Complete Heart BlockPhase 4NCT05666219
Reversal of Complete Heart Block With Aminophylline in Inferior Wall Myocardial Infarction Patients
A Phase 4 study testing Aminophylline Injection in people with Complete Heart Block and Inferior Wall Myocardial Infarction, run by National Institute of Cardiovascular Diseases, Pakistan.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complete Heart Block, Inferior Wall Myocardial Infarction
- What is being tested?
- Aminophylline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2022to 17 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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)
Read the 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.
- Being tested
- Aminophylline Injection
- Medical subject headings
- Inferior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminophylline InjectionDrug
Also called Theophylline
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients receiving Injection Aminophylline Receives: Drug: Aminophylline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of complete heart block
Conversion to sinus rhythm with 1:1 conduction
Measured: Within 1 hour of 2nd dose
Secondary outcomes (2)
Improved conduction
Combined end point of 1:1 conduction and improved conduction to second degree AV block
Measured: 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
Measured: Within 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start19 Dec 2022
- Primary completion18 Dec 2023
- Study completion17 Jan 2025 (estimated)
Why it stopped: we could not find patients fulfilling all of our inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Heart BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An Open Label Non-randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azam Shafquat, MD, Study chair, National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666219
- Sponsor's protocol ID
- ERC-32/2022
- Status last verified
- May 2025
- First submitted
- 13 Dec 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data sharing plan in placed
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05666219
- Acronym / sponsor ID
- ERC-32/2022
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: we could not find patients fulfilling all of our inclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 17 Jan 2025 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An Open Label Non-randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Aminophylline InjectionPatients receiving Injection Aminophylline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminophylline InjectionAlso: TheophyllineInjection Aminophylline IV 240 mg will be given over 10 minutes. After 1 hour, Aminophylline 240 mg second dose will be given over 10 minutes. | Drug | Treatment group |
Primary outcome
Reversal of complete heart block
Time frame: Within 1 hour of 2nd dose
Conversion to sinus rhythm with 1:1 conduction
2 secondary outcomes
Improved conduction
Time frame: Within 1 hour of 2nd dose
Major adverse cardiac events (MACE)
Time frame: Within 12 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No. No individual participant data sharing plan in placed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azam Shafquat, MD study chair
National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aminophylline Injection in people with Complete Heart Block and Inferior Wall Myocardial Infarction, run by National Institute of Cardiovascular Diseases, Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal of complete heart block (time frame: Within 1 hour of 2nd dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.