DysphagiaNCT02428959
Diagnostic Utility of Amyl Nitrite in Patients With Suspected Achalasia Undergoing High Resolution Esophageal Manometry (HREM)
A study testing Amyl Nitrite in people with Dysphagia and Achalasia, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to see if a study drug called amyl nitrite can be helpful with diagnosing different disorders affecting the lower esophageal sphincter in patients with dysphagia (difficulty swallowing foods) undergoing high resolution esophageal manometry (HRM). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Amyl Nitrite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80 years old
- symptoms of dysphagia or a known history of achalasia
Who cannot join
- Patients with comorbidity and contraindications to use of amyl nitrite inhalation: Glaucoma, Recent head trauma or cerebral hemorrhage, Hypotension, Concurrent use of nitrite, Pregnancy, Aortic stenosis, Patients with increased intracranial pressure, Caution in patients with coronary artery disease, Pulmonary hypertension
- Non-English speakers
- Patients <18 years old
- Those who lack capacity to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study to Assess the Diagnostic Utility of Amyl Nitrite in Patients With Suspected Achalasia Undergoing High Resolution Esophageal Manometry (HREM)
This research is being done to see if a study drug called amyl nitrite can be helpful with diagnosing different disorders affecting the lower esophageal sphincter in patients with dysphagia (difficulty swallowing foods) undergoing high resolution esophageal manometry (HRM).
Dysphagia may be one of the symptoms of a condition known as idiopathic achalasia. Achalasia is a disorder of the esophagus, the tube that carries food from the mouth to the stomach. This affects the ability of the esophagus to move food toward the stomach. Pseudoachalasia is a secondary form of achalasia, which has very similar symptoms but is caused by different reasons. Because the treatments for achalasia and pseudoachalasia are different, it is important to correctly diagnose each condition. At this time, there is no way to distinguish the two with the current tests used at Johns Hopkins.
Read more
Amyl nitrite relaxes vascular smooth muscle and has been studied previously as a potential means to separate achalasia from pseudoachalasia. Amyl nitrite is approved by the Food and Drug Administration (FDA) for the treatment of cardiac angina. It is not approved for use in motility testing and its use in this study is considered investigational. Investigators hope that the results from the proposed study could have significant clinical implications for patient management by helping doctors distinguish between achalasia and pseudoachalasia and allow them to choose appropriate treatment.
Patients with dysphagia (difficulty swallowing foods) undergoing routinely scheduled high resolution esophageal manometry (HRM) may join this study.
Read the detailed description
A single center, prospective study at a tertiary-care referral center (JHH). All patients will be provided with informed consent to undergo HRM with provocation as part of routine care to evaluate dysphagia symptoms or evaluation of known achalasia. All procedures will be performed as part of routine care and therefore no procedures will be performed for the purposes of research specifically.
Primary Objective: To determine the diagnostic advantage of the addition of the provocative amyl nitrite test in patients with dysphagia undergoing high resolution esophageal manometry (HRM)
Secondary Objective:
- Measure change of LES pressure after amyl nitrite inhalation in patients with dysphagia undergoing high resolution esophageal manometry (HRM)
- To assess the ability of amyl nitrite inhalation to differentiate achalasia from pseudoachalasia
- To assess the ability of amyl nitrite inhalation to differentiate partial fundoplication-related dysphagia versus that due to recrudescence of achalasia in patients who have undergone a prior myotomy.
- To assess the ability of amyl nitrite inhalation to differentiate post-fundoplication dysphagia from a newly diagnosed motility disorder in patients who have undergone a fundoplication for gastroesophageal reflux disease.
- Being tested
- Amyl Nitrite
- Keywords
- Amyl Nitrite, High Resolution Manometry
- Medical subject headings
- Deglutition Disorders, Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amyl NitriteDrug
Amyl nitrite is the chemical compound with the formula C5H11ONO. It relaxes vascular smooth muscle; decreases venous ratios and arterial blood pressure; reduces left ventricular work; decreases myocardial oxygen consumption. The method of administration is via inhalation with onset of action within of 30 seconds and ends 2-3mins. In a study by Dodds et al., amyl nitrite is used as part of radiologic esophagram test in order to distinguish patients with pseudoachalasia from those with idiopathic achalasia since amyl nitrite has transient effect on the lower esophageal sphincter (LES). The study revealed that the LES pressure in achalasia patient decreases substantially in response to amyl nitrite with the measurable increase in LES diameter of 3 mm to an average of 4.6m. In contrast, amyl nitrite does not relax the LES segment in pseudoachalasia and has no change in LES diameter. Thus, the investigators anticipate amyl nitrite inhalation will be beneficial at the LES during HREM.
| Study group | Role | What they receive |
|---|---|---|
| Amyl Nitrite | Experimental | Amyl nitrite is the chemical compound with the formula C5H11ONO. It relaxes vascular smooth muscle.The method of administration is via inhalation with onset of action within of 30 seconds and ends 2-3mins. In a study by Dodds et al., amyl nitrite is used as part of radiologic esophagram test in order to distinguish patients with pseudoachalasia from those with idiopathic achalasia since amyl nitrite has transient effect on the lower esophageal sphincter (LES). The study revealed that the LES pressure in achalasia patient decreases substantially in response to amyl nitrite with the measurable increase in LES diameter of 3 mm to an average of 4.6m. In contrast, amyl nitrite does not relax the LES segment in pseudoachalasia and has no change in LES diameter. Thus, the investigators anticipate amyl nitrite inhalation will be beneficial at the LES during HREM. Receives: Drug: Amyl Nitrite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure LES pressure after amyl nitrite inhalation in patients with dysphagia undergoing high resolution esophageal manometry (HRM)
Measured: 3 months
Secondary outcomes (2)
Measure Blood Pressure and Heart Rate at baseline and after administration of amyl nitrite
Measured: 1 month
Number of Participants with Adverse Events with amyl nitrite inhalation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Stein, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428959
- Sponsor's protocol ID
- IRB00029912
- Status last verified
- Sep 2019
- First submitted
- 20 Apr 2015
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Assess the Diagnostic Utility of Amyl Nitrite in Patients With Suspected Achalasia Undergoing High Resolution Esophageal Manometry (HREM)
- ClinicalTrials.gov ID
- NCT02428959
- Acronym / sponsor ID
- IRB00029912
- Keywords
- Amyl Nitrite, High Resolution Manometry
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 29 Apr 2015 (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.
This research is being done to see if a study drug called amyl nitrite can be helpful with diagnosing different disorders affecting the lower esophageal sphincter in patients with dysphagia (difficulty swallowing foods) undergoing high resolution esophageal manometry (HRM).
Dysphagia may be one of the symptoms of a condition known as idiopathic achalasia. Achalasia is a disorder of the esophagus, the tube that carries food from the mouth to the stomach. This affects the ability of the esophagus to move food toward the stomach. Pseudoachalasia is a secondary form of achalasia, which has very similar symptoms but is caused by different reasons. Because the treatments for achalasia and pseudoachalasia are different, it is important to correctly diagnose each condition. At this time, there is no way to distinguish the two with the current tests used at Johns Hopkins.
Amyl nitrite relaxes vascular smooth muscle and has been studied previously as a potential means to separate achalasia from pseudoachalasia. Amyl nitrite is approved by the Food and Drug Administration (FDA) for the treatment of cardiac angina. It is not approved for use in motility testing and its use in this study is considered investigational. Investigators hope that the results from the proposed study could have significant clinical implications for patient management by helping doctors distinguish between achalasia and pseudoachalasia and allow them to choose appropriate treatment.
Patients with dysphagia (difficulty swallowing foods) undergoing routinely scheduled high resolution esophageal manometry (HRM) may join this study.
Detailed description
A single center, prospective study at a tertiary-care referral center (JHH). All patients will be provided with informed consent to undergo HRM with provocation as part of routine care to evaluate dysphagia symptoms or evaluation of known achalasia. All procedures will be performed as part of routine care and therefore no procedures will be performed for the purposes of research specifically.
Primary Objective: To determine the diagnostic advantage of the addition of the provocative amyl nitrite test in patients with dysphagia undergoing high resolution esophageal manometry (HRM)
Secondary Objective:
- Measure change of LES pressure after amyl nitrite inhalation in patients with dysphagia undergoing high resolution esophageal manometry (HRM)
- To assess the ability of amyl nitrite inhalation to differentiate achalasia from pseudoachalasia
- To assess the ability of amyl nitrite inhalation to differentiate partial fundoplication-related dysphagia versus that due to recrudescence of achalasia in patients who have undergone a prior myotomy.
- To assess the ability of amyl nitrite inhalation to differentiate post-fundoplication dysphagia from a newly diagnosed motility disorder in patients who have undergone a fundoplication for gastroesophageal reflux disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amyl Nitrite | Experimental | Drug: Amyl NitriteAmyl nitrite is the chemical compound with the formula C5H11ONO. It relaxes vascular smooth muscle.The method of administration is via inhalation with onset of action within of 30 seconds and ends 2-3mins. In a study by Dodds et al., amyl nitrite is used as part of radiologic esophagram test in order to distinguish patients with pseudoachalasia from those with idiopathic achalasia since amyl nitrite has transient effect on the lower esophageal sphincter (LES). The study revealed that the LES pressure in achalasia patient decreases substantially in response to amyl nitrite with the measurable increase in LES diameter of 3 mm to an average of 4.6m. In contrast, amyl nitrite does not relax the LES segment in pseudoachalasia and has no change in LES diameter. Thus, the investigators anticipate amyl nitrite inhalation will be beneficial at the LES during HREM. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-80 years old
- symptoms of dysphagia or a known history of achalasia
Key exclusion criteria (4 listed)
- Patients with comorbidity and contraindications to use of amyl nitrite inhalation: Glaucoma, Recent head trauma or cerebral hemorrhage, Hypotension, Concurrent use of nitrite, Pregnancy, Aortic stenosis, Patients with increased intracranial pressure, Caution in patients with coronary artery disease, Pulmonary hypertension
- Non-English speakers
- Patients <18 years old
- Those who lack capacity to give consent
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 |
|---|---|---|
| Amyl NitriteAmyl nitrite is the chemical compound with the formula C5H11ONO. It relaxes vascular smooth muscle; decreases venous ratios and arterial blood pressure; reduces left ventricular work; decreases myocardial oxygen consumption. The method of administration is via inhalation with onset of action within of 30 seconds and ends 2-3mins. In a study by Dodds et al., amyl nitrite is used as part of radiologic esophagram test in order to distinguish patients with pseudoachalasia from those with idiopathic achalasia since amyl nitrite has transient effect on the lower esophageal sphincter (LES). The study revealed that the LES pressure in achalasia patient decreases substantially in response to amyl nitrite with the measurable increase in LES diameter of 3 mm to an average of 4.6m. In contrast, amyl nitrite does not relax the LES segment in pseudoachalasia and has no change in LES diameter. Thus, the investigators anticipate amyl nitrite inhalation will be beneficial at the LES during HREM. | Drug | Amyl Nitrite |
Primary outcome
Measure LES pressure after amyl nitrite inhalation in patients with dysphagia undergoing high resolution esophageal manometry (HRM)
Time frame: 3 months
2 secondary outcomes
Measure Blood Pressure and Heart Rate at baseline and after administration of amyl nitrite
Time frame: 1 month
Number of Participants with Adverse Events with amyl nitrite inhalation
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
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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.
Ellen Stein, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amyl Nitrite in people with Dysphagia and Achalasia, run by Johns Hopkins University at 1 site in United States.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 30 Sep 2019. 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 United States. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Measure LES pressure after amyl nitrite inhalation in patients with dysphagia undergoing high resolution esophageal manometry (HRM) (time frame: 3 months). 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 30 Sep 2019.