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Trial Outcomes & Findings for Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP) (NCT NCT00308230)

NCT ID: NCT00308230

Last Updated: 2014-07-17

Results Overview

Levels of B-type naturietic peptide in the blood

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

1 day

Results posted on

2014-07-17

Participant Flow

medical specialty clinic

No washout or run-in period. Participants were stable Ambulatory outpatients with no changes in their medical regimen for prior to enrollment. Exclusions included inability to complete a six minute walk, inability to cooperate with instructions, congenital diagnosis other than the three listed in the CHD group (TOF, DTGA, CCTGA)

Participant milestones

Participant milestones
Measure
Control Group
Structurally normal heart without heart disease.
Congenital Heart Disease
Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
Heart Failure
Acquired left ventricular heart failure, no history of congenital heart disease
Overall Study
STARTED
6
8
20
Overall Study
COMPLETED
6
8
20
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=6 Participants
Structurally normal heart without heart disease
Congenital Heart Disease
n=8 Participants
Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
Heart Failure
n=20 Participants
Acquired left ventricular heart failure, no history of congenital heart disease
Total
n=34 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=5 Participants
8 Participants
n=7 Participants
20 Participants
n=5 Participants
34 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
11 Participants
n=4 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
5 Participants
n=7 Participants
16 Participants
n=5 Participants
23 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 1 day

Levels of B-type naturietic peptide in the blood

Outcome measures

Outcome measures
Measure
Control Group
n=6 Participants
Structurally normal hearts
Congenital Heart Disease
n=8 Participants
TOF, DTGA, CCTGA-tetralogy of Fallot, the transposition of the great arteries, congenitally corrected transposition
Heart Failure
n=20 Participants
Left ventricular failure
BNP Levels
16.3 pg/ml
Standard Deviation 17.3
42.4 pg/ml
Standard Deviation 44.8
384.3 pg/ml
Standard Deviation 452.8

Adverse Events

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Congenital Heart Disease

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Heart Failure

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wendy Book

Emory University

Phone: 404-778-5545

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place