NCT00308230

Brief Summary

The object of this study is to measure the levels of B-type Natriuretic Peptide (BNP) in patients with congenital heart disease, normal individuals, and patients with acquired heart failure, and compare the results from each group.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2001

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
8.3 years until next milestone

Results Posted

Study results publicly available

July 17, 2014

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

2.2 years

First QC Date

March 27, 2006

Results QC Date

September 10, 2013

Last Update Submit

July 16, 2014

Conditions

Congenital Heart DiseaseCardiovascular Disease

Keywords

Congenital, BNP

Outcome Measures

Primary Outcomes (1)

  • BNP Levels

    Levels of B-type naturietic peptide in the blood

    1 day

Study Arms (3)

Normal Heart

PLACEBO COMPARATOR

Control Group with Normal Heart

Procedure: Six minute walk testBehavioral: Minnesota Living with Heart Failure Questionnaire

Congenital Heart Disease

ACTIVE COMPARATOR

Tetralogy of Fallot, DTGA, CCTGA

Procedure: Six minute walk testBehavioral: Minnesota Living with Heart Failure Questionnaire

Heart Failure

ACTIVE COMPARATOR

Left ventricular heart failure, no congestive heart disease

Procedure: Six minute walk testBehavioral: Minnesota Living with Heart Failure Questionnaire

Interventions

Six minute walk testPROCEDURE
Congenital Heart DiseaseHeart FailureNormal Heart
Minnesota Living with Heart Failure QuestionnaireBEHAVIORAL
Congenital Heart DiseaseHeart FailureNormal Heart

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Single ventricle and or single atria Liver disease with portal hypertension Renal disease requiring dialysis Creatine \> 4.0 Significant pulmonary hypertension (systolic PAP \>60 mmHg by Echo) Uncontrolled systemic arterial hypertension (systolic \> 200 mmHg or diastolic \>105 mmHg) Myocardial infarction or acute coronary syndrome within 2 months D-TGA status post atrial switch procedure (Jatene) Intracardiac shunts Inadequate echocardiogram windows Coronary Angioplasty 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Defects, CongenitalCardiovascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Wendy Book
Organization
Emory University
wbook@emory.edu
404-778-5545

Study Officials

  • Wendy M Book, M.D.

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 29, 2006

Study Start

December 1, 2001

Primary Completion

March 1, 2004

Study Completion

September 1, 2004

Last Updated

July 17, 2014

Results First Posted

July 17, 2014

Record last verified: 2014-07