To evaluate the impact of oral sildenafil on the ventriculo-arterial coupling in patients with Fontan circulation, we assessed a sample of 24 patients palliated with Fontan circulation in Children’s Medical center. Patients included should have stable condition in the past 6 months and were excluded in case of heart, hepatic or renal failure and sensitivity to sildenafil. Clinical characteristics and echocardiographic examination of ventricular and arterial elastances were performed before and after a one week course of sildenafil 0.5mg/kg/q8h. Moreover we monitored the possible side effects of sildenafil throughout the course of therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202209092N1
Registration date:2012-04-30, 1391/02/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-30, 1391/02/11
Registrant information
Name
Reza Shabanian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 0982
Email address
rzshabanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sildenafil and ventriculo-arterial coupling in Fontan palliated patients. A noninvasive echocardiographic assessment
Public title
Impact of sildenafil on the ventriculo-arterial performance in fontan palliated patients
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 8 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Researdh Deputy.Tehran University of Medical Sciences,
Street address
sixth floor ,Tehran university central organization, Ghods street ,Keshavarz Boulevard,tTehran,Iran
City
Tehran
Postal code
Approval date
2012-04-16, 1391/01/28
Ethics committee reference number
130/2648/د/90
Health conditions studied
1
Description of health condition studied
congenital heart disease circulatory disease
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
elastance
Timepoint
at the onset and one week post sildenafil administration