The Effect of Proton Pump Inhibition on Palpitations

Arrhythmia Clinical Trial

Official title:

The Effect of Proton Pump Inhibition on Palpitations With no Apparent Cause. A Double Blinded Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273634
• Other study ID #: 123
• Status: Completed
• Phase: Phase 4
• Start date: May 20, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: August 2018
• Source: Jordan Collaborating Cardiology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Drug:
• Lansoprazole Pill
once daily at night time
• Placebo
Placebo

Locations

Country	Name	City	State
Jordan	The University of Jordan	Amman

Sponsors (2)

Lead Sponsor	Collaborator
Jordan Collaborating Cardiology Group	University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	10 days after starting treatment