Signs and SymptomsNCT02826408
Effect of Proton Pump Inhibitors on Palpitations
A study testing Rabeprazole sodium and Pacebo in people with Signs and Symptoms, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
Trial summary
Palpitation is a common complaint. Patients frequently feel this symptom despite having normal rhythm during symptoms. I have seen many patients who improve significantly on treatment with proton pump inhibitors (PPI). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Signs and Symptoms
- What is being tested?
- Rabeprazole sodium and Pacebo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJordan
- Study dates
- Oct 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Patient will be randomized to either PPI or placebo to be taken one table at night time
- Patients will be provided with 2 weeks supply but will be evaluated at 10 days to see if symptoms improved
- The two groups will be compared using statistical methods to see if there is difference in improvement.
Who cannot join
- Refusal to participate or sign consent form
- Frequency of symptoms less than 2 times per week
- Already taking PPI or H2 blocker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo Controlled Trial on the Effect of Proton Pump Inhibitors on Palpitations With no Apparent Cause to Explain Such a Symptom
Palpitation is a common complaint. Patients frequently feel this symptom despite having normal rhythm during symptoms. I have seen many patients who improve significantly on treatment with proton pump inhibitors (PPI). It may be that gastritis provokes a feeling of discomfort that subsequently starts the feeling of palpitation. On searching literature I found no study that investigated the effect of PPI's on palpitations. Therefore I propose a study where the investigators randomize people with palpitations with normal heart rate (no arrhythmia) and no apparent cause such as anxiety or clear illness to receive either PPI or placebo. The result will help to investigate if the improvement is true and if the results are positive this can provide a simple treatment for a common problem.
Read the detailed description
Methods Two hundred patients with palpitations and no clear cause for their symptoms will be randomized to receive either PPI 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.
Studying group The study will be under the umbrella of the JCC group. Primary investigators are Dr Munir Zaqqa and Dr Ismail Hamam
Support required Pharmaceutical company will be contacted to provide 120 packets with 30 tabs of PPI and if possible packets with similar matching placebo to support the study
Study criteria inclusion
- 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.
- Patient will be randomized to either PPI or placebo to be taken one table at night time
- Patients will be provided with 2 weeks supply but will be evaluated at 10 days to see if symptoms improved
- The two groups will be compared using statistical methods to see if there is difference in improvement.
Expected harm:
PPI's are generally safe medications. Side effects are rare and generally mild. They include nausea, stomach pain, diarrhea, constipation or headache.
Very rarely allergic reaction can occur with hives, difficulty in breathing and swelling of the face and lips.
Benefit to the patient:
Patients randomized to either group may experience benefit due to the medication or even placebo use. There is no financial benefit of participating in the study. The result of the study will be used to help patient in the future with similar symptoms
- Conditions
- Signs and Symptoms
- Being tested
- Rabeprazole sodium, Pacebo
- Medical subject headings
- Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole sodiumDrug
Also called Active treatment
WIll study effect of the medication on palpittions
PaceboDrug
Placebo comparison to active treatment
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Will receive Rabeprazole sodium (Proton pump inhibitor 20 mg once daily) Receives: Drug: Rabeprazole sodium |
| Placebo group | Placebo comparator | Will receive Folic acid 5 mg once daily Receives: Drug: Pacebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Palpitations
Improvement will be assessed by questionaire
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Signs and SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Munir Zaqqa, MD, Principal investigator, Organizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826408
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2018
- First submitted
- 5 Jul 2016
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo Controlled Trial on the Effect of Proton Pump Inhibitors on Palpitations With no Apparent Cause to Explain Such a Symptom
- ClinicalTrials.gov ID
- NCT02826408
- Acronym / sponsor ID
- 1
- Conditions
- Signs and Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Palpitation is a common complaint. Patients frequently feel this symptom despite having normal rhythm during symptoms. I have seen many patients who improve significantly on treatment with proton pump inhibitors (PPI). It may be that gastritis provokes a feeling of discomfort that subsequently starts the feeling of palpitation. On searching literature I found no study that investigated the effect of PPI's on palpitations. Therefore I propose a study where the investigators randomize people with palpitations with normal heart rate (no arrhythmia) and no apparent cause such as anxiety or clear illness to receive either PPI or placebo. The result will help to investigate if the improvement is true and if the results are positive this can provide a simple treatment for a common problem.
Detailed description
Methods Two hundred patients with palpitations and no clear cause for their symptoms will be randomized to receive either PPI 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.
Studying group The study will be under the umbrella of the JCC group. Primary investigators are Dr Munir Zaqqa and Dr Ismail Hamam
Support required Pharmaceutical company will be contacted to provide 120 packets with 30 tabs of PPI and if possible packets with similar matching placebo to support the study
Study criteria inclusion
- 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.
- Patient will be randomized to either PPI or placebo to be taken one table at night time
- Patients will be provided with 2 weeks supply but will be evaluated at 10 days to see if symptoms improved
- The two groups will be compared using statistical methods to see if there is difference in improvement.
Expected harm:
PPI's are generally safe medications. Side effects are rare and generally mild. They include nausea, stomach pain, diarrhea, constipation or headache.
Very rarely allergic reaction can occur with hives, difficulty in breathing and swelling of the face and lips.
Benefit to the patient:
Patients randomized to either group may experience benefit due to the medication or even placebo use. There is no financial benefit of participating in the study. The result of the study will be used to help patient in the future with similar symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Drug: Rabeprazole sodiumWill receive Rabeprazole sodium (Proton pump inhibitor 20 mg once daily) |
| Placebo group | Placebo comparator | Drug: PaceboWill receive Folic acid 5 mg once daily |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Patient will be randomized to either PPI or placebo to be taken one table at night time
- Patients will be provided with 2 weeks supply but will be evaluated at 10 days to see if symptoms improved
Key exclusion criteria (3 listed)
- Refusal to participate or sign consent form
- Frequency of symptoms less than 2 times per week
- Already taking PPI or H2 blocker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rabeprazole sodiumAlso: Active treatmentWIll study effect of the medication on palpittions | Drug | Active group |
| PaceboPlacebo comparison to active treatment | Drug | Placebo group |
Primary outcome
Improvement in Palpitations
Time frame: 2 weeks
Improvement will be assessed by questionaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- abstract of studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Munir Zaqqa, MD principal investigator
Organizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rabeprazole sodium and Pacebo in people with Signs and Symptoms, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Palpitations (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.