Effect of Proton Pump Inhibitors on Palpitations

NCT02826408 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Palpitation is a common complaint. Patients frequently feel this symptom despite having normal rhythm during symptoms. I have seen many patients who improve significantly on treatment with proton pump inhibitors (PPI). It may be that gastritis provokes a feeling of discomfort that subsequently starts the feeling of palpitation. On searching literature I found no study that investigated the effect of PPI's on palpitations. Therefore I propose a study where the investigators randomize people with palpitations with normal heart rate (no arrhythmia) and no apparent cause such as anxiety or clear illness to receive either PPI or placebo. The result will help to investigate if the improvement is true and if the results are positive this can provide a simple treatment for a common problem.

Conditions

Signs and Symptoms

Outcome Measures

Primary Outcomes (1)

• Improvement in Palpitations

  Improvement will be assessed by questionaire

  2 weeks

Study Arms (2)

Active group

ACTIVE COMPARATOR

Will receive Rabeprazole sodium (Proton pump inhibitor 20 mg once daily)

Drug: Rabeprazole sodium

Placebo group

PLACEBO COMPARATOR

Will receive Folic acid 5 mg once daily

Drug: Pacebo

Interventions

Rabeprazole sodium DRUG

WIll study effect of the medication on palpittions

Also known as: Active treatment

Active group

Pacebo DRUG

Placebo comparison to active treatment

Placebo group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with palpitations and no clear cause who are above the age of 16 years and who consent to the study will be included
• Clear causes that should be excluded are true arrhythmia such SVT or VT or frequent premature atrial or ventricular contractions or any organic cause such as thyroid disorder, anemia (hg less than 11 g/dl) and obvious anxiety disorder
• Arrhythmia can be excluded by an ECG showing sinus rhythm or sinus tachycardia during episodes or measurement of heart rate by a reliable method during symptoms showing regular heart rate less than 120 beats per minute.
• Patient will be randomized to either PPI or placebo to be taken one table at night time
• Patients will be provided with 2 weeks supply but will be evaluated at 10 days to see if symptoms improved
• The two groups will be compared using statistical methods to see if there is difference in improvement.

You may not qualify if:

• Refusal to participate or sign consent form
• Frequency of symptoms less than 2 times per week
• Already taking PPI or H2 blocker

Sponsors & Collaborators

• Jordan Collaborating Cardiology Group: lead

Study Sites (1)

Istishari Hospital

Amman, 11184, Jordan

Location

Related Links

• abstract of study

MeSH Terms

Conditions

Signs and Symptoms

Interventions

Rabeprazole; PACEBO protocol

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Munir Zaqqa, MD

  Organizer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 11, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

JO (1)