Heart Failure, CongestiveNCT00181259
Magnetic Resonance Spectroscopy Studies of Cardiac Muscle Metabolism
An observational study of Heart Failure, Congestive, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Congestive
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1988to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with coronary artery disease, dilated cardiomyopathy, or left ventricular hypertrophy
Who may be able to join
- 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
Who cannot join
- contraindication to MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21205
Tricia Steinberg, RN, MSN, 443-287-3469, asteinb3@jhmi.edu
About this study
Official title: In Vivo Cardiac Metabolism in Normal, Ischemic, and Cardiomyopathic Patients During Rest and Stress
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.
Read the detailed description
This study uses magnetic resonance (MR) spectroscopy to study heart metabolism and function in normal subjects and patients with left ventricular hypertrophy, dilated cardiomyopathy, and those with coronary artery disease.
- Conditions
- Heart Failure, Congestive
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: At time of magnetic resonance spectroscopy (MRS)
Secondary outcomes (8)
Phosphocreatine (PCr)
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?
Measured: At time of MRS
ATP
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?
Measured: At time of MRS
[Cr] or total creatine (CR), or CR/water ratio
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?
Measured: At time of MRS
Sodium (NA)
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?
Measured: At time of MRS
ATP 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?
Measured: At time of MRS
31P distribution or metabolite map
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?
Measured: At time of MRS
23Na distribution or metabolite map
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?
Measured: At time of MRS
CR distribution or metabolite map
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?
Measured: At time of MRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 1988
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Robert G. Weiss, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181259
- Sponsor's protocol ID
- NA_00044690
- Other IDs
- R01HL061912-14
- Status last verified
- Mar 2026
- First submitted
- 13 Sep 2005
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35109669Solaiyappan 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.
PubMed 31401975Gabr 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.
PubMed 30526611
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Cardiac Metabolism in Normal, Ischemic, and Cardiomyopathic Patients During Rest and Stress
- ClinicalTrials.gov ID
- NCT00181259
- Acronym / sponsor ID
- NA_00044690
- Conditions
- Heart Failure, Congestive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 1988
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study uses magnetic resonance (MR) spectroscopy to study heart metabolism and function in normal subjects and patients with left ventricular hypertrophy, dilated cardiomyopathy, and those with coronary artery disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease, dilated cardiomyopathy, or left ventricular hypertrophy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phosphocreatine/adenosine triphosphate (PCr/ATP) and creatine kinase (CK) flux
Time frame: At time of magnetic resonance spectroscopy (MRS)
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?
8 secondary outcomes
Phosphocreatine (PCr)
Time frame: At time of MRS
ATP
Time frame: At time of MRS
[Cr] or total creatine (CR), or CR/water ratio
Time frame: At time of MRS
Sodium (NA)
Time frame: At time of MRS
ATP flux
Time frame: At time of MRS
31P distribution or metabolite map
Time frame: At time of MRS
23Na distribution or metabolite map
Time frame: At time of MRS
CR distribution or metabolite map
Time frame: At time of MRS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Derived from this study: PubMed 35109669Keceli 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.
- Derived from this study: PubMed 31401975Solaiyappan 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.
- Derived from this study: PubMed 30526611Gabr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert G. Weiss, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Congestive, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert G. Weiss, MD (410-955-1703, rweiss@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phosphocreatine/adenosine triphosphate (PCr/ATP) and creatine kinase (CK) flux (time frame: At time of magnetic resonance spectroscopy (MRS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00181259, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.