Viewing Study NCT00001878



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Study NCT ID: NCT00001878
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: Factors Contributing to Increased Left Ventricle Size in Patients With Abnormally Enlarged Hearts
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Contribution of Insulin-Like Growth Factor-I IGF-I and Its Binding Protein IGFBP3 to Increased Left Ventricular Mass in Familial Hypertrophic Cardiomyopathy Caused by Distinct Sarcomeric Mutations
Status: COMPLETED
Status Verified Date: 2002-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The human heart is divided into four chambers One of the four chambers the left ventricle is the chamber mainly responsible for pumping blood out of the heart into the circulation There is an inherited condition affecting the heart passed on through genetics hypertrophic cardiomyopathy HCM HCM causes the left ventricle to become abnormally enlarged left ventricular hypertrophy LVH

Some patients with the abnormal genes that may cause HCM do not have the characteristic LVH Approximately 20 - 40 of patients with the genetic abnormality missense mutation of genes encoding for sarcomeric protein actually have an enlarged left ventricle Because of this researchers believe there may be other factors along with the genetic abnormality that contribute to the development of HCM Researchers are interested in learning more about several factors they suspect may play a role in the development of HCM

Specifically researchers plan to study levels of a hormone and the protein it attaches to which may contribute to the development of an abnormally enlarged heart Insulin-like growth factor IGF-1 and insulin-like growth factor binding protein IGFBP work together with growth hormone GH in the development and maturation of many organ systems Previous studies have suggested that these hormones affect the development and function of the heart

Patients participating in this study will undergo a variety of tests including collection of blood samples echocardiogram of the heart treadmill exercise test and continuous electrical monitoring of heart activity Holter monitor
Detailed Description: Hypertrophic cardiomyopathy HCM is a genetic disease with an autosomal dominant pattern of inheritance which is characterized by left ventricular hypertrophy LVH HCM is often caused by missense mutations of genes that encode for sarcomeric proteins The LVH varies markedly in patients with identical sarcomeric gene mutations and notably 20 to 40 of subjects with disease mutation do not have LVH as assessed by echocardiography These findings suggest that other factors affect LV wall thickness in HCM We wish 1 to investigate the potential role of IGF-I and its binding protein IGFBP3 in determining increased LV mass in HCM caused by sarcomeric mutations and 2 to assess myocardial ultrasound backscatter exercise tolerance and propensity to arrhythmias in subjects who have inherited sarcomeric mutations but who do not have LVH

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
99-H-0058 None None None