ovel Interventions in Heart Failure with Preserved Ejection Fraction using Tadalafil

Phase 4

• Conditions: Cardiovascular - Other cardiovascular diseases; Heart Failure with Preserved Ejection Fraction

• Registration Number: ACTRN12612000684820
• Lead Sponsor: South Australian Health and Medical Reseasrch Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in 6 minute walk test[Baseline, 8 and 18 weeks after randomistaion];Peak oxygen consumption based on Cardiopulmonary exercise testing. The VO2 is calculated from the heart rate difference between rest and peak exercise.<br>During the cardiopulmonary exercise test, Heart rate, Blood pressure and the inspired oxygen levels are continously measured by ECG and other monitors.[Baseline, 8 and 18 weeks after randomistaion];New York Heart Association Class, as assessed by interview[Baseline, 8 and 18 weeks after randomistaion]

Secondary Outcome Measures

Name	Time	Method
RV volume as assessed on cardiac magnetic resonance imaging[Baseline, 8 and 18 weeks after randomistaion];RVEF as assessed on cardiac magnetic resonance imaging[Baseline, 8 and 18 weeks after randomistaion];LV diastolic parameters (E/A, E/E') as assessed on Echocardiogram[Baseline, 8 and 18 weeks after randomistaion];Pulmonary artery pressure as assessed on Echocardiogram[Baseline, 8 and 18 weeks after randomistaion];Cardiac output as assessed on cardiac magnetic resonance imaging[Baseline, 8 and 18 weeks after randomistaion];BNP levels on blood test sample[Baseline, 8 and 18 weeks after randomistaion]