Heart FailurePhase 2EXACT-HFNCT00987415
Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels
A Phase 2 study testing allopurinol and sugar pill in people with Heart Failure and Elevated Serum Uric Acid, run by Duke University at 10 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether allopurinol is effective in relieving symptoms of patients with heart failure and high blood uric acid levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Elevated Serum Uric Acid
- What is being tested?
- allopurinol and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 10 sitesin 2 countries
- Study dates
- May 2010to Jun 2014
- 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
- NYHA class II-IV heart failure due to ischemic or non-ischemic cardiomyopathy.
- Left ventricular ejection fraction ≤ 40% by echocardiography- Heart failure symptoms for 3 months despite standard treatment.
- Serum uric acid level ≥ 9.5 mg/dl.
- At least one of the following additional markers of increased risk: Hospitalization, ER visit or urgent clinic visit for heart failure requiring IV diuretics within the previous 12 months; Left ventricular ejection fraction ≤ 25; B-type natriuretic peptide level > 250 pg/ml
Who cannot join
- Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, biopsy-proven myocarditis, severe stenotic valvular disease, or complex congenital heart disease.
- Acute coronary syndrome, PCI or CABG within 3 months.
- Current ventricular assist device or ventricular assist device or heart transplant likely within the next 6 months.
- Uncontrolled hypertension (i.e., SBP > 170 mm Hg or DBP > 110 mm Hg)
- Serum creatinine > 3 mg/dL or estimated GFR < 20 ml/min.
- Evidence of active hepatitis with ALT and AST greater than 3x normal.
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- Any condition other than HF which could limit the ability to perform a 6-minute walk test
- Any diseases other than HF which are likely to alter the patient's global perception of status or quality of life over a period of 6 months.
- Receiving treatment with allopurinol currently or within 30 days, or having symptomatic hyperuricemia which requires treatment with allopurinol.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Morehouse School of Medicine
Atlanta, Georgia
Harvard University
Boston, Massachusetts
University of Vermont
Burlington, Vermont
University Hospitals-Case Medical Center
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina
Baylor College of Medicine
Houston, Texas
University of Minnesota
Minneapolis, Minnesota
Mayo Clinic
Rochester, Minnesota
Univ. of Utah Health Sciences Center
Salt Lake City, Utah
About this study
Official title: Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients
The purpose of this study is to determine whether allopurinol is effective in relieving symptoms of patients with heart failure and high blood uric acid levels.
- Conditions
- Heart Failure, Elevated Serum Uric Acid
- Being tested
- allopurinol, sugar pill
- 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
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pillDrug
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| allopurinol | Active comparator | Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks. Receives: Drug: allopurinol |
| sugar pill | Placebo comparator | Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks. Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved
Measured: 24 Weeks
Secondary outcomes (4)
Change in Quality of Life (KCCQ).
Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline to 12 weeks
Change in Submaximal Exercise Capacity (6-MWT)
6-Minute Walk Test
Measured: Baseline to 12 weeks
Change in Quality of Life (KCCQ)
Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline to 24 weeks
Change in Submaximal Exercise Capacity (6-MWT)
6-Minute Walk Test
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startMay 2010
- Primary completionDec 2013
- Study completionJun 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Eugene Braunwald, MD, Study chair, Harvard UniversityAlice Mascette, MD, Study director, National Heart, Lung, and Blood Institute (NHLBI)Adrian Hernandez, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987415
- Sponsor's protocol ID
- Pro00020011
- Other IDs
- 5U10HL084904
- Acronym
- EXACT-HF
- Status last verified
- Oct 2014
- First submitted
- 30 Sep 2009
- Last updated
- 4 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Givertz MM, Anstrom KJ, Redfield MM, Deswal A, Haddad H, Butler J, Tang WH, Dunlap ME, LeWinter MM, Mann DL, Felker GM, O'Connor CM, Goldsmith SR, Ofili EO, Saltzberg MT, Margulies KB, Cappola TP, Konstam MA, Semigran MJ, McNulty SE, Lee KL, Shah MR, Hernandez AF; NHLBI Heart Failure Clinical Research Network. Effects of Xanthine Oxidase Inhibition in Hyperuricemic Heart Failure Patients: The Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients (EXACT-HF) Study. Circulation. 2015 May 19;131(20):1763-71. doi: 10.1161/CIRCULATIONAHA.114.014536. Epub 2015 Apr 14.
PubMed 25986447Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.
PubMed 21849262
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00987415
- Acronym / sponsor ID
- EXACT-HF / Pro00020011
- Conditions
- Heart Failure, Elevated Serum Uric Acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Posted 20 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether allopurinol is effective in relieving symptoms of patients with heart failure and high blood uric acid levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allopurinol | Active comparator | Drug: allopurinolAllopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks. |
| sugar pill | Placebo comparator | Drug: sugar pillMatching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NYHA class II-IV heart failure due to ischemic or non-ischemic cardiomyopathy.
- Left ventricular ejection fraction ≤ 40% by echocardiography- Heart failure symptoms for 3 months despite standard treatment.
- Serum uric acid level ≥ 9.5 mg/dl.
- At least one of the following additional markers of increased risk: Hospitalization, ER visit or urgent clinic visit for heart failure requiring IV diuretics within the previous 12 months; Left ventricular ejection fraction ≤ 25; B-type natriuretic peptide level > 250 pg/ml
Key exclusion criteria (9 listed)
- Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, biopsy-proven myocarditis, severe stenotic valvular disease, or complex congenital heart disease.
- Acute coronary syndrome, PCI or CABG within 3 months.
- Current ventricular assist device or ventricular assist device or heart transplant likely within the next 6 months.
- Uncontrolled hypertension (i.e., SBP > 170 mm Hg or DBP > 110 mm Hg)
- Serum creatinine > 3 mg/dL or estimated GFR < 20 ml/min.
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 |
|---|---|---|
| allopurinolAllopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks. | Drug | allopurinol |
| sugar pillMatching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks. | Drug | sugar pill |
Primary outcome
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
Time frame: 24 Weeks
CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved
4 secondary outcomes
Change in Quality of Life (KCCQ).
Time frame: Baseline to 12 weeks
Change in Submaximal Exercise Capacity (6-MWT)
Time frame: Baseline to 12 weeks
Change in Quality of Life (KCCQ)
Time frame: Baseline to 24 weeks
Change in Submaximal Exercise Capacity (6-MWT)
Time frame: Baseline to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25986447Givertz MM, Anstrom KJ, Redfield MM, Deswal A, Haddad H, Butler J, Tang WH, Dunlap ME, LeWinter MM, Mann DL, Felker GM, O'Connor CM, Goldsmith SR, Ofili EO, Saltzberg MT, Margulies KB, Cappola TP, Konstam MA, Semigran MJ, McNulty SE, Lee KL, Shah MR, Hernandez AF; NHLBI Heart Failure Clinical Research Network. Effects of Xanthine Oxidase Inhibition in Hyperuricemic Heart Failure Patients: The Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients (EXACT-HF) Study. Circulation. 2015 May 19;131(20):1763-71. doi: 10.1161/CIRCULATIONAHA.114.014536. Epub 2015 Apr 14.
- Derived from this study: PubMed 21849262Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.
- Trial WebsiteLink provided by the sponsor.
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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.
Eugene Braunwald, MD study chair
Harvard University
Alice Mascette, MD study director
National Heart, Lung, and Blood Institute (NHLBI)
Adrian Hernandez, MD principal investigator
Duke University
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing allopurinol and sugar pill in people with Heart Failure and Elevated Serum Uric Acid, run by Duke University at 10 sites in 2 countries.
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 4 inclusion and 9 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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 20 Oct 2014). 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?
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged. (time frame: 24 Weeks). 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 NCT00987415, which also lists 2 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 4 Nov 2014.