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The Effect of Proton Pump Inhibition on Palpitations

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ClinicalTrials.gov Identifier: NCT03273634
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
University of Jordan
Information provided by (Responsible Party):
Jordan Collaborating Cardiology Group

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.

Condition or disease Intervention/treatment Phase
Arrhythmia Drug: Lansoprazole Pill Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Similarly looking tablets and placebo with care providers not knowing which is which. Packets are marked "heads and tails" for randomization
Primary Purpose: Treatment
Official Title: The Effect of Proton Pump Inhibition on Palpitations With no Apparent Cause. A Double Blinded Randomized Placebo Controlled Trial
Actual Study Start Date : May 20, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arm Intervention/treatment
Experimental: Active treatment
The treatment will consist of lanzoprazole 30 mg once daily at night time
Drug: Lansoprazole Pill
once daily at night time
Other Name: Lanzotec

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




Primary Outcome Measures :
  1. Improvement in symptoms [ Time Frame: 10 days after starting treatment ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273634


Locations
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Jordan
The University of Jordan
Amman, Jordan, 11942
Sponsors and Collaborators
Jordan Collaborating Cardiology Group
University of Jordan
Investigators
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Study Chair: Omar Ubaidat, MD Jordan University Hospital
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Responsible Party: Jordan Collaborating Cardiology Group
ClinicalTrials.gov Identifier: NCT03273634    
Other Study ID Numbers: 123
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordan Collaborating Cardiology Group:
Palpitations
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action