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
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.
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.
Exclusion Criteria:
The treatment will consist of lanzoprazole 30 mg once daily at night time
Drug: Lansoprazole Pill
A Placebo pill to be given with similar looking to experimental drug but contains inactive ingredient
Drug: Placebo
once daily at night time
Also known as: Lanzotec
Placebo
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
Plan to share: No
No publications or documents are linked to this record.
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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Jordan Collaborating Cardiology Group