Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 3:58 AM
Study NCT ID:
NCT03273634
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2017-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Proton Pump Inhibition on Palpitations
Sponsor:
Jordan Collaborating Cardiology Group
Organization:
Study Overview
Official Title:
The Effect of Proton Pump Inhibition on Palpitations With no Apparent Cause. A Double Blinded Randomized Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: