Effects of Ivabradine on Residual Myocardial Ischemia After PCI

Azienda Policlinico Umberto I

Status and phase

Completed

Phase 4

Conditions

Angina Pectoris, Stable

Treatments

Drug: Ivabradine

Study type

Interventional

Funder types

Other

Identifiers

NCT03866395

04091990

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.