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COMPARISON OF EFFICACY OF ORAL VERSUS INTRAVENOUS DILTIAZEM(DRUG USED TO CONTROL HEART RATE) IN PATIENTS WITH RAPID IRREGULAR HEART RATE

COMPARISON OF EFFICACY OF INTRAVENOUS INFUSION VERSUS ORAL DILTIAZEM IN PATIENTS WITH ATRIAL FIBRILLATION AND RAPID VENTRICULAR RATE FOR RATE CONTROL:AN EXPLORATORY RANDOMISED CONTROL TRIAL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047351
Enrollment
60
Registered
2022-11-16
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: I480- Paroxysmal atrial fibrillation

Interventions

Intervention1: Diltiazem: Diltiazem immediate release tablet 60mg stat dose Control Intervention1: Diltiazem: Diltiazem intravenous infusion 5mg/Hr titrated upto 1.25mg/Hr every 15-60 mins to a maxi

Sponsors

AIIMS RISHIKESH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age >18yrs 2.Patients presenting to ED of AIIMS Rishikesh with Atrial Fibrillation (AF)with rapid ventricular rate (Ventricular rate >110/min) and having received initial diltiazem iv bolus (weight based).

Exclusion criteria

Exclusion criteria: 1.Hemodynamically unstable patients a) Systolic BP b) Acutely altered mental status c) Signs of shock d) Ischemic chest discomfort e) Acute heart failure 2.Any patient requiring electrical cardioversion. 3.Patients diagnosed with acute myocardial infarction. 4.Patients already received another antiarrhythmic agent within 24 hours before inclusion in study. 5.Patients in whom oral drug cannot be administered. 6.Hepatic dysfunction a) Decompensated chronic liver failure b) Severe acute hepatitis 7.Patients diagnosed with pre-excitation syndromes. 8.Patients not consenting to be part of the study.

Design outcomes

Primary

MeasureTime frame
1. Achievement of rate control i.e ventricular rate 110/min at 4 hours after enrolment in the study.Timepoint: 4 hour

Secondary

MeasureTime frame
1. Need for additional intravenous (IV) boluses of diltiazem. 2. Need for switching from oral to iv infusion. 3. Need for another antiarrhythmic agent for rate control. 4. Need for vasopressor support. 5. Need for DC Cardioversion 6. Length of stay in the emergency department. 7. Length of in hospital stay. 8. Occurrence of any adverse effects. 9. Conversion to sinus rhythm. Timepoint: 4 hour

Countries

India

Contacts

Public ContactJEWEL RANI JOSE

AIIMS RISHIKESH

bharatbbhardwaj@gmail.com9889822922

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026