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The Effect of Proton Pump Inhibition on Palpitations

Primary Purpose

Arrhythmia

Status
Completed
Phase
Phase 4
Locations
Jordan
Study Type
Interventional
Intervention
Lansoprazole Pill
Placebo
Sponsored by
Jordan Collaborating Cardiology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia focused on measuring Palpitations

Eligibility Criteria

16 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Persons with palpitations and no clear cause who are above the age of 16 years and who consent to the study will be included
  2. 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
  3. 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.

Exclusion Criteria:

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

Sites / Locations

  • The University of Jordan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active treatment

Placebo

Arm Description

The treatment will consist of lanzoprazole 30 mg once daily at night time

A Placebo pill to be given with similar looking to experimental drug but contains inactive ingredient

Outcomes

Primary Outcome Measures

Improvement in symptoms
Assessment of improvement in palpitations using a questionnaire. The improvement will be graded either non, mild, moderate, or great. The result will either negative (no or mild improvement), or positive (moderate or great improvement)

Secondary Outcome Measures

Full Information

First Posted
August 21, 2017
Last Updated
August 7, 2018
Sponsor
Jordan Collaborating Cardiology Group
Collaborators
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT03273634
Brief Title
The Effect of Proton Pump Inhibition on Palpitations
Official Title
The Effect of Proton Pump Inhibition on Palpitations With no Apparent Cause. A Double Blinded Randomized Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan Collaborating Cardiology Group
Collaborators
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Feeling of palpitations with no clear arrhythmia is frequently encountered in clinical practice. The majority of these patients have documented sinus rhythm even while having symptoms. Gastrointestinal association with such symptoms was first described by Ludwig von Roemheld (1871-1938).The investigators thought to investigate the effect of proton pump inhibition in patients with feeling of palpitations but no clear cause.
Detailed Description
One hundred and fifty patients with palpitations and no clear cause for their symptoms will be randomized to receive either proton pump inhibitor (PPI) (lanzoprazole 30 mg) or placebo for one month. At base line they will be investigated to rule out arrhythmia by documenting normal heart rate (less than 110 beat per minute) or ECG showing normal sinus rhythm or mild sinus tachycardia (Less than 110 per minute) during symptoms. Obvious causes such as anxiety due to a stressful event or organic causes such anemia or thyroid disorders should be also ruled out. Patient who agree to participate in the study will be asked to sign an informed consent. A baseline questionnaire with symptoms will be filled. They will then be randomized for treatment with either PPI or placebo once at night time. After 10 days of treatment they will be contacted and questioned regarding their symptoms. The two groups will be compared to see if there is any improvement of symptoms with treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Palpitations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Similarly looking tablets and placebo with care providers not knowing which is which. Packets are marked "heads and tails" for randomization
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active treatment
Arm Type
Experimental
Arm Description
The treatment will consist of lanzoprazole 30 mg once daily at night time
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A Placebo pill to be given with similar looking to experimental drug but contains inactive ingredient
Intervention Type
Drug
Intervention Name(s)
Lansoprazole Pill
Other Intervention Name(s)
Lanzotec
Intervention Description
once daily at night time
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Improvement in symptoms
Description
Assessment of improvement in palpitations using a questionnaire. The improvement will be graded either non, mild, moderate, or great. The result will either negative (no or mild improvement), or positive (moderate or great improvement)
Time Frame
10 days after starting treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Refusal to sign consent form Already taking PPI or H2 blocker Frequency of symptoms less than 2 times per week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Ubaidat, MD
Organizational Affiliation
Jordan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Jordan
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Proton Pump Inhibition on Palpitations

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