NCT01110395

Brief Summary

Heart needs constant supply of energy to continue working. Phosphorus magnetic resonance spectroscopy allows us to measure energy produced in the heart. The purpose of this study is to determine if the energy production is reduced in failing heart.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

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

June 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

August 7, 2020

Completed
Last Updated

August 7, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

April 22, 2010

Results QC Date

February 7, 2018

Last Update Submit

July 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • An MR Spectroscopy Showing Signal to Noise Ratio to Determine the Level of Heart Failure

    1-2 days

Study Arms (1)

MR Spectroscopy Post-Heart Transplant

EXPERIMENTAL

Patients post heart transplant getting heart biopsy

Diagnostic Test: MR Spectroscopy

Interventions

MR SpectroscopyDIAGNOSTIC_TEST

MR spectroscopy of myocardial

MR Spectroscopy Post-Heart Transplant

Eligibility Criteria

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

You may qualify if:

  • Individuals with left ventricular dysfunction

You may not qualify if:

  • Age \< 18, pregnant, history of excessive alcohol use, or any condition (e.g. claustrophobia, a pacemaker) that would prevent him/her from completing the magnetic resonance spectroscopy study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

  • Lipskaya TY. Mitochondrial creatine kinase: properties and function. Biochemistry (Mosc). 2001 Oct;66(10):1098-111. doi: 10.1023/a:1012428812780.

    PMID: 11736631BACKGROUND
  • Nascimben L, Ingwall JS, Pauletto P, Friedrich J, Gwathmey JK, Saks V, Pessina AC, Allen PD. Creatine kinase system in failing and nonfailing human myocardium. Circulation. 1996 Oct 15;94(8):1894-901. doi: 10.1161/01.cir.94.8.1894.

    PMID: 8873665BACKGROUND
  • De Sousa E, Veksler V, Minajeva A, Kaasik A, Mateo P, Mayoux E, Hoerter J, Bigard X, Serrurier B, Ventura-Clapier R. Subcellular creatine kinase alterations. Implications in heart failure. Circ Res. 1999 Jul 9;85(1):68-76. doi: 10.1161/01.res.85.1.68.

    PMID: 10400912BACKGROUND
  • Nascimben L, Friedrich J, Liao R, Pauletto P, Pessina AC, Ingwall JS. Enalapril treatment increases cardiac performance and energy reserve via the creatine kinase reaction in myocardium of Syrian myopathic hamsters with advanced heart failure. Circulation. 1995 Mar 15;91(6):1824-33. doi: 10.1161/01.cir.91.6.1824.

    PMID: 7882493BACKGROUND

Related Links

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Limitations and Caveats

There were no limitations or caveats

Results Point of Contact

Title
Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory
Organization
Washington University School of Medicine

Study Officials

  • Adil Bashir, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2010

First Posted

April 26, 2010

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 7, 2020

Results First Posted

August 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations