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Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension

V

Vall d'Hebron University Hospital (HUVH)

Status and phase

Unknown
Phase 3

Conditions

Pulmonary Hypertension

Treatments

Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous

Study type

Interventional

Funder types

Other

Identifiers

NCT01091012
2009-012005-19 (EudraCT Number)
DOM-SIL-2009

Details and patient eligibility

About

The main objective is to validate the safety and efficacy of intravenous and oral sildenafil in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary hypertension after valvular surgery successfully, with a correct left ventricular function and no valvular disease hemodynamically significant.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients clinically stable, at least 1 year after the completion of successful valve surgery, with persistent pulmonary artery systolic pressure> 50 mmHg,
  • normal left ventricular function and no significant valvular disease in 2 separate Doppler ultrasound studies at least 1 month.

Exclusion criteria

  • Patients with other cardiac and noncardiac diseases will be excluded.

Trial design

30 participants in 2 patient groups

Sildenafil 20mg oral
Other group
Treatment:
Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous
Sildenafil 10mg intravenous
Other group
Treatment:
Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous

Trial contacts and locations

1

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Central trial contact

Enric Domingo, Promotor

Data sourced from clinicaltrials.gov

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