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Impact of sildenafil on the ventriculo-arterial performance in fontan palliated patients

Sildenafil and ventriculo-arterial coupling in Fontan palliated patients. A noninvasive echocardiographic assessment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201202209092N1
Enrollment
23
Registered
2012-04-30
Start date
2011-03-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart disease circulatory disease. Other functional disturbances following cardiac surgery

Interventions

sildenafil 0.5mg/kg/q8hours for one week.
Treatment - Drugs
sildenafil 0.5mg/kg/q8hours for one week

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients aged =8 years with Fontan modification of ECTCPC, patients had NYHA function class of I , being stable for the past 6 months without the occurrence of new symptoms or any changes in their medication. Exclusion criteria: pulse oxymetry of <80%, systolic blood pressure of <75 mmHg, hepatic and renal dysfunction confirmed by laboratory examination, ophthalmic and auditory defect, hypersensivity to sildenafil, Fontan pathway obstruction detected by CT/MR imaging or angiography and recent use of sildenafi in the past 3 months, patients with residual cardiovascular defects such as coarctation, cardiac dysrhythmia or bradycardia, pregnant patients

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Elastance. Timepoint: at the onset and one week post sildenafil administration. Method of measurement: echocardiography.

Secondary

MeasureTime frame
Headache, flushing,vertigo,nausea and vomiting, abdominal pain, renal stone, photosensivity,rash,diarrhea ,hypotension, musle pain,tinnitus. Timepoint: at the onset and one week post sildenafil administration and surviellance of side effects during the one week period of study. Method of measurement: queries.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Shabanian

Cildren's Medical Center

rshabanian@yahoo.comrshabanian@gmail.comrzshabanian@sina.tums.ac.ir+98 21 6693 0635

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026