MyocarditisNCT06312891
Value of Heart Rate Lowering Therapy in Acute Myocarditis
An observational study of Myocarditis, run by Assiut University at 1 site in Egypt.
Trial summary
To study the value of heart rate lowering therapy "pharmacological rest" on the short term in cases of myocarditis without LV dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocarditis
- What is being tested?
- Ivabradine
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet the study's inclusion \& exclusion criteria
Who may be able to join
- Adults: ≥18 years of age.
- Presentation: at least one of the following:
- Myopericarditis/ACS-like
- MINOCA
- Arrhythmias: brady or tachyarrhythmias.
- Unexplained compensated acute cardiomyopathy (excluded ischemic, valvular, hypertensive, metabolic, and toxic causes of cardiomyopathy as indicated clinically).
- TTE: LVEF>40%
- CMR-confirmed myo(peri)carditis (Lake Louise criteria)
Who cannot join
- • Rheumatic carditis.
- Connective tissue diseases (-ve ANA).
- Cancer chemotherapy.
- Toxicity from immunotherapy.
- Vaccine-related myocarditis.
- Presence of coronary artery disease.
Show all 11Show fewer
- Peripartum (occurring during the last month of pregnancy or within 5 months after delivery)
- ECG: atrial fibrillation/flutter.
- Resuscitated sudden death.
- Early/initial phase of decompensated heart failure.
- Tamponade complicating pericarditis unless successfully managed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Heart Hospital
Asyut
sara mahmoud, master, 01016862195, saramahmoud199783@gmail.com
About this study
To study the value of heart rate lowering therapy "pharmacological rest" on the short term in cases of myocarditis without LV dysfunction.
- Conditions
- Myocarditis
- Being tested
- Ivabradine
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
heart rate lowering therapy
| Study group | Role | What they receive |
|---|---|---|
| Conventional anti-inflammatory treatment (control group). | Not described | |
| Conventional ttt PLUS Carvedilol. | Not described | |
| Conventional ttt PLUS Ivabradine. | Not described Receives: Drug: Ivabradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of Heart Rate Lowering Therapy in Acute Myocarditis
To study the value of heart rate lowering therapy "pharmacological rest" on the short term in cases of myocarditis without LV dysfunction.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mahmoud Moustafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312891
- Sponsor's protocol ID
- VOHRLTIAM
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Heart Rate Lowering Therapy in Acute Myocarditis
- ClinicalTrials.gov ID
- NCT06312891
- Acronym / sponsor ID
- VOHRLTIAM
- Conditions
- Myocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the value of heart rate lowering therapy "pharmacological rest" on the short term in cases of myocarditis without LV dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional anti-inflammatory treatment (control group). | – | – |
| Conventional ttt PLUS Carvedilol. | – | – |
| Conventional ttt PLUS Ivabradine. | – | Drug: Ivabradine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the study's inclusion \& exclusion criteria
Key inclusion criteria (8 listed)
- Adults: ≥18 years of age.
- Presentation: at least one of the following:
- TTE: LVEF>40%
- CMR-confirmed myo(peri)carditis (Lake Louise criteria)
Key exclusion criteria (11 listed)
- • Rheumatic carditis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivabradineheart rate lowering therapy | Drug | Conventional ttt PLUS Ivabradine. |
Primary outcome
Value of Heart Rate Lowering Therapy in Acute Myocarditis
Time frame: baseline
To study the value of heart rate lowering therapy "pharmacological rest" on the short term in cases of myocarditis without LV dysfunction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara mahmoud (01016862195, saramahmoud199783@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of Heart Rate Lowering Therapy in Acute Myocarditis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.