Clinical trial NCT03866395: Effects of Ivabradine on Residual Myocardial Ischemia After PCI
Official title: Effects of Ivabradine on Residual Myocardial Ischemia After PCI Evaluated by Stress Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Angina Pectoris, Stable
Keywords: Stable angina
coronary artery diseases
heart rate
exercise tolerability
diastolic function
ivabradine
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg)
timeFrame: 30 days
measure: 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)
timeFrame: 30 days
measure: chronotropic reserve (unit of measure: beats per minute)
timeFrame: 30 days
measure: muscular work (unit of measure: watt)
timeFrame: 30 days
Secondary outcomes:
measure: diastolic function: PW Doppler E wave (unit of measure: cm/sec)
timeFrame: 30 days
measure: diastolic function: TDI derived E' measurements (unit of measure: cm/sec)
timeFrame: 30 days
measure: diastolic function: PW Doppler A wave (unit of measure: cm/sec)
timeFrame: 30 days
measure: E/E' ratio
timeFrame: 30 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Massimo Mancone
Study officials:
affiliation: Department of Cardiovascular disease, Sapienza, University of Rome, Italy
name: Massimo Mancone
role: PRINCIPAL_INVESTIGATOR
References: