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

May 20, 2025 updated by: National Institute of Cardiovascular Diseases, Pakistan

Assessing the Impact of Aminophylline in the Reversal of Complete Heart Block Secondary to Inferior Wall MI in Atropine Resistant Patients: An Open Label Non-randomized Clinical Trial

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)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Administration of Aminophylline can result in reversal of complete heart block in a significant number of atropine resistant patients with inferior wall MI. Hence, in this study our primary aim is to evaluate the rate of reversal of complete heart block with aminophylline in atropine resistant patients with inferior wall MI.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Patients receiving Injection Aminophylline
Drug: Aminophylline Injection
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.
Other Names:
  • Theophylline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reversal of complete heart block
Time Frame: Within 1 hour of 2nd dose
Conversion to sinus rhythm with 1:1 conduction
Within 1 hour of 2nd dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved conduction
Time Frame: Within 1 hour of 2nd dose
Combined end point of 1:1 conduction and improved conduction to second degree AV block
Within 1 hour of 2nd dose
Major adverse cardiac events (MACE)
Time Frame: Within 12 hours
Ventricular arrhythmias ( VT more than 3 beats), decrease in ventricular escape rate requiring increasing pacing rate, cardiac arrest or death
Within 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiovascular Diseases, Pakistan

Investigators

  • Study Chair: Azam Shafquat, MD, National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Actual)

December 18, 2023

Study Completion (Estimated)

January 17, 2025

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 17, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC-32/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data sharing plan in placed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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