Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000895583
Ethics application status
Approved
Date submitted
18/05/2014
Date registered
27/08/2015
Date last updated
27/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of implantation of biventricular pacemaker with or without defibrillator on blood vessels function and electrical changes in the hearts of patients with severe heart failure
Scientific title
The effect of implantation of biventricular pacemaker with or without defibrillator on endothelial functions and electrical and mechanical cardiac remodelling in patients with severe heart failure after 6months.
Secondary ID [1] 284623 0
none
Universal Trial Number (UTN)
None
Trial acronym
InCARP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 291931 0
Condition category
Condition code
Cardiovascular 292285 292285 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implantation of biventricular pacemaker with or without automatic implantable defibrillator according to conventional indications. The approximate duration of the implantation procedure is 2 to 3 hours
Intervention code [1] 289405 0
Treatment: Devices
Intervention code [2] 292586 0
Treatment: Surgery
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292151 0
The primary end point of the study will be change in augmentation index response to salbutamol post cardiac resynchronisation therapy.
Salbutamol is administered as part of the primary outcome assessment. Augmentation index is assessed by pulse wave analysis using radial artery application tonometry

This outcome will be compared between responders and non- responders of cardiac resynchronisation therapy
Timepoint [1] 292151 0
6months post implantation of the biventricular pacemaker with or without a defibrillator
Secondary outcome [1] 308308 0
The magnitude of the primary endpoint will be correlated with the extent of improvement of 6 minute walk distance

This outcome will be compared between responders and non- responders of cardiac resynchronisation therapy
Timepoint [1] 308308 0
6months post implantation of the biventricular pacemaker with or without a defibrillator
Secondary outcome [2] 308309 0
Change in redox stress in responders and non responders. This is done by measuring change in thioredoxin interacting protein levels in platelets, measuring levels of asymmetric dimethyl arginine levels in plasma
Timepoint [2] 308309 0
6months post implantation of the biventricular pacemaker with or without a defibrillator
Secondary outcome [3] 316488 0
VO2 max using bicycle ergometer

This outcome will be compared between responders and non- responders of cardiac resynchronisation therapy
Timepoint [3] 316488 0
6months post implantation of the biventricular pacemaker with or without a defibrillator
Secondary outcome [4] 316489 0
left ventricular ejection fraction as well as degree of dyssynchrony using2D and 3D echocardiogram

This outcome will be compared between responders and non- responders of cardiac resynchronisation therapy
Timepoint [4] 316489 0
6months post implantation of the biventricular pacemaker with or without a defibrillator
Secondary outcome [5] 316490 0
change in electrical parameters such as QRS duration, PR intervals, right ventricular refractory periods, biventricular conduction intervals.
These are measured using the implanted device. These are composite secondary outcome.

This outcome will be compared between responders and non- responders of cardiac resynchronisation therapy
Timepoint [5] 316490 0
6 months post implantation of the biventricular pacemaker with or without a defibrillator

Eligibility
Key inclusion criteria
Patients in whom CRT with or without Implantable Cardioverter Defibrillator (ICD) insertion is planned will be eligible for the study irrespective of the bases underlying heart failure
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Inability to attend for follow-up evaluation
b. Treatment with inhibition of platelet ADP receptor activation e.g Clopidogrel
c. Anticipated limitation of exercise capacity due to non cardiac disease eg Severe COPD
d. Severe renal failure, Creatinine >3mg/dl (265.2micromol/L) or on dialysis.
e. Expected life expantancy less than 1 year due to non cardiac causes
f. Inability to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2013
Actual
6/08/2013
Date of last participant enrolment
Anticipated
4/09/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2468 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 2469 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 2470 0
Lyell McEwin Hospital - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 289248 0
Hospital
Name [1] 289248 0
The Queen Elizabeth Hospital Research Foundation
Country [1] 289248 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital Research Foundation
Address
28 Woodville Rd
Woodville South
South Australia 5011
Country
Australia
Secondary sponsor category [1] 287923 0
None
Name [1] 287923 0
None
Address [1] 287923 0
Country [1] 287923 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291018 0
Human Research Ethics Committee (TQEH/LMH/MH) (EC00190)
Ethics committee address [1] 291018 0
Ethics committee country [1] 291018 0
Australia
Date submitted for ethics approval [1] 291018 0
Approval date [1] 291018 0
13/06/2013
Ethics approval number [1] 291018 0
HREC/13/TQEHLMH/25

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

Contacts
Principal investigator
Name 48502 0
Prof John Horowitz
Address 48502 0
University of Adelaide/ The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South
South Australia 5011
Country 48502 0
Australia
Phone 48502 0
+61 8 8222 6000
Fax 48502 0
Email 48502 0
[email protected]
Contact person for public queries
Name 48503 0
John Horowitz
Address 48503 0
University of Adelaide/ The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South
South Australia 5011
Country 48503 0
Australia
Phone 48503 0
+61 8 8222 6000
Fax 48503 0
Email 48503 0
[email protected]
Contact person for scientific queries
Name 48504 0
Chukwudiebube Ajaero
Address 48504 0
University of Adelaide/ The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South
South Australia 5011
Country 48504 0
Australia
Phone 48504 0
+61 8 8222 6000
Fax 48504 0
Email 48504 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.