Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000710820
Ethics application status
Approved
Date submitted
22/06/2012
Date registered
3/07/2012
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel Interventions in Heart Failure with Preserved Ejection Fraction using ivabradine
Scientific title
Novel Interventions in Heart Failure with Preserved Ejection Fraction -a single centre, randomised double blinded placebo cross-over pilot study using IVABRADINE, to assess the effect on 6 minute walk test, peak oxygen consumption and New York heart association Class of symptoms, from the Flinders Clinical Research group, Flinders University.
Secondary ID [1] 280723 0
Nil
Universal Trial Number (UTN)
U1111-1132-0432
Trial acronym
NIHEF-2012i(Novel Interventions in Heart Failure with Preserved Ejection Fraction using ivabradine)
20 refres to the number of patients, 2012 refres the year of study, i- refers to first letter in ivabradine
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure with Preserved Ejection Fraction 286769 0
Condition category
Condition code
Cardiovascular 287077 287077 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effect of Ivabradine in Heart failure with preserved ejection fraction
Ivabradine 5-7.5 mg oral tablets twice daily depending on heart rate at the time of randomisation for 8 weeks followed by a 2 week wash out period and cross over to microcelullose placebo for 8 weeks.
Intervention code [1] 285146 0
Treatment: Drugs
Comparator / control treatment
Placebo- microcellulose oral capsule twice daily
Control group
Placebo

Outcomes
Primary outcome [1] 287400 0
Improvement in 6 minute walk test
Timepoint [1] 287400 0
Baseline, 8 and 18 weeks after randomistaion
Primary outcome [2] 287409 0
Peak VO2 as assessed by cardio-pulmonary exercise testing. The Vo2 is calculated using the difference between the heart rate at rest and at peak exercise. The heart rate blood pressure and concentaration of inspired oxygen will be monitored regularlr by monitors.
Timepoint [2] 287409 0
Baseline, 8 and 18 weeks after randomistaion
Secondary outcome [1] 298067 0
RV volume as assessed on cardiac magnetic resonance imaging
Timepoint [1] 298067 0
Baseline, 8 and 18 weeks after randomistaion
Secondary outcome [2] 298088 0
Diastolic parametres of E/E', E/A ratio on echocardiogram
Timepoint [2] 298088 0
Baseline, 8 and 18 weeks after randomistaion

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years
HF-PEF (LVEF greater than or equal to 50% within 6m of randomisation)
NYHA II-III
Diastolic dysfunction on echo
E/A equal to 1, E/E’ equal to or greater than 15, deceleration time less than or equal to 140ms
Heart rate over 70/min
Stable disease, confirmed by no hospital admissions or HF medication changes within 3m prior to randomisation
Informed consent
No other causes for exertional dyspnoea
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Atrial Fibrillation
Contraindications to MRI
Significant valvular or coronary disease as primary cause of HF
Hypertrophic cardiomyopathy, cardiac amyloidosis, sarcoidosis
GFR equal to or greater than 45 ml/min

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
20 patients recruited for the study will be randomised to receive Ivabradine or placebo twice daily for 8 weeks in addition to their usual medications. They will then be crossed over to the other treatment for 8 weeks after a 2 week wash-out period.
Allocation is by numberedcontainers, which is done by the randomisation company.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to study drug or placebo is based on a block randomisation. Blocking is used to ensure that comparison groups will be generated according to a predetermined ratio, usually 1:1 or groups of approximately the same size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285505 0
Self funded/Unfunded
Name [1] 285505 0
Country [1] 285505 0
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute
Address
Box 15, lEVEL 1B
Mark Oliphant Building
Laffer Drive, Science Park
Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 284345 0
None
Name [1] 284345 0
Address [1] 284345 0
Country [1] 284345 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287520 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 287520 0
Ethics committee country [1] 287520 0
Australia
Date submitted for ethics approval [1] 287520 0
Approval date [1] 287520 0
13/06/2012
Ethics approval number [1] 287520 0
207.12a

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34354 0
Address 34354 0
Country 34354 0
Phone 34354 0
Fax 34354 0
Email 34354 0
Contact person for public queries
Name 17601 0
Dr. Govindarajan Srinivasan
Address 17601 0
Department of Cardiovascular Medicine
Flinders Medical Centre, 1,Flinders Drive
Bedford Park, SA, 5042
Country 17601 0
Australia
Phone 17601 0
+61-08-82017916
Fax 17601 0
+61-08-82017701
Email 17601 0
[email protected]
Contact person for scientific queries
Name 8529 0
Dr. Govindarajan Srinivasan
Address 8529 0
Department of Cardiovascular Medicine
Flinders Medical Centre, 1, Flinders Drive
Bedford Park, SA, 5042
Country 8529 0
Australia
Phone 8529 0
+61-08-82017916
Fax 8529 0
+61-08-82017701
Email 8529 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.