Congestive Heart FailurePhase 2NCT00181155
Intravenous Allopurinol in Heart Failure
A Phase 2 study testing Allopurinol in people with Congestive Heart Failure, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Allopurinol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- The patient is willing and able to provide informed consent
- Clinical diagnosis of chronic heart failure
- Ejection fraction (EF) < 40% by echocardiography, nuclear multigated acquisition (MUGA) or cath ventriculography
- No significant coronary disease at cardiac catheterization
- New York Heart Association (NYHA) Class I-IV symptoms
- Clinical stabilization for two weeks if following recent congestive heart failure (CHF) decompensation.
Who cannot join
- Metallic implant prohibiting magnetic resonance (MR) evaluation
- Inability to lie flat for MR study
- Administration of additional investigational drugs
- Calculated creatinine clearance < 50 mL/min
- Allergy to allopurinol
- Current gout flare
- Currently taking oral allopurinol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Xanthine Oxidase Inhibition on Mechano-Energetic Coupling in Heart Failure
This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.
Read the detailed description
Xanthine oxidase have been reported to improve mechano-energetic coupling in failing hearts. The investigators developed a means to directly measure creatine kinase flux, the major energy reserve of the heart, in the human heart exploiting new magnetic resonance technologies.
The investigators propose to study 10 healthy subjects and up to 25 with heart failure (dilated cardiomyopathy) before and after a single 300mg IV infusion of allopurinol.
- Conditions
- Congestive Heart Failure
- Being tested
- Allopurinol, Placebo
- Keywords
- metabolism, congestive heart failure, allopurinol, Adenosine triphosphate (ATP)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called Aloprim
intravenous infusion of allopurinol (300mg)
PlaceboDrug
Also called 5% Dextrose
intravenous infusion of 50 ml dose of 5% dextrose
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Experimental | One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes. Receives: Drug: Allopurinol |
| Placebo | Placebo comparator | One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion
Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion
Measured: Onset of imaging acquisition.
Myocardial CK Flux Post Intravenous Allopurinol Infusion.
The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.
Measured: acute (within 15 minutes of single infusion)
Secondary outcomes (2)
Cardiac PCr/ATP Pre Intravenous Infusion
The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.
Measured: Onset of image acquisition.
Cardiac PCr/ATP Post Intravenous Infusion
The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.
Measured: acute (within 15 minutes of single infusion)
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 startNov 2004
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Robert G. Weiss, Johns Hopkins University
- Investigators
- Robert G Weiss, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181155
- Sponsor's protocol ID
- IRB: 04-10-12-06
- Other IDs
- 5R01HL061912-14
- Status last verified
- Apr 2017
- First submitted
- 12 Sep 2005
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hirsch GA, Bottomley PA, Gerstenblith G, Weiss RG. Allopurinol acutely increases adenosine triphospate energy delivery in failing human hearts. J Am Coll Cardiol. 2012 Feb 28;59(9):802-8. doi: 10.1016/j.jacc.2011.10.895.
PubMed 22361399
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Xanthine Oxidase Inhibition on Mechano-Energetic Coupling in Heart Failure
- ClinicalTrials.gov ID
- NCT00181155
- Acronym / sponsor ID
- IRB: 04-10-12-06
- Conditions
- Congestive Heart Failure
- Keywords
- metabolism, congestive heart failure, allopurinol, Adenosine triphosphate (ATP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 9 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.
Detailed description
Xanthine oxidase have been reported to improve mechano-energetic coupling in failing hearts. The investigators developed a means to directly measure creatine kinase flux, the major energy reserve of the heart, in the human heart exploiting new magnetic resonance technologies.
The investigators propose to study 10 healthy subjects and up to 25 with heart failure (dilated cardiomyopathy) before and after a single 300mg IV infusion of allopurinol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Experimental | Drug: AllopurinolOne time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes. |
| Placebo | Placebo comparator | Drug: PlaceboOne time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- The patient is willing and able to provide informed consent
- Clinical diagnosis of chronic heart failure
- Ejection fraction (EF) < 40% by echocardiography, nuclear multigated acquisition (MUGA) or cath ventriculography
- No significant coronary disease at cardiac catheterization
Key exclusion criteria (7 listed)
- Metallic implant prohibiting magnetic resonance (MR) evaluation
- Inability to lie flat for MR study
- Administration of additional investigational drugs
- Calculated creatinine clearance < 50 mL/min
- Allergy to allopurinol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllopurinolAlso: Aloprimintravenous infusion of allopurinol (300mg) | Drug | Allopurinol |
| PlaceboAlso: 5% Dextroseintravenous infusion of 50 ml dose of 5% dextrose | Drug | Placebo |
Primary outcome
Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion
Time frame: Onset of imaging acquisition.
Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion
Myocardial CK Flux Post Intravenous Allopurinol Infusion.
Time frame: acute (within 15 minutes of single infusion)
The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.
2 secondary outcomes
Cardiac PCr/ATP Pre Intravenous Infusion
Time frame: Onset of image acquisition.
Cardiac PCr/ATP Post Intravenous Infusion
Time frame: acute (within 15 minutes of single infusion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22361399Hirsch GA, Bottomley PA, Gerstenblith G, Weiss RG. Allopurinol acutely increases adenosine triphospate energy delivery in failing human hearts. J Am Coll Cardiol. 2012 Feb 28;59(9):802-8. doi: 10.1016/j.jacc.2011.10.895.
- 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. This study is not recruiting at the moment.
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?
A Phase 2 study testing Allopurinol in people with Congestive Heart Failure, 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 30 May 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion (time frame: Onset of imaging acquisition.). The study lists 2 primary outcomes in all. 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 NCT00181155, which also lists 1 linked publication.
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 30 May 2017.