Clinical trial NCT03273634: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arrhythmia
Keywords: Palpitations
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
Collaborators: name: University of Jordan
First posted: 2017-09-06
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Improvement in symptoms
timeFrame: 10 days after starting treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: The University of Jordan
Study officials:
affiliation: Jordan University Hospital
name: Omar Ubaidat, MD
role: STUDY_CHAIR
References: