Effects of Ivabradine on Residual Myocardial Ischemia After PCI

Angina Pectoris, Stable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03866395
• Other study ID #: 04091990
• Status: Completed
• Phase: Phase 4
• Start date: March 5, 2015
• Est. completion date: March 7, 2017

Study information

• Verified date: March 2019
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 7, 2017
• Est. primary completion date: March 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Stable
• Angina, Stable
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Drug:
• Ivabradine
Ivabradine 5 mg twice a day

Locations

Country	Name	City	State
Italy	Massimo Mancone	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg)	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.	30 days
Primary	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)	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.	30 days
Primary	chronotropic reserve (unit of measure: beats per minute)	difference between resting heart rate and maximum heart rate at peak exercise	30 days
Primary	muscular work (unit of measure: watt)	These, indirectly, reflect the myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.	30 days
Secondary	diastolic function: PW Doppler E wave (unit of measure: cm/sec)	ventricular filling echocardiographic parameter	30 days
Secondary	diastolic function: TDI derived E' measurements (unit of measure: cm/sec)	ventricular filling echocardiographic parameter. Mitral annular E' velocity was estimated as the average between lateral and septal velocity.	30 days
Secondary	diastolic function: PW Doppler A wave (unit of measure: cm/sec)	ventricular filling echocardiographic parameter	30 days
Secondary	E/E' ratio	ventricular filling echocardiographic parameter. TDI derived E' measurements (unit of measure: cm/sec). PW Doppler E wave (unit of measure: cm/sec)	30 days