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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05666219
Enrollment
0
Registered
2022-12-27
Start date
2022-12-19
Completion date
2025-01-17
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete Heart Block, Inferior Wall Myocardial Infarction

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)

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.

Interventions

DRUGAminophylline 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.

Sponsors

National Institute of Cardiovascular Diseases, Pakistan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

An Open Label Non-randomized Clinical Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reversal of complete heart blockWithin 1 hour of 2nd doseConversion to sinus rhythm with 1:1 conduction

Secondary

MeasureTime frameDescription
Improved conductionWithin 1 hour of 2nd doseCombined end point of 1:1 conduction and improved conduction to second degree AV block
Major adverse cardiac events (MACE)Within 12 hoursVentricular arrhythmias ( VT more than 3 beats), decrease in ventricular escape rate requiring increasing pacing rate, cardiac arrest or death

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026