NCT00181259

Brief Summary

The metabolism of the heart provides the chemical energy needed to fuel ongoing normal heart contraction. Magnetic resonance spectroscopy is a technique used in a MRI scanner that can be used to measure and study heart metabolism directly but without blood sampling or obtaining tissue biopsies. One of the hypotheses this study aims to investigate is whether energy metabolism is reduced in heart failure and whether that contributes to the poor heart function.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Jan 1988

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress95%
Jan 1988Aug 2028

Study Start

First participant enrolled

January 1, 1988

Completed
17.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
21.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

39.6 years

First QC Date

September 13, 2005

Last Update Submit

March 6, 2026

Conditions

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

  • Phosphocreatine/adenosine triphosphate (PCr/ATP) and creatine kinase (CK) flux

    Can non-invasive magnetic resonance imaging and spectroscopy techniques be developed, validated, and implemented on clinical MR scanners in order to address the questions of a.) the extent to which myocardial high-energy phosphate (HEP), creatine (Cr), or sodium concentrations change in response to and after transient ischemia or chronic ischemic injury, b.) the extent to which myocardial high-energy phosphates, creatine, or sodium concentrations as well as HEP flux are altered in cardiomyopathic patients with and without/ congestive heart failure, c.) can spatial differences in cardiac metabolites (HEP, Cr) or ions (Na) induced by ischemic injury be identified with novel, non-invasive imaging techniques?

    At time of magnetic resonance spectroscopy (MRS)

Secondary Outcomes (8)

  • Phosphocreatine (PCr)

    At time of MRS

  • ATP

    At time of MRS

  • [Cr] or total creatine (CR), or CR/water ratio

    At time of MRS

  • Sodium (NA)

    At time of MRS

  • ATP flux

    At time of MRS

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with coronary artery disease, dilated cardiomyopathy, or left ventricular hypertrophy

You may qualify if:

  • age \> 18 years
  • Healthy subjects: no history of heart disease
  • Dilated cardiomyopathy: history of heart failure, ejection fraction (EF) \<40%
  • Left ventricular hypertrophy: wall thickness \>1.2cm
  • Coronary artery disease: \>50% coronary lesion or positive stress test

You may not qualify if:

  • contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (3)

  • Keceli G, Gupta A, Sourdon J, Gabr R, Schar M, Dey S, Tocchetti CG, Stuber A, Agrimi J, Zhang Y, Leppo M, Steenbergen C, Lai S, Yanek LR, O'Rourke B, Gerstenblith G, Bottomley PA, Wang Y, Paolocci N, Weiss RG. Mitochondrial Creatine Kinase Attenuates Pathologic Remodeling in Heart Failure. Circ Res. 2022 Mar 4;130(5):741-759. doi: 10.1161/CIRCRESAHA.121.319648. Epub 2022 Feb 3.

    PMID: 35109669DERIVED

  • Solaiyappan M, Weiss RG, Bottomley PA. Neural-network classification of cardiac disease from 31P cardiovascular magnetic resonance spectroscopy measures of creatine kinase energy metabolism. J Cardiovasc Magn Reson. 2019 Aug 12;21(1):49. doi: 10.1186/s12968-019-0560-5.

    PMID: 31401975DERIVED

  • Gabr RE, El-Sharkawy AM, Schar M, Panjrath GS, Gerstenblith G, Weiss RG, Bottomley PA. Cardiac work is related to creatine kinase energy supply in human heart failure: a cardiovascular magnetic resonance spectroscopy study. J Cardiovasc Magn Reson. 2018 Dec 10;20(1):81. doi: 10.1186/s12968-018-0491-6.

    PMID: 30526611DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Robert G. Weiss, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert G. Weiss, MD

CONTACT

410-955-1703rweiss@jhmi.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

January 1, 1988

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)