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CompletedNCT03273634Updated Aug 8, 2018

The Effect of Proton Pump Inhibition on Palpitations

A Phase 4 interventional study of Lansoprazole Pill and Placebo in Arrhythmia, sponsored by Jordan Collaborating Cardiology Group. Completed at 1 site in Jordan. Open to participants aged 16 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-08-08.

Sponsored by Jordan Collaborating Cardiology Group · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
16 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Arrhythmia

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Keywords

  • Palpitations
03

Who can participate

Ages eligible
16 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Active treatment

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

    Drug: Lansoprazole Pill

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugLansoprazole Pill

    once daily at night time

    Also known as: Lanzotec

  • DrugPlacebo

    Placebo

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 10 days after starting treatment

06

Study locations

1 site
  • The University of Jordan
    Amman, 11942, Jordan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03273634
Lead sponsor
Jordan Collaborating Cardiology Group
Collaborators
University of Jordan
Responsible party
Sponsor
First posted
Sep 6, 2017
Start date
May 20, 2017
Primary completion
May 1, 2018
Completion
Jun 1, 2018
Last update
Aug 8, 2018

Study contacts

Omar Ubaidat, MD
study chair · Jordan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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