Effects of Ivabradine on Residual Myocardial Ischemia After PCI

Sponsor

Azienda Policlinico Umberto I (Other)

Overall Status

Completed

CT.gov ID

NCT03866395

Collaborator

(none)

Enrollment

Location

Arms

24.1

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized pharmacological study evaluating the effects of ivabradine in patients with residual angina after PCI. The role of ivabradine in patients with angina, without systolic dysfunction, is not yet clear. The investigators performed in all patients an echostress to evaluate the effects of therapy with ivabradine after 30 days in terms of exercise tolerance and diastolic function.

Condition or Disease	Intervention/Treatment	Phase
Angina Pectoris, Stable	Drug: Ivabradine	Phase 4

Detailed Description

BACKGROUND. Residual angina after PCI is a frequently-occurring disease. Ivabradine improves symptoms but its role in patients without left-ventricular systolic dysfunction is still unclear. The aim was to quantify the effects of ivabradine in terms of MVO2 indicators and diastolic function.

METHODS. 28 consecutive patients with residual angina after PCI were randomized to ivabradine 5 mg twice/day(IG) or standard therapy(CG). All patients performed a stress echocardiography at the enrollment and after 30 days. Myocardial oxygen consumption was estimated from: double product(DP); triple product(TP) integrating DP with ejection-time(ET). Diastolic function was evaluated determining E and A waves, E' measurements and E/E' ratio both at rest and at the peak of exercise.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Ivabradine on Residual Myocardial Ischemia After PCI Evaluated by Stress Echocardiography

Actual Study Start Date :

Mar 5, 2015

Actual Primary Completion Date :

Mar 7, 2017

Actual Study Completion Date :

Mar 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group drug therapy according to the guidelines
Experimental: Ivabradine Group drug therapy according to the guidelines + Ivabradine 5 mg twice a day	Drug: Ivabradine Ivabradine 5 mg twice a day Other Names: Procoralan Corlentor

Arm

Intervention/Treatment

No Intervention: Control Group

drug therapy according to the guidelines

Experimental: Ivabradine Group

drug therapy according to the guidelines + Ivabradine 5 mg twice a day

Drug: Ivabradine

Ivabradine 5 mg twice a day

Other Names:

Procoralan

Corlentor

Outcome Measures

Primary Outcome Measures

Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg) [30 days]
These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
Triple product (TP), calculated as a product between HR, systolic blood pressure and ejection time. (unit of measure: beats per minute x mmHg x msec) [30 days]
These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
chronotropic reserve (unit of measure: beats per minute) [30 days]
difference between resting heart rate and maximum heart rate at peak exercise
muscular work (unit of measure: watt) [30 days]
These, indirectly, reflect the myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.

Secondary Outcome Measures

diastolic function: PW Doppler E wave (unit of measure: cm/sec) [30 days]
ventricular filling echocardiographic parameter
diastolic function: TDI derived E' measurements (unit of measure: cm/sec) [30 days]
ventricular filling echocardiographic parameter. Mitral annular E' velocity was estimated as the average between lateral and septal velocity.
diastolic function: PW Doppler A wave (unit of measure: cm/sec) [30 days]
ventricular filling echocardiographic parameter
E/E' ratio [30 days]
ventricular filling echocardiographic parameter. TDI derived E' measurements (unit of measure: cm/sec). PW Doppler E wave (unit of measure: cm/sec)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

coronary artery disease with chronic stable angina for more than three months (Canadian Cardiovascular Society-CCS-class I-III);
percutaneous revascularization with stent implantation at least one;
signs/symptoms of residual ischemia; sinus rhythm; HR ≥ 70 bpm at rest;
ability to perform an echocardiogram stress test with the tilting bicycle stress test (BST);
good acoustic window;
age ≥ 18 years.

Exclusion Criteria:

drugs intolerance or hypersensitivity
EF ≤ 40 %
NYHA class III to IV;
CCS IV
atrial fibrillation or flutter
presence of a pacemaker or implantable defibrillator
II or III degree AV block
HR ≤ 70 bpm at rest or sick sinus syndrome
any condition that could interfere with the ability to exercise stress test like Wolff- Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy;
rate-corrected QT interval (QTc) greater than 500 ms or the use of drugs that prolong the QTc interval
symptomatic hypotension or uncontrolled hypertension (systolic blood pressure at rest ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)
severe liver disease and severe renal impairment (creatinine clearance ≤ 30 ml/min)
electrolyte disorders
uncontrolled thyroid disease
pregnancy.