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

Complete Heart Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666219
• Other study ID #: ERC-32/2022
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 19, 2022
• Est. completion date: June 18, 2023

Study information

• Verified date: December 2022
• Source: National Institute of Cardiovascular Diseases, Karachi
• Contact: Deebaj Nadeem, FCPS
• Phone: +923360833853
• Email: deeb2512[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 73
• Est. completion date: June 18, 2023
• Est. primary completion date: June 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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 prior history of AV block

• Drugs with dromo-tropic effects (beta blocker, calcium channel blocker, inotropes)

• Known liver disease (cirrhosis, hepatitis)

• Hypothyroidism

• Unable to consent

Related Conditions & MeSH terms

• Complete Heart Block
• Heart Block
• Infarction
• Inferior Wall Myocardial Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiovascular Diseases, Karachi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal of complete heart block	Conversion to sinus rhythm with 1:1 conduction	Within 1 hour of 2nd dose
Secondary	Improved conduction	Combined end point of 1:1 conduction and improved conduction to second degree AV block	Within 1 hour of 2nd dose
Secondary	Major adverse cardiac events (MACE)	Ventricular arrhythmias ( VT more than 3 beats), decrease in ventricular escape rate requiring increasing pacing rate, cardiac arrest or death	Within 12 hours