Trial Outcomes & Findings for Intravenous Allopurinol in Heart Failure (NCT NCT00181155)

Results Overview

Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Onset of imaging acquisition.

Results posted on

2017-05-30

Participant Flow

Participants with Non-Ischemic Cardiomyopathy were recruited as approved by the Johns Hopkins Institutional Review Board for Human Investigation.

The study drug allocation was randomized in a 4:1 fashion by the research pharmacy. Participants were randomized to Placebo only for the purposes of blinding; Adverse Events were collected for the Placebo arm.

Participant milestones

Participant milestones
Measure	Allopurinol Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.	Placebo Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
Overall Study STARTED	15	3
Overall Study COMPLETED	13	3
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Allopurinol Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.	Placebo Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Intravenous Allopurinol in Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Allopurinol n=13 Participants We randomized patients with nonischemic cardiomyopathy in a double-blind fashion to allopurinol (300 mg intravenously) or placebo infusion, 4-to-1, the latter for purposes of blinding only. The myocardial concentrations of ATP and creatine phosphate (PCr) and the rate of adenosine triphosphate (ATP) synthesis through CK (CK flux) were determined by 31-Phosphorus (31P) magnetic resonance spectroscopy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	47.8 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Onset of imaging acquisition.

Population: Data were analyzed for all participants who completed the MRS per protocol.

Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion

Outcome measures

Outcome measures
Measure	Baseline n=13 Participants Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion	2.07 umol/g/sec Standard Deviation 1.27

PRIMARY outcome

Timeframe: acute (within 15 minutes of single infusion)

Population: Data were analyzed for all participants who completed the MRS per protocol.

The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.

Outcome measures

Outcome measures
Measure	Baseline n=13 Participants Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
Myocardial CK Flux Post Intravenous Allopurinol Infusion.	2.87 umol/g/sec Standard Deviation 1.82

SECONDARY outcome

Timeframe: Onset of image acquisition.

Population: Data were analyzed for all participants who completed the MRS per protocol.

The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.

Outcome measures

Outcome measures
Measure	Baseline n=13 Participants Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
Cardiac PCr/ATP Pre Intravenous Infusion	1.58 ratio Standard Deviation 0.41

SECONDARY outcome

Timeframe: acute (within 15 minutes of single infusion)

Population: Data were analyzed for all participants who completed the MRS per protocol.

The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.

Outcome measures

Outcome measures
Measure	Baseline n=13 Participants Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
Cardiac PCr/ATP Post Intravenous Infusion	1.75 ratio Standard Deviation 0.59

Adverse Events

Arm 1 - Intravenous Allopurinol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 - Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert G. Weiss, MD

Johns Hopkins University

Phone: 410-955-1703

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place