Trial · NCT04269629
The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy
NCT04269629, Completed, Medical University of Graz; results first posted 2020-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy. Trials, record NCT04269629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04269629
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy
- NCT number
- NCT04269629
- Status
- Completed
- Enrollment
- 1,425 participants, actual
- Lead sponsor
- Medical University of Graz
- Conditions
- Hymenoptera Venom Allergy, Antihypertensive Treatment
- Interventions
- Insect Venom
- First posted
- 2020-02-17
- Last updated
- 2020-11-20
- Results first posted
- 2020-11-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT) | after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour | The primary objective of this study is to evaluate whether subjects under antihypertensive treatment with beta-blockers and/or angiotensin converting enzyme (ACE)-inhibitors show more side effects during VIT compared to subjects with no antihypertensive treatment. |
| Secondary | Severity of Sting Reactions | duration of first visit (~1hour) | To evaluate whether subjects under antihypertensive treatment with beta-blockers and/or ACE-inhibitors have more severe sting reactions. |
| Secondary | Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions. | duration of first visit (~1hour) | To correlate the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions. |
| Secondary | Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR). | after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour | To evaluate whether bee venom is associated with a higher frequency of side-effects. |
| Secondary | Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR). | after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour | To evaluate whether high specific immunoglobulin E (sIgE) levels are correlated to a higher frequency of side-effects. sIgE levels are expressed in kilo units/liter \[kU/L\]. |
| Secondary | Correlation of High Tryptase Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR). | after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour | To evaluate whether high tryptase levels are correlated to a higher frequency of side-effects |
| Secondary | Correlation of Quicker Up-dosing Protocols to a Higher Frequency of Side-effects (=Systemic Reaction, SR). | depends on the protocol used for venom immunotherapy, a maximum of about 6 months | To evaluate whether quicker up-dosing protocols are correlated to a higher frequency of side-effects. |
| Secondary | Efficacy of VIT | 1 year after reaching the maintenance dose; duration of Visit ~1hour | The outcome (systemic reaction to sting or not) of sting challenges and/or field stings will be recorded to identify patients who will not tolerate but react to future stings. These results will be compared between patients not taking antihypertensive (AHT) drugs and patients taking AHT drugs. |
| Secondary | Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Frequent Side Effects (=Systemic Reaction, SR) Under VIT. | duration of Visit ~1hour | To correlate the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent side effects (=systemic reaction, SR) under VIT.. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT) | after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour | 1342 patients underwent VIT and performed Visit 2. Of these 1342 patients, 93 experienced a systemic side effect during the updosing phase of VIT. Data were missing for 10 participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Severity of Sting Reactions | duration of first visit (~1hour) | 1425 patients were included in the study at Visit 1. Of these 1425 patients, 603 initially experienced a severe (=Grade 3 and 4 according to the classification of Ring and Messmer), systemic sting reaction. Data were missing for 2 participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions. | duration of first visit (~1hour) | Correlation cardiovascular disease with risk of more severe systemic sting reaction: 601 of 1425 patients (Visit 1) experienced a severe systemic sting reaction. Datasets missing:9 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR). | after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour | 1342 patients underwent VIT and performed Visit 2. Of these 1342 patients, 93 experienced a systemic side effect during the updosing phase of VIT. Data missing for 10 participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR). | after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour | 1342 patients underwent VIT and performed Visit 2. Of these 1342 patients, 93 experienced a systemic side effect during the updosing phase of VIT. sIgE levels were only available for 1009 patients, the other data (=333) are missing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Correlation of High Tryptase Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR). | after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour | 1342 patients underwent VIT and performed Visit 2. Of these 1342 patients, 93 experienced a systemic side effect during the updosing phase of VIT. Tryptase levels were only available for 1204 patients. Data missing for 138 participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Correlation of Quicker Up-dosing Protocols to a Higher Frequency of Side-effects (=Systemic Reaction, SR). | depends on the protocol used for venom immunotherapy, a maximum of about 6 months | 1342 patients underwent VIT and performed Visit 2. Of these 1342 patients, 93 experienced a systemic side effect during the updosing phase of VIT. Data concerning the updosing protocol used were available for 1321 patients; data missing for 21 participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy of VIT | 1 year after reaching the maintenance dose; duration of Visit ~1hour | Visit 3 was performed with 1186 patients one year after reaching the maintenance phase of VIT. Data missing for 4 participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Frequent Side Effects (=Systemic Reaction, SR) Under VIT. | duration of Visit ~1hour | Correlation cardiovascular disease with risk of more frequent side effects under VIT: 93 of 1342 patients (Visit 2) experienced a SR. Datasets missing:17 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT) | Patients Who Underwent VIT Updosing | number of patients with SR with AHT treatment | 19 | Participants | |
| Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT) | Patients Who Underwent VIT Updosing | number of patients with SR without AHT treatment | 74 | Participants | |
| Severity of Sting Reactions | Patients With a History of an Anaphylactic Sting Reaction | severe reactions in patients with AHT treatment | 171 | Participants | |
| Severity of Sting Reactions | Patients With a History of an Anaphylactic Sting Reaction | severe reactions in patients without AHT treatment | 432 | Participants | |
| Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions. | Patients With Anaphylactic Sting Reaction | severe sting reaction, cardiovascular disease | 258 | Participants | |
| Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions. | Patients With Anaphylactic Sting Reaction | severe sting reaction, no cardiovascular disease | 343 | Participants | |
| Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR). | Patients Who Underwent VIT Updosing | SR in patients treated with bee venom | 54 | Participants | |
| Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR). | Patients Who Underwent VIT Updosing | SR in patients treated with vespid venom | 39 | Participants | |
| Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR). | Patients Who Underwent VIT Updosing | SR, bee venom, IgE >0.35-3.5 kU/L | 17 | Participants | |
| Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR). | Patients Who Underwent VIT Updosing | SR, bee venom, IgE >3.5-17.5 kU/L | 17 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients With a History of an Anaphylactic Sting Reaction | 1,425 | |
| Overall Study | Number of Patients Who Performed VIT | Patients With a History of an Anaphylactic Sting Reaction | 1,342 | |
| Overall Study | COMPLETED | Patients With a History of an Anaphylactic Sting Reaction | 1,186 | |
| Overall Study | NOT COMPLETED | Patients With a History of an Anaphylactic Sting Reaction | 239 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients With a History of an Anaphylactic Sting Reaction | 0 | 0 |
| Total, other adverse events | Patients With a History of an Anaphylactic Sting Reaction | 0 | 0 |
| Total, serious adverse events | Patients With a History of an Anaphylactic Sting Reaction | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33605465 | 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/NCT04269629
GET https://conductscience.org/api/trials/v1/NCT04269629/results?page=2