Reversal of Complete Heart Block With Aminophylline in In... | NCT05666219

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

NCT05666219

Sponsor

National Institute of Cardiovascular Diseases, Pakistan

Status

Withdrawn

Last Update Posted

May 25, 2025Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Complete Heart Block
Inferior Wall Myocardial Infarction

Interventions

Aminophylline Injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

we could not find patients fulfilling all of our inclusion criteria

Expanded Access Info

Start Date

Dec 19, 2022Actual

Primary Completion Date

Dec 18, 2023Actual

Completion Date

Jan 17, 2025Estimated

First Submitted Date

Dec 13, 2022

First Submission Date that Met QC Criteria

Dec 17, 2022

First Posted Date

Dec 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2025

Last Update Posted Date

May 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	Patients receiving Injection Aminophylline	Drug: Aminophylline Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	Treatment group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Improved conduction	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)	Ventricular arrhythmias ( VT more than 3 beats), decrease in ventricular escape rate requiring increasing pacing rate, cardiac arrest or death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Azam Shafquat, MD	National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

No individual participant data sharing plan in placed

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056989	Inferior Wall Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000628	Aminophylline
D013806	Theophylline

Ancestor Terms

ID	Term
D005029	Ethylenediamines
D003959	Diamines
D011073	Polyamines
D000588	Amines
D009930

Browse Leaves

Not provided

Browse Branches

Not provided