Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000684820
Ethics application status
Approved
Date submitted
22/06/2012
Date registered
26/06/2012
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 Tadalafil
Scientific title
Novel Interventions in Heart Failure with Preserved Ejection Fraction -a single centre, randomised double blind placebo cross-over pilot study using Tadalafil, 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 , Flinders University.
Secondary ID [1] 280725 0
Nil
Universal Trial Number (UTN)
U1111-1132-0591
Trial acronym
NIHEF-2012T
(Novel Interventions in Heart Failure with Preserved Ejection Fraction using Tadalafil) 20- refers to the number of patients in the trial, 2012- refers to the year of study, T refers to first letter in Tadalafil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure with Preserved Ejection Fraction 286771 0
Condition category
Condition code
Cardiovascular 287079 287079 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effect of Tadalafil in Heart failure with preserved ejection fraction
Dose of Tadalafil-40mg once daily, oral capsules
For 8 weeks and then, there is a 2 week wash out period and they will be crossed over to placebo for 8 weeks
Intervention code [1] 285148 0
Treatment: Drugs
Comparator / control treatment
Placebo-microcellulose oral capsule
Control group
Placebo

Outcomes
Primary outcome [1] 287402 0
Improvement in 6 minute walk test
Timepoint [1] 287402 0
Baseline, 8 and 18 weeks after randomistaion
Primary outcome [2] 287403 0
Peak oxygen consumption based on Cardiopulmonary exercise testing. The VO2 is calculated from the heart rate difference between rest and peak exercise.
During the cardiopulmonary exercise test, Heart rate, Blood pressure and the inspired oxygen levels are continously measured by ECG and other monitors.
Timepoint [2] 287403 0
Baseline, 8 and 18 weeks after randomistaion
Primary outcome [3] 287404 0
New York Heart Association Class, as assessed by interview
Timepoint [3] 287404 0
Baseline, 8 and 18 weeks after randomistaion
Secondary outcome [1] 298070 0
RV volume as assessed on cardiac magnetic resonance imaging
Timepoint [1] 298070 0
Baseline, 8 and 18 weeks after randomistaion
Secondary outcome [2] 298071 0
RVEF as assessed on cardiac magnetic resonance imaging
Timepoint [2] 298071 0
Baseline, 8 and 18 weeks after randomistaion
Secondary outcome [3] 298072 0
LV diastolic parameters (E/A, E/E') as assessed on Echocardiogram
Timepoint [3] 298072 0
Baseline, 8 and 18 weeks after randomistaion
Secondary outcome [4] 298073 0
Pulmonary artery pressure as assessed on Echocardiogram
Timepoint [4] 298073 0
Baseline, 8 and 18 weeks after randomistaion
Secondary outcome [5] 298074 0
Cardiac output as assessed on cardiac magnetic resonance imaging
Timepoint [5] 298074 0
Baseline, 8 and 18 weeks after randomistaion
Secondary outcome [6] 298075 0
BNP levels on blood test sample
Timepoint [6] 298075 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 15, deceleration time less than or equal to 140ms
Systolic pulmonary artery pressure over 30 mm of Hg
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
Contraindications to Tadalafil ; Nitrate use in any form
Contraindications to MRI
Significant valvular or coronary disease as primary cause of HF
Hypertrophic cardiomyopathy, cardiac amyloidosis, sarcoidosis
GFR greater than or equal to 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 Tadalafil or placebo once 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 done by numbered containers by the company that does the randomisation for us.
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] 285507 0
Self funded/Unfunded
Name [1] 285507 0
Country [1] 285507 0
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Reseasrch Institute
Address
Box 15,Level 1b,
Mark Oliphant Building
Laffer Drive,Science Park
Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 284347 0
None
Name [1] 284347 0
Address [1] 284347 0
Country [1] 284347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287522 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 287522 0
Ethics committee country [1] 287522 0
Australia
Date submitted for ethics approval [1] 287522 0
Approval date [1] 287522 0
13/06/2012
Ethics approval number [1] 287522 0
207.12b

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

Contacts
Principal investigator
Name 34356 0
Address 34356 0
Country 34356 0
Phone 34356 0
Fax 34356 0
Email 34356 0
Contact person for public queries
Name 17603 0
Dr. Govindarajan Srinivasan
Address 17603 0
Department of Cardiovascular Medicine
Flinders Medical Centre,1 Flinders Drive
Bedford Park, SA, 5042
Country 17603 0
Australia
Phone 17603 0
+61-08-8201 7700
Fax 17603 0
+61-08-82017701
Email 17603 0
[email protected]
Contact person for scientific queries
Name 8531 0
Dr. Govindarajan Srinivasan
Address 8531 0
Department of Cardiovascular Medicine
Flinders Medical Centre,1 Flinders Drive
Bedford Park, SA, 5042
Country 8531 0
Australia
Phone 8531 0
+61-08-8201 7700
Fax 8531 0
+61-08-82017701
Email 8531 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.