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Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function

NCT03049540 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-06-23

No results posted yet for this study

Summary

This study assesses in a double-blind, randomized, placebo-controlled multi-center pilot trial the effect of PDE-5 inhibition with Tadalafil on right ventricle size and function, exercise capacity and neurohumoral activation in adults with congenital heart disease and a right ventricle in subaortic position over a 3-year follow-up period.

Conditions

  • Heart Defects, Congenital
  • Transposition of Great Vessels With Ventricular Inversion

Interventions

DRUG

Tadalafil 20 MG

Multi-center, double-blind, 1:1 randomized, placebo-controlled clinical trial with Tadalafil

DRUG

Placebo 20 MG

Multi-center, double-blind, 1:1 randomized, placebo-controlled clinical trial with Tadalafil

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Markus Schwerzmann, MD · Bern University Hospital, Zentrum fuer angeborene Herzfehler

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2021-10-28
Completion
2021-10-28

Countries

  • Austria
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03049540 on ClinicalTrials.gov