Trial Outcomes & Findings for Influence of Genetic Polymorphisms on Ventricular Structure and Function in Patients With Single Ventricle Anatomy (NCT NCT00165984)

Results Overview

Recruitment status

COMPLETED

Target enrollment

224 participants

Primary outcome timeframe

7 years

Results posted on

2012-05-02

Participant milestones
Measure	Single Ventricle Patients Patients born with single ventricle heart disease
Overall Study STARTED	165
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	15

Reasons for withdrawal
Measure	Single Ventricle Patients Patients born with single ventricle heart disease
Overall Study Death	15

Influence of Genetic Polymorphisms on Ventricular Structure and Function in Patients With Single Ventricle Anatomy

Baseline characteristics by cohort
Measure	Single Ventricle Patients n=165 Participants Patients born with single ventricle heart disease
Age, Categorical <=18 years	165 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	7 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants
Region of Enrollment United States	165 participants n=5 Participants

Timeframe: 7 years

Population: 165 enrolled patients were analyzed for this polymorphism

Outcome measures
Measure	Incidence of Preproendothelin-1 5665 Polymorphism n=165 Participants Incidence of Homozygosity for mutation at nucleotide 5665	Homozygous for Wild-type ppET1 5665 Transplant-free survival for patients homozygous for G at nucleotide 5665 at 7 years.	Heterozygotes Transplant-free survival for patients heterozygous (G/T) at nucleotide 5665 at 7 years.
To Evaluate the Incidence of the Pre-proendothelin SNP at Nucleotide 5665	10 participants	—	—

Timeframe: 7 yr mean follow-up

Population: All patients enrolled were genotyped

Follow-up study designed to determine the impact of genetic factors on survival in single ventricle patients

Outcome measures
Measure	Incidence of Preproendothelin-1 5665 Polymorphism n=10 Participants Incidence of Homozygosity for mutation at nucleotide 5665	Homozygous for Wild-type ppET1 5665 n=103 Participants Transplant-free survival for patients homozygous for G at nucleotide 5665 at 7 years.	Heterozygotes n=52 Participants Transplant-free survival for patients heterozygous (G/T) at nucleotide 5665 at 7 years.
Survival	40 percentage of patients alive/nontrans Interval 10.0 to 10.0	80 percentage of patients alive/nontrans	88 percentage of patients alive/nontrans

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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