Current Clinical Trials

LANAIS-HF: Specimen Collection for the Evaluation of Alere NT-proBNP for Alinity i System in an Outpatient Setting for Heart Failure
  1. Damon Kelsay, MD
    Damon Kelsay, MD
  2. for people 18 and up (full criteria)
  3. Rancho Mirage, CA
  4. study started September 2021
  5. Damon Kelsay, MD
  6. Accepting new patients

Description

Summary

The objective of this study is to collect and bank K2-ethylenediaminetetraacetic acid (K2EDTA) plasma to evaluate the clinical utility of the Alere NT-proBNP for Alinity i system assay as an aid in the diagnosis and assessment of severity of individuals suspected or having heart failure. The assay is further indicated for the prognosis of patients with HF (heart failure hospitalization and long-term event rates at 6-months and 1-year). Device Category: B Non-Experimental/Investigational Risk Level: Non-Significant Risk (NSR) Device Class: N/A

Official Title

LANAIS-HF: Specimen Collection for the Evaluation of Alere NT-proBNP for Alinity i System in an Outpatient Setting for Heart Failure

Keywords

Heart Failure

Eligibility

for people 18 and up
Inclusion Criteria: 1. At least 18 years of age 2. Subjects presenting to the outpatient site with signs or symptoms consistent with clinical suspicion of new onset of heart failure, or patients with structural heart disease, per ACC/AHA Heart Failure Stage B classification. • Symptoms may include dyspnea (shortness of breath), orthopnea (difficulty breathing when lying down), paroxysmal nocturnal dyspnea (shortness of breath while sleeping), reduced exercise tolerance, fatigue, bilate... more
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Inclusion Criteria:

1. At least 18 years of age
2. Subjects presenting to the outpatient site with signs or symptoms consistent with clinical suspicion of new onset of heart failure, or patients with structural heart disease, per ACC/AHA Heart Failure Stage B classification.
• Symptoms may include dyspnea (shortness of breath), orthopnea (difficulty breathing when lying down), paroxysmal nocturnal dyspnea (shortness of breath while sleeping), reduced exercise tolerance, fatigue, bilateral peripheral edema
• Signs may include tachycardia, tachypnea, pulmonary rales, increased jugular venous pressure, hepatomegaly, gallop rhythm
3. Willingness to sign informed consent

 

Exclusion Criteria:
1. Subjects with known acute HF or known exacerbation of chronic stable HF (previous history of heart failure)
2. Severe renal insufficiency (stage 4 and 5 CKD; eGFR < 30 mL/min/1.73m2) requiring dialysis
3. Prior participation in this study or current participation in an investigational drug study (with the exception of other IVD blood tests)

 

Lead Scientists at Eisenhower Health

Damon Kelsay, MD
Board Certified in Internal Medicine and Cardiovascular Disease, Dr. Damon Kelsay received his medical degree and completed his residency and fellowship programs from Loma Linda University Medical Center.As a young boy, Dr. Kelsay always knew his vocation would involve medicine. Initially, he thought he would pursue a career in veterinary medicine. However, while interning and volunteering in a veterinary office while in high school, Dr. Kelsay didn’t like the notion of “putting down... more
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Board Certified in Internal Medicine and Cardiovascular Disease, Dr. Damon Kelsay received his medical degree and completed his residency and fellowship programs from Loma Linda University Medical Center.

As a young boy, Dr. Kelsay always knew his vocation would involve medicine. Initially, he thought he would pursue a career in veterinary medicine. However, while interning and volunteering in a veterinary office while in high school, Dr. Kelsay didn’t like the notion of “putting down” animals, so he redirected his interest in medicine to humans.

While in medical school, Dr. Kelsay became intrigued with cardiology. “The first time I listened to a heart murmur and saw an EKG, I was hooked on cardiology and haven’t regretted pursuing this specialty for even a moment,” states Dr. Kelsay. Over his career he has culled a special interest in invasive and non-interventional procedures, such as pacemakers, echo cardiology and device therapy.

In working with patients, Dr. Kelsay believes that patients should be active participants in their health care. “Patient outcomes are not as successful if the patient is not engaged and willing to do his or her part (quit smoking, exercise, proper nutrition). The ‘doctor-heal-me’ attitude doesn’t tend to work that well,” states Dr. Kelsay. “I manage chronic diseases that can be greatly affected and minimized with a combination of correct medication, devices, exercise and diet.”

Dr. Kelsay practices what he preaches. He works out regularly, is a vegetarian (although he doesn’t require that of his patients) and is an avid snow skier.

Clinical Study Details

  1. Accepting new patients
  2. study started September 2021
  3. March 18, 2024