Trial Outcomes & Findings for The Impact of Zinc Supplementation on Left Ventricular Function in Nonischemic Cardiomyopathy (NCT NCT00696410)
NCT ID: NCT00696410
Last Updated: 2017-11-06
Results Overview
The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times daily for 10 months. The change from baseline in markers of cardiac collagen turnover (PINP) in patients with systolic heart failure after 10 months of zinc acetate was measured and compared with a single measure from healthy controls.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Baseline (time 0) and after 10 months of Zinc Acetate.
Results posted on
2017-11-06
Participant Flow
Patient were mainly recruited from the University of Michigan outpatient Cardiovascular clinic. 10 healthy controls (to quantify "normal" values and QA laboratory results for novel measures) were recruited from the community via advertisement.
The study was intended to run for 6 months. After further discussion with experts in zinc therapy, we opted to extend the study to 10 months.
Participant milestones
| Measure |
Zinc Acetate
The intervention group consisted of patients with heart failure. Patients were given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
|
Control
The control group consistent of 10 persons without any known health conditions who provided laboratory samples at a single encounter to quantify "normal" values for the novel labs measured. No intervention was provided to the healthy controls.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
10
|
|
Overall Study
COMPLETED
|
25
|
10
|
|
Overall Study
NOT COMPLETED
|
13
|
0
|
Reasons for withdrawal
| Measure |
Zinc Acetate
The intervention group consisted of patients with heart failure. Patients were given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
|
Control
The control group consistent of 10 persons without any known health conditions who provided laboratory samples at a single encounter to quantify "normal" values for the novel labs measured. No intervention was provided to the healthy controls.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
Baseline Characteristics
The Impact of Zinc Supplementation on Left Ventricular Function in Nonischemic Cardiomyopathy
Baseline characteristics by cohort
| Measure |
Zinc Acetate
n=38 Participants
The intervention group consisted of patients with heart failure. Patients were given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
|
Controls
n=10 Participants
The control group consistent of 10 persons without any known health conditions who provided laboratory samples at a single encounter to quantify "normal" values for the novel labs measured. No intervention was provided to the healthy controls.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 11 • n=5 Participants
|
52 years
STANDARD_DEVIATION 8 • n=7 Participants
|
55 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 64 years
|
29 participants
n=5 Participants
|
10 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
9 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
18 participants
n=5 Participants
|
4 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
10 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (time 0) and after 10 months of Zinc Acetate.Population: Power was determined using prior studies examining the change in PINP and (separately) PIIINP in heart failure following administration of aldactone. Results below are PINP. For Controls, a single measure was obtained without further followup.
The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times daily for 10 months. The change from baseline in markers of cardiac collagen turnover (PINP) in patients with systolic heart failure after 10 months of zinc acetate was measured and compared with a single measure from healthy controls.
Outcome measures
| Measure |
CHF Patients With Zinc Acetate
n=25 Participants
The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
|
Healthy Controls
n=10 Participants
The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify "normal" values for the novel labs measured. No intervention was provided to the healthy controls. A single measure was obtained without further followup.
|
|---|---|---|
|
Change From Baseline in Markers of Cardiac Collagen Turnover (PINP) in Patients With Systolic Heart Failure and Compared With Healthy Controls.
PINP baseline (time 0)
|
48.1 ng/ml
Interval 41.6 to 68.0
|
48.1 ng/ml
Interval 41.6 to 59.4
|
|
Change From Baseline in Markers of Cardiac Collagen Turnover (PINP) in Patients With Systolic Heart Failure and Compared With Healthy Controls.
PINP after 10 mo therapy
|
39 ng/ml
Interval 31.0 to 53.0
|
—
|
SECONDARY outcome
Timeframe: Baseline (time 0) and 10 monthsPopulation: power calculation using prior studies of the above laboratories. For Controls, a single measure was obtained without further followup.
Change from baseline in serum isoprostane 10 months after Zn Acetate in patients with systolic heart failure and compared with a single measure in healthy subjects
Outcome measures
| Measure |
CHF Patients With Zinc Acetate
n=25 Participants
The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
|
Healthy Controls
n=10 Participants
The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify "normal" values for the novel labs measured. No intervention was provided to the healthy controls. A single measure was obtained without further followup.
|
|---|---|---|
|
Change From Baseline in Serum Isoprostane in Patients With Systolic Heart Failure
Isoprostane baseline
|
4.4 pg/ml
Interval 3.4 to 5.3
|
3.8 pg/ml
Interval 3.1 to 5.2
|
|
Change From Baseline in Serum Isoprostane in Patients With Systolic Heart Failure
Isoprostane 10 mo
|
4.4 pg/ml
Interval 3.3 to 5.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (time 0) and 10 monthsPopulation: Specimens from healthy controls were only analyzed at one time frame.
Change in PIIINP from baseline after 10 months of Zinc Acetate in patients with systolic heart failure and compared with a single measure in healthy controls
Outcome measures
| Measure |
CHF Patients With Zinc Acetate
n=24 Participants
The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
|
Healthy Controls
n=10 Participants
The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify "normal" values for the novel labs measured. No intervention was provided to the healthy controls. A single measure was obtained without further followup.
|
|---|---|---|
|
Change in PIIINP From Baseline After 10 Months of Zinc Acetate in Systolic Heart Failure and Compared With a Single Measure in Healthy Controls
PIIINP baseline
|
5.3 ng/ml
Interval 4.1 to 6.1
|
4.1 ng/ml
Interval 3.1 to 4.5
|
|
Change in PIIINP From Baseline After 10 Months of Zinc Acetate in Systolic Heart Failure and Compared With a Single Measure in Healthy Controls
PIIINP 10 months
|
5.3 ng/ml
Interval 2.6 to 9.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (time 0) and 10 monthsPopulation: Specimens from healthy controls were only analyzed at one time frame.
Change from baseline in serum superoxide dismutase after 10 months of zinc acetate in patients with systolic heart failure and compared with a single measure in healthy controls
Outcome measures
| Measure |
CHF Patients With Zinc Acetate
n=25 Participants
The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
|
Healthy Controls
n=10 Participants
The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify "normal" values for the novel labs measured. No intervention was provided to the healthy controls. A single measure was obtained without further followup.
|
|---|---|---|
|
Change From Baseline in Serum Superoxide Dismutase
SOD at Baseline
|
160 units per microL
Interval 88.0 to 261.0
|
117 units per microL
Interval 40.0 to 262.0
|
|
Change From Baseline in Serum Superoxide Dismutase
SOD at 10 months
|
151 units per microL
Interval 31.0 to 785.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (time 0) and 10 monthsPopulation: Healthy controls only analyzed at one time point
Change from baseline in serum myeloperoxidase (MPO) after 10 months of zinc acetate treatment in patients with systolic heart failure and compared with a single measure from healthy controls
Outcome measures
| Measure |
CHF Patients With Zinc Acetate
n=24 Participants
The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
|
Healthy Controls
n=10 Participants
The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify "normal" values for the novel labs measured. No intervention was provided to the healthy controls. A single measure was obtained without further followup.
|
|---|---|---|
|
Change From Baseline in Serum Measures of of Myeloperoxidase (MPO) After 10 Months of Zinc Acetate Treatment
MPO baseline (time 0)
|
455 units per L
Interval 286.0 to 1212.0
|
295 units per L
Interval 145.0 to 1061.0
|
|
Change From Baseline in Serum Measures of of Myeloperoxidase (MPO) After 10 Months of Zinc Acetate Treatment
MPO at 10 months
|
816 units per L
Interval 169.0 to 6294.0
|
—
|
Adverse Events
HF Group
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HF Group
n=38 participants at risk
The zinc intervention group consisted of patients with heart failure who were provided zinc acetate for 10 months
|
Healthy Controls
n=10 participants at risk
The control group consisted of 10 persons without any known health conditions who provided laboratory samples to quantify "normal" values for the novel labs measured. No intervention was provided to the healthy controls
|
|---|---|---|
|
Cardiac disorders
Intracoronary stent
|
2.6%
1/38 • Number of events 3 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
0.00%
0/10 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
|
Injury, poisoning and procedural complications
Nonelective Hospitalization- accident
|
2.6%
1/38 • Number of events 3 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
0.00%
0/10 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
|
Cardiac disorders
Nonelective Hospitalization- CHF exacerbation
|
2.6%
1/38 • Number of events 3 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
0.00%
0/10 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
Other adverse events
| Measure |
HF Group
n=38 participants at risk
The zinc intervention group consisted of patients with heart failure who were provided zinc acetate for 10 months
|
Healthy Controls
n=10 participants at risk
The control group consisted of 10 persons without any known health conditions who provided laboratory samples to quantify "normal" values for the novel labs measured. No intervention was provided to the healthy controls
|
|---|---|---|
|
Nervous system disorders
dizziness
|
2.6%
1/38 • Number of events 2 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
0.00%
0/10 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
|
General disorders
Odd taste in mouth
|
2.6%
1/38 • Number of events 2 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
0.00%
0/10 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
|
Gastrointestinal disorders
Nausea
|
15.8%
6/38 • Number of events 6 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
0.00%
0/10 • Adverse event occurrences were captured at each follow-up visit and when notified by patients or patient's practitioner (if occurring outside of a standard follow-up visit).
|
Additional Information
Jennifer Cowger, MD, Assistant Professor
University of Michigan
Phone: 734 936-5265
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place