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Effects of Ivabradine on Residual Myocardial Ischemia After PCI

Primary Purpose

Angina Pectoris, Stable

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ivabradine
Sponsored by
Azienda Policlinico Umberto I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris, Stable focused on measuring Stable angina, coronary artery diseases, heart rate, exercise tolerability, diastolic function, ivabradine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massimo Mancone

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Ivabradine Group

Arm Description

drug therapy according to the guidelines

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

Outcomes

Primary Outcome Measures

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.
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.
chronotropic reserve (unit of measure: beats per minute)
difference between resting heart rate and maximum heart rate at peak exercise
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.

Secondary Outcome Measures

diastolic function: PW Doppler E wave (unit of measure: cm/sec)
ventricular filling echocardiographic parameter
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.
diastolic function: PW Doppler A wave (unit of measure: cm/sec)
ventricular filling echocardiographic parameter
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)

Full Information

First Posted
June 1, 2018
Last Updated
March 5, 2019
Sponsor
Azienda Policlinico Umberto I
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1. Study Identification

Unique Protocol Identification Number
NCT03866395
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 5, 2015 (Actual)
Primary Completion Date
March 7, 2017 (Actual)
Study Completion Date
March 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Policlinico Umberto I

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Stable
Keywords
Stable angina, coronary artery diseases, heart rate, exercise tolerability, diastolic function, ivabradine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
drug therapy according to the guidelines
Arm Title
Ivabradine Group
Arm Type
Experimental
Arm Description
drug therapy according to the guidelines + Ivabradine 5 mg twice a day
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Other Intervention Name(s)
Procoralan, Corlentor
Intervention Description
Ivabradine 5 mg twice a day
Primary Outcome Measure Information:
Title
Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg)
Description
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.
Time Frame
30 days
Title
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)
Description
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.
Time Frame
30 days
Title
chronotropic reserve (unit of measure: beats per minute)
Description
difference between resting heart rate and maximum heart rate at peak exercise
Time Frame
30 days
Title
muscular work (unit of measure: watt)
Description
These, indirectly, reflect the myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
diastolic function: PW Doppler E wave (unit of measure: cm/sec)
Description
ventricular filling echocardiographic parameter
Time Frame
30 days
Title
diastolic function: TDI derived E' measurements (unit of measure: cm/sec)
Description
ventricular filling echocardiographic parameter. Mitral annular E' velocity was estimated as the average between lateral and septal velocity.
Time Frame
30 days
Title
diastolic function: PW Doppler A wave (unit of measure: cm/sec)
Description
ventricular filling echocardiographic parameter
Time Frame
30 days
Title
E/E' ratio
Description
ventricular filling echocardiographic parameter. TDI derived E' measurements (unit of measure: cm/sec). PW Doppler E wave (unit of measure: cm/sec)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Mancone
Organizational Affiliation
Department of Cardiovascular disease, Sapienza, University of Rome, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massimo Mancone
City
Rome
ZIP/Postal Code
00100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Ivabradine on Residual Myocardial Ischemia After PCI

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