NCT00353925

Brief Summary

The purpose of this study is to learn if kinase, a protein found in the heart, contributes to thickening of the heart muscle in people with high blood pressure. A protein called myosin causes the heart to contract and relax. It is thought that kinase changes myosin to make it work better at different heart rates. This study will try to determine if, in some people with high blood pressure, the different forms of this protein cause changes in the heart. If the protein affects the size of the heart, it might be possible to use it to improve heart function after an injury, such as a heart attack. African-Americans with high blood pressure will be eligible for this study. Current data show that of almost 900 multi-ethnic individuals, the particular form of kinase under study in this project is found exclusively in the African-American population. Study participants will have two tubes of blood drawn for DNA testing to determine what form of kinase is present. An electrocardiogram will also be done if a recent one is not available. Some people may also have an echocardiogram, an ultrasound test to image the heart.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

October 5, 1999

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2007

Completed
Last Updated

July 2, 2017

Status Verified

December 10, 2007

First QC Date

July 18, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

HypertrophyLVHCardiacBlood PressurePapillary Muscle

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Afro-American patients with a history of hypertension
  • Age greater than or equal to 21 years old
  • Presence of the kinase allele (homo or heterozygous)
  • Ability to give informed consent.
  • All of the above as well as:
  • Left ventricular ejection fraction of less than 35% by any imaging technique.

You may not qualify if:

  • For subjects with Kinase Allele:
  • For Subjects without the kinase allele and Myopathy Cohort:
  • History of myocardial infarction
  • History of significant valve disease
  • History of primary hyperthropic or infiltrative cardiomyopathy
  • History of rheumatic heart disease
  • Chronic atrial arrhythmia, bundle branch block intraventricular conduction defect or definite myocardial infarction on EKG
  • Inability to perform a metabolic stress test
  • Inability to perform a cMRI
  • Poor echocardiographic windows precluding accurate analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201-1595, United States

Location

Related Publications (1)

  • Sahn DJ, DeMaria A, Kisslo J, Weyman A. Recommendations regarding quantitation in M-mode echocardiography: results of a survey of echocardiographic measurements. Circulation. 1978 Dec;58(6):1072-83. doi: 10.1161/01.cir.58.6.1072.

    PMID: 709763BACKGROUND

MeSH Terms

Conditions

HypertensionHypertrophy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 19, 2006

Study Start

October 5, 1999

Study Completion

December 10, 2007

Last Updated

July 2, 2017

Record last verified: 2007-12-10

Locations