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ASPEN: Tadalafil in Aortic Stenosis

NCT01275339Phase 4

Key facts

Status: Terminated
Start: Dec 2012
Primary completion: Apr 2017
Countries: 1
Sponsor: Washington University School of Medicine
Modality: Small Molecules

Drugs: tadalafil
Conditions: aortic stenosis (AS)

Overview

Phase 4, randomised, double-blind trial of tadalafil in aortic stenosis (AS) (4 arms), sponsored by Washington University School of Medicine. Primary endpoint: Diastolic Function as Measured by Tissue Doppler e' at 6 months. Started Dec 2012; status: terminated.

Design

4 arms

Study design: RandomizedDouble-blind

Tadalafil (Diabetic)
Tadalafil in diabetic cohort
Placebo (Diabetic)
Placebo in diabetic cohort
Tadalafil (Non-Diabetic)
Tadalafil in non-diabetic cohort
Placebo (Non-Diabetic)
Placebo in non-diabetic cohort

Who it enrols

Patients with moderate to severe aortic stenosis (AVA < 1.5 cm2), LV hypertrophy, diastolic dysfunction (e' <= 7 cm/s), and preserved EF (>= 50%).

Endpoints

Primary

Diastolic Function as Measured by Tissue Doppler e'6 months

Secondary

Change in Myocardial Fibrosis (ECV) on MRI6 months
Change in Other Echocardiographic Indices of Diastolic Function6 months
Safety and Tolerability6 months
Change in Indices of Systolic Function6 months
Change in LV Hypertrophic Remodeling6 months
Change in 6 Minute Walk Distance6 months
Change in Circulating Neurohormonal Markers6 months
Change in Quality of Life6 months

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