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Register:	ISRCTN
Last refreshed on:	4 May 2020
Main ID:	ISRCTN90566768
Date of registration:	18/10/2011
Prospective Registration:	No
Primary sponsor:	Institut de Recherches Internationales Servier (France)
Public title:	Effects of ivabradine in patients with coronary artery disease and suffering from a reversible contractility dysfunction of the heart muscle
Scientific title:	Effects of oral administration of ivabradine (7.5 mg bid) on post-ischaemic stunning induced by exercise stress in patients with coronary artery disease and exercise inducible ischaemia
Date of first enrolment:	01/09/2011
Target sample size:	15
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN90566768
Study type:	Interventional
Study design:	Exploratory open label study (Treatment)
Phase:	Not Applicable

Countries of recruitment
Italy

Contacts

Name:	Paolo G. Camici
Address:	San Raffaele University Insititute of Science Via Olgettina 60 20132 Milan Italy
Telephone:
Email:
Affiliation:

Name:
Address:
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Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 30 to 75 years
2. Male or female
3. Evidence of coronary artery disease proven by clinical history
4. Sinus rhythm and resting heart rate equal or higher than 70 bpm
5. Exercise-inducible myocardial ischaemia
6. Myocardial stunning, assessed by cardiac echocardiography

Exclusion criteria:
1. Angina at rest or angina class IV
2. Unstable cardiovascular condition
3. Previous treament with anti-anginal medication within 1 week before inclusion
4. Significant abnormalities in the laboratory blood evaluation
5. Contra-indication to the administration of ivabradine

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary artery disease
Circulatory System
Coronary artery disease

Intervention(s)

1. Two film-coated tablets of 7.5 mg or 5 mg of ivabradine
2. Control: placebo bid

Primary Outcome(s)

1. Myocardial stunning, by evaluating changes in regional wall motion measuring 2D Strain/Strain rate
2. Measured at selection visit, inclusion visit and end of treatment visit

Secondary Outcome(s)

1. Arterial elastance, measured at selection visit, inclusion visit and end of treatment visit
2. Ventricular arterial coupling, measured at selection visit, inclusion visit and end of treatment visit
3. Safety, measured at each visit

Secondary ID(s)

CL2-16257-095

2011-000783-98

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics approval was obtained before recruitment of the first participants

Results

Results available:	Yes
Date Posted:
Date Completed:	30/09/2012
URL:

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