ACTRN12612000684820Not yet recruitingPhase 4
ovel 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.
South Australian Health and Medical Reseasrch Institute0 sites20 target enrollmentStarted: June 26, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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
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
Investigators
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