Value of Heart Rate Lowering Therapy in Acute Myocarditis | NCT06312891

Studies
Value of Heart Rate Lowering Therapy in Acute Myocarditis

NCT06312891

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 15, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Myocarditis

Interventions

Ivabradine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

Jun 1, 2025Estimated

First Submitted Date

Mar 9, 2024

First Submission Date that Met QC Criteria

Mar 9, 2024

First Posted Date

Mar 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2024

Last Update Posted Date

Mar 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional anti-inflammatory treatment (control group).
Conventional ttt PLUS Carvedilol.
Conventional ttt PLUS Ivabradine.			Drug: Ivabradine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ivabradine	Drug	heart rate lowering therapy	Conventional ttt PLUS Ivabradine.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

• Rheumatic carditis.
- Connective tissue diseases (-ve ANA).
- Cancer chemotherapy.
- Toxicity from immunotherapy.
- Vaccine-related myocarditis.
- Presence of coronary artery disease.
- 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who meet the study's inclusion & exclusion criteria

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
sara mahmoud	Contact	01016862195		saramahmoud199783@gmail.com

Facility	Status	City	State	ZIP	Country	Contacts
Heart Hospital	Recruiting	Asyut			Egypt

ID	Term
D009205	Myocarditis

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000077550	Ivabradine

Ancestor Terms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided