Trial · NCT02314780
The Effects of Intravenous Heme Arginate on Heme Oxygenase-1 Expression (HO-1) and Oxidative Stress in the Human Heart
NCT02314780, Phase 2, Completed, Martin Andreas, M.D.; results first posted 2021-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of Intravenous Heme Arginate on Heme Oxygenase-1 Expression (HO-1) and Oxidative Stress in the Human Heart. Trials, record NCT02314780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02314780
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Intravenous Heme Arginate on Heme Oxygenase-1 Expression (HO-1) and Oxidative Stress in the Human Heart
- NCT number
- NCT02314780
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Martin Andreas, M.D.
- Conditions
- Myocardial Ischemia
- Interventions
- Heme arginate 3mg/kg, Heme arginate 1mg/kg, Placebo
- First posted
- 2014-12-11
- Last updated
- 2021-02-15
- Other registries' IDs
- eudract:2013-000887-27
- Results first posted
- 2021-02-15
- Limitations and caveats
Biopsy samples were small and protein concentration could not be measured in every sample. The sample size calculation was based on previous results but is small for a 3-arm randomized controlled trial. Additional surgical procedures might impact the postoperative course of cardiac enzymes and obscure a potential effect in this small group. This study was powered to identify protein expression in the heart but not to evaluate potential therapeutic effects.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Heme Oxygenase-1 (HO-1) Messenger Ribonucleic Acid (mRNA) Levels (Atrial Tissue) | intraoperative | The right atrial appendage was clamped and cut for cannulation before cardiopulmonary bypass. The tissue samples were snap-frozen in the operating theater after sampling. |
| Primary | Myocardial HO-1 mRNA Levels (Ventricular Tissue Before Aortic Cross-clamping) | intraoperative | A small biopsy was taken from the right ventricular free wall directly before aortic cross-clamping. The tissue samples were snap-frozen in the operating theater after sampling. |
| Primary | Myocardial HO-1 mRNA Levels (Ventricular Tissue After Aortic Cross-clamping) | intraoperative | A small biopsy was taken from the right ventricular free wall after aortic clamp release before weaning from cardiopulmonary bypass. The tissue samples were snap-frozen in the operating theater after sampling. |
| Primary | Myocardial HO-1 Protein Concentrations (Atrial Tissue) | intraoperative | The right atrial appendage was clamped and cut for cannulation before cardiopulmonary bypass.The tissue samples were snap-frozen. Western blot analysis was performed. The amount of HO-1 protein (quantified as pixels under the curve) was evaluated. |
| Primary | Myocardial HO-1 Protein Concentrations (Ventricular Tissue Before Aortic Cross-clamping) | intraoperative | A small biopsy was taken from the right ventricular free wall directly before aortic cross-clamping. The tissue samples were snap-frozen. Western blot analysis was performed. The amount of HO-1 protein (quantified as pixels under the curve) was evaluated. |
| Primary | Myocardial HO-1 Protein Concentrations (Ventricular Tissue After Aortic Cross-clamping) | intraoperative | A small biopsy was taken from the right ventricular free wall after aortic clamp release before weaning from cardiopulmonary bypass. The tissue samples were snap-frozen in the operating theater after sampling. Western blot analysis was performed. The amount of HO-1 protein (quantified as pixels under the curve) was evaluated. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Heme Oxygenase-1 (HO-1) Messenger Ribonucleic Acid (mRNA) Levels (Atrial Tissue) | intraoperative | arbitrary units | MEAN | |
| PRIMARY | Myocardial HO-1 mRNA Levels (Ventricular Tissue Before Aortic Cross-clamping) | intraoperative | arbitrary units | MEAN | |
| PRIMARY | Myocardial HO-1 mRNA Levels (Ventricular Tissue After Aortic Cross-clamping) | intraoperative | arbitrary units | MEAN | |
| PRIMARY | Myocardial HO-1 Protein Concentrations (Atrial Tissue) | intraoperative | pixels under the curve | MEAN | |
| PRIMARY | Myocardial HO-1 Protein Concentrations (Ventricular Tissue Before Aortic Cross-clamping) | intraoperative | pixels under the curve | MEAN | |
| PRIMARY | Myocardial HO-1 Protein Concentrations (Ventricular Tissue After Aortic Cross-clamping) | intraoperative | pixels under the curve | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Heme Oxygenase-1 (HO-1) Messenger Ribonucleic Acid (mRNA) Levels (Atrial Tissue) | Heme Arginate (High Dose) | 392.7 | Standard Deviation 195.7 | arbitrary units | |
| Heme Oxygenase-1 (HO-1) Messenger Ribonucleic Acid (mRNA) Levels (Atrial Tissue) | Heme Arginate (Low Dose) | 229.8 | Standard Deviation 173.1 | arbitrary units | |
| Heme Oxygenase-1 (HO-1) Messenger Ribonucleic Acid (mRNA) Levels (Atrial Tissue) | Placebo | 10.8 | Standard Deviation 8.8 | arbitrary units | |
| Myocardial HO-1 mRNA Levels (Ventricular Tissue Before Aortic Cross-clamping) | Heme Arginate (High Dose) | 203.6 | Standard Deviation 148.7 | arbitrary units | |
| Myocardial HO-1 mRNA Levels (Ventricular Tissue Before Aortic Cross-clamping) | Heme Arginate (Low Dose) | 88.6 | Standard Deviation 49.1 | arbitrary units | |
| Myocardial HO-1 mRNA Levels (Ventricular Tissue Before Aortic Cross-clamping) | Placebo | 7.9 | Standard Deviation 5.0 | arbitrary units | |
| Myocardial HO-1 mRNA Levels (Ventricular Tissue After Aortic Cross-clamping) | Heme Arginate (High Dose) | 219.4 | Standard Deviation 162.8 | arbitrary units | |
| Myocardial HO-1 mRNA Levels (Ventricular Tissue After Aortic Cross-clamping) | Heme Arginate (Low Dose) | 108.1 | Standard Deviation 73.2 | arbitrary units | |
| Myocardial HO-1 mRNA Levels (Ventricular Tissue After Aortic Cross-clamping) | Placebo | 8.3 | Standard Deviation 5.4 | arbitrary units | |
| Myocardial HO-1 Protein Concentrations (Atrial Tissue) | Heme Arginate (High Dose) | 29022 | Standard Deviation 8583 | pixels under the curve |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Heme Arginate (High Dose) | 9 | |
| Overall Study | STARTED | Heme Arginate (Low Dose) | 10 | |
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | COMPLETED | Heme Arginate (High Dose) | 9 | |
| Overall Study | COMPLETED | Heme Arginate (Low Dose) | 7 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Heme Arginate (High Dose) | 0 | |
| Overall Study | NOT COMPLETED | Heme Arginate (Low Dose) | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Procedural pneumothorax | Injury, poisoning and procedural complications | Heme Arginate (High Dose) | 0 | 9 | 0 |
| other | Procedural pneumothorax | Injury, poisoning and procedural complications | Heme Arginate (Low Dose) | 1 | 10 | 1 |
| other | Procedural pneumothorax | Injury, poisoning and procedural complications | Placebo | 0 | 8 | 0 |
| other | Blood culture positive | Investigations | Heme Arginate (High Dose) | 0 | 9 | 0 |
| other | Blood culture positive | Investigations | Heme Arginate (Low Dose) | 0 | 10 | 0 |
| other | Blood culture positive | Investigations | Placebo | 1 | 8 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Heme Arginate (High Dose) | 1 | 9 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Heme Arginate (Low Dose) | 3 | 10 | 3 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 3 | 8 | 3 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Heme Arginate (High Dose) | 0 | 9 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Heme Arginate (High Dose) | 0 | 9 |
| Total, all-cause mortality | Heme Arginate (Low Dose) | 0 | 10 |
| Total, all-cause mortality | Placebo | 0 | 8 |
| Total, other adverse events | Heme Arginate (High Dose) | 1 | 9 |
| Total, other adverse events | Heme Arginate (Low Dose) | 5 | 10 |
| Total, other adverse events | Placebo | 4 | 8 |
| Total, serious adverse events | Heme Arginate (High Dose) | 2 | 9 |
| Total, serious adverse events | Heme Arginate (Low Dose) | 0 | 10 |
| Total, serious adverse events | Placebo | 1 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30354231 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02314780
GET https://conductscience.org/api/trials/v1/NCT02314780/events?page=2