The Effect of Proton Pump Inhibition on Palpitations

NCT03273634 | Completed Phase 4

• 1 other identifier: 123
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmia

Keywords

Palpitations

Outcome Measures

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)

  10 days after starting treatment

Study Arms (2)

Active treatment

EXPERIMENTAL

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

Drug: Lansoprazole Pill

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lansoprazole Pill DRUG

once daily at night time

Also known as: Lanzotec

Active treatment

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with palpitations and no clear cause who are above the age of 16 years and who consent to the study will be included
• 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
• 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.

You may not qualify if:

• Refusal to sign consent form
• Already taking PPI or H2 blocker
• Frequency of symptoms less than 2 times per week

Sponsors & Collaborators

• Jordan Collaborating Cardiology Group: lead
• University of Jordan: collaborator

Study Sites (1)

The University of Jordan

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Omar Ubaidat, MD

  Jordan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Similarly looking tablets and placebo with care providers not knowing which is which. Packets are marked "heads and tails" for randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 6, 2017
• Study Start: May 20, 2017
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)