic cardiomyopathy.

Main Result

Absolute Event Rate: 14% vs 22%

p-value: p=0.0106

Limitations

The exact mechanism of cibenzoline for improving LV function remains to be determined
Lack of estimation of peak positive and negative LV dp/dt and the time constant of the LV pressure
Lack of Doppler interrogation of pulmonary venous flow and analysis of Doppler tissue velocities of annular motion

Abstract

BACKGROUND: Cibenzoline is able to improve left ventricular (LV) diastolic dysfunction in patients with hypertrophic cardiomyopathy (HCM), but the exact mechanism remains to be determined. METHODS AND RESULTS: The present study was designed to elucidate the effect of intravenous administration of 1.4 mg/kg of cibenzoline on aortic and LV pressures, and transmitral Doppler flow pattern in 7 patients with hypertrophic obstructive cardiomyopathy (HOCM) and 9 patients with hypertrophic nonobstructive cardiomyopathy (HNCM). Before and at the end of the administration, aortic and LV pressures, LV pressure gradient (LVPG) and transmitral Doppler velocity profiles were examined. After the administration of cibenzoline, LV minimal and end-diastolic pressures decreased from 9+/-4 mmHg to 1+/-5 mmHg (p=0.0049) and from 22+/-7 mmHg to 14+/-5 mmHg (p=0.0106) in patients with HOCM, and from 9+/-5 mmHg to 5+/-3 mmHg (p=0.0036) and from 20+/-6 mmHg to 14+/-3 mmHg (p=0.0033) in patients with HNCM. LVPG decreased in all patients with HOCM. E-wave velocity increased, A-wave velocity decreased, and thus the E/A ratio increased from 0.77+/-0.29 to 1.20+/-0.48 (p=0.0004). CONCLUSIONS: Reduction of LV diastolic pressures by intravenous administration of cibenzoline may be related to an improvement in the E/A ratio in patients with HCM.

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