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Clinical Trials/ACTRN12612000684820
ACTRN12612000684820
Not yet recruiting
Phase 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 enrollmentJune 26, 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Heart Failure with Preserved Ejection Fraction
Sponsor
South Australian Health and Medical Reseasrch Institute
Enrollment
20
Status
Not yet recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 26, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
South Australian Health and Medical Reseasrch Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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