NCT06312891

Brief Summary

To study the value of heart rate lowering therapy "pharmacological rest" on the short term in cases of myocarditis without LV dysfunction.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 9, 2024

Last Update Submit

March 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Conventional anti-inflammatory treatment (control group).

Conventional ttt PLUS Carvedilol.

Conventional ttt PLUS Ivabradine.

Drug: Ivabradine

Interventions

heart rate lowering therapy

Conventional ttt PLUS Ivabradine.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who meet the study's inclusion \& exclusion criteria

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Myocarditis

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at student hospital , assiut university

Study Record Dates

First Submitted

March 9, 2024

First Posted

March 15, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations