Clinical trial: Do Acid Sensing Ion Channels Contribute to Heartburn? (NCT01095133)

Eligibility criteria:
Inclusion Criteria:

          -  Adults, 18-59 years old

          -  moderate heartburn at least 3 days/week

          -  males and non-pregnant/non-lactating females

          -  Complete relief while using a PPI or only some relief of symptoms while on a PPI

        Exclusion Criteria:

          -  erosive esophagitis

          -  unable or unwilling to undergo endoscopy and biopsy or Bernstein testing

          -  eosinophilic esophagitis

          -  negative Bernstein test

          -  known hypersensitivity to amiloride

          -  renal disease

          -  diabetes

          -  hypotension

          -  electrolyte imbalance

          -  contraindication to diuretics, including taking lithium or ACE inhibitors. -history of
             gastric or esophageal surgery

          -  history of ZE syndrome

          -  bleeding disorder

          -  UGI bleeding

          -  esophageal motor disorder

          -  esophageal stricture

          -  Barrett's esophagus

          -  UGI malignancy

          -  esophageal varices

          -  subjects with current malabsorption

          -  inflammatory bowel disease

          -  severe heart-lung-liver-renal-cerebrovascular disease

          -  subjects post-transplant

          -  diabetes

          -  actively taking the following medications: tricyclic antidepressants, quinidine,
             quinine, dilantin, warfarin, narcotic analgesics, antineoplastic agents, salicylates
             (except a baby aspirin for cardiovascular protection); steroids, NSAIDs (including
             COX-2 inhibitors), KCl, anti-tuberculosis medication, bisphosphonates, and
             triamterene, cyclosporine, tacrolimus, and other potassium sparing drugs like
             spironolactone

          -  serum potassium of 5.5 mEq/L or higher
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 59 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Contradiction