Effects of Ivabradine on Residual Myocardial Ischemia After PCI

NCT ID: NCT03866395

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-05
• Study Completion Date: 2017-03-07

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.

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.

Conditions

Angina Pectoris, Stable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

drug therapy according to the guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ivabradine Group

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

Group Type: EXPERIMENTAL

Ivabradine

Intervention Type: DRUG

Ivabradine 5 mg twice a day

Interventions

Ivabradine

Ivabradine 5 mg twice a day

Intervention Type: DRUG

Other Intervention Names

Procoralan; Corlentor

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Policlinico Umberto I

OTHER

Sponsor Role: lead

Responsible Party

Massimo Mancone

(MD, PhD) Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo Mancone

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular disease, Sapienza, University of Rome, Italy

Locations

Massimo Mancone

Rome, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

04091990

Identifier Type: -

Identifier Source: org_study_id