Trial Outcomes & Findings for Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels (NCT NCT00987415)
NCT ID: NCT00987415
Last Updated: 2014-11-04
Results Overview
CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
253 participants
Primary outcome timeframe
24 Weeks
Results posted on
2014-11-04
Participant Flow
Participant milestones
| Measure |
Allopurinol
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Sugar Pill
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
125
|
|
Overall Study
COMPLETED
|
119
|
116
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels
Baseline characteristics by cohort
| Measure |
Allopurinol
n=128 Participants
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Sugar Pill
n=125 Participants
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 14.2 • n=93 Participants
|
61.8 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
61.9 years
STANDARD_DEVIATION 13.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
208 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
169 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=93 Participants
|
124 Participants
n=4 Participants
|
250 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=93 Participants
|
92 participants
n=4 Participants
|
184 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
36 participants
n=93 Participants
|
33 participants
n=4 Participants
|
69 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksCCE composed of 3-level categorical variable with options that include worsened, unchanged or improved
Outcome measures
| Measure |
Allopurinol
n=128 Participants
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Sugar Pill
n=125 Participants
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
|---|---|---|
|
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
Improved
|
16 participants
|
24 participants
|
|
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
Worsened
|
58 participants
|
58 participants
|
|
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
Unchanged
|
54 participants
|
43 participants
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Participants analyzed included those patients who had complete data for this endpoint.
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.
Outcome measures
| Measure |
Allopurinol
n=120 Participants
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Sugar Pill
n=112 Participants
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
|---|---|---|
|
Change in Quality of Life (KCCQ).
|
4.45 units on a scale
Standard Deviation 15.42
|
3.38 units on a scale
Standard Deviation 19.43
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Participants analyzed included those patients who had complete data for this endpoint.
6-Minute Walk Test
Outcome measures
| Measure |
Allopurinol
n=107 Participants
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Sugar Pill
n=104 Participants
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
|---|---|---|
|
Change in Submaximal Exercise Capacity (6-MWT)
|
9.5 meters
Standard Deviation 77.2
|
9.5 meters
Standard Deviation 83.5
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Participants analyzed included those patients who had complete data for this endpoint.
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.
Outcome measures
| Measure |
Allopurinol
n=118 Participants
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Sugar Pill
n=111 Participants
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
|---|---|---|
|
Change in Quality of Life (KCCQ)
|
1.13 units on a scale
Standard Deviation 18.89
|
4.68 units on a scale
Standard Deviation 21.02
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Participants analyzed included those patients who had complete data for this endpoint.
6-Minute Walk Test
Outcome measures
| Measure |
Allopurinol
n=108 Participants
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Sugar Pill
n=94 Participants
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
|---|---|---|
|
Change in Submaximal Exercise Capacity (6-MWT)
|
18.1 meters
Standard Deviation 86.4
|
20.7 meters
Standard Deviation 86.0
|
Adverse Events
Allopurinol
Serious events: 25 serious events
Other events: 88 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 19 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allopurinol
n=128 participants at risk
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Sugar Pill
n=125 participants at risk
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorhage
|
2.3%
3/128
|
0.00%
0/125
|
|
Infections and infestations
Cellulitis
|
1.6%
2/128
|
0.00%
0/125
|
|
Infections and infestations
Pneumonia
|
3.1%
4/128
|
0.80%
1/125
|
|
Investigations
Anticoagulation Drug Level above Therapeutic
|
1.6%
2/128
|
1.6%
2/125
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/128
|
1.6%
2/125
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.6%
2/128
|
0.00%
0/125
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
2/128
|
0.00%
0/125
|
|
Vascular disorders
Hypertension
|
1.6%
2/128
|
2.4%
3/125
|
|
Gastrointestinal disorders
Pancreatitis
|
0.78%
1/128
|
0.80%
1/125
|
|
Infections and infestations
Sepsis
|
0.78%
1/128
|
0.80%
1/125
|
|
Infections and infestations
Postoperative wound infection
|
0.78%
1/128
|
0.80%
1/125
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.78%
1/128
|
0.80%
1/125
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.78%
1/128
|
0.80%
1/125
|
|
Gastrointestinal disorders
Diarhea
|
0.78%
1/128
|
0.00%
0/125
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.78%
1/128
|
0.00%
0/125
|
|
General disorders
Device dislocation
|
0.78%
1/128
|
0.00%
0/125
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/128
|
0.80%
1/125
|
|
Infections and infestations
Wound infection
|
0.00%
0/128
|
0.80%
1/125
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/128
|
0.80%
1/125
|
|
Metabolism and nutrition disorders
Diabeties Mellitus inadequate control
|
0.00%
0/128
|
0.80%
1/125
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/128
|
0.80%
1/125
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/128
|
0.80%
1/125
|
Other adverse events
| Measure |
Allopurinol
n=128 participants at risk
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Sugar Pill
n=125 participants at risk
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
2.3%
3/128
|
2.4%
3/125
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.78%
1/128
|
1.6%
2/125
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/128
|
3.2%
4/125
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
2/128
|
1.6%
2/125
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.6%
11/128
|
2.4%
3/125
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
3/128
|
0.80%
1/125
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.9%
5/128
|
1.6%
2/125
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
4/128
|
1.6%
2/125
|
|
Gastrointestinal disorders
Nausea
|
3.1%
4/128
|
1.6%
2/125
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/128
|
0.80%
1/125
|
|
General disorders
Fatigue
|
1.6%
2/128
|
1.6%
2/125
|
|
General disorders
Non-cardiac chest pain
|
2.3%
3/128
|
0.80%
1/125
|
|
Infections and infestations
Bronchitis
|
1.6%
2/128
|
0.80%
1/125
|
|
Infections and infestations
Cellulitis
|
2.3%
3/128
|
0.80%
1/125
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
3/128
|
1.6%
2/125
|
|
Infections and infestations
Pneumonia
|
1.6%
2/128
|
1.6%
2/125
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
3/128
|
2.4%
3/125
|
|
Infections and infestations
Urinary tract infection
|
1.6%
2/128
|
1.6%
2/125
|
|
Investigations
Blood creatinine increased
|
0.78%
1/128
|
2.4%
3/125
|
|
Metabolism and nutrition disorders
Gout
|
7.0%
9/128
|
9.6%
12/125
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/128
|
2.4%
3/125
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.3%
3/128
|
0.00%
0/125
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.3%
3/128
|
0.00%
0/125
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
5/128
|
3.2%
4/125
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
3/128
|
0.80%
1/125
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.3%
3/128
|
2.4%
3/125
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.7%
6/128
|
1.6%
2/125
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place