Reversal of Complete Heart Block With Aminophylline in Inferior Wall Myocardial Infarction Patients

NCT05666219 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: ERC-32/2022
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigator will evaluate the rate of reversal of complete heart block with aminophylline in atropine resistant patients with inferior wall myocardial infarction (MI)

Conditions

Complete Heart Block; Inferior Wall Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Reversal of complete heart block

  Conversion to sinus rhythm with 1:1 conduction

  Within 1 hour of 2nd dose

Secondary Outcomes (2)

• Improved conduction

  Within 1 hour of 2nd dose

• Major adverse cardiac events (MACE)

  Within 12 hours

Study Arms (1)

Treatment group

EXPERIMENTAL

Patients receiving Injection Aminophylline

Drug: Aminophylline Injection

Interventions

Aminophylline Injection DRUG

Injection Aminophylline IV 240 mg will be given over 10 minutes. After 1 hour, Aminophylline 240 mg second dose will be given over 10 minutes.

Also known as: Theophylline

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients admitted with recent acute inferior wall myocardial infarction (MI)
• Hemodynamically stable blood pressure
• Complete heart block with Narrow QRS \< 120 ms and ventricular rate \>40/min persisting for at least 6 hours, resistant to atropine
• Temporary pacemaker (TPM) already placed
• Patient asymptomatic with a mean arterial pressure of greater than 65 mmHg with TPM rate placed at 40/min

You may not qualify if:

• Patients with cardiogenic shock
• Patients with preexisting permanent pacemaker and Implantable Cardioverter Defibrillator (ICD).
• Patients with a prior history of AV block
• Drugs with dromotropic effects (beta blocker, calcium channel blocker, inotropes)
• Known liver disease (cirrhosis, hepatitis)
• Hypothyroidism
• Unable to consent

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

MeSH Terms

Conditions

Inferior Wall Myocardial Infarction

Interventions

Aminophylline; Theophylline

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Alkaloids

Study Officials

• Azam Shafquat, MD

  National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An Open Label Non-randomized Clinical Trial

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 27, 2022
• Study Start: December 19, 2022
• Primary Completion: December 18, 2023
• Study Completion: January 17, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share