Becoming a warrior in the heart failure version of Star Wars!

I had a heart failure doctor appointment at the end of October.  The doctor talked to me about a trial for the investigational drug known as Omecantiv Mecarbil.  I know – this is a mouthful.  As this drug is just being studied, it does not yet have a name that easily rolls of your tongue. 

I found a description of this investigational drug on the Cytokinetics website.  Cytokinetics is a biopharmaceutical company.  It is collaborating with Amgen to develop this new drug, along with “funding and strategic support from Servier.”   Not sure what that part means but it sounds impressive, and as a heart failure patient, I’m glad when companies collaborate, fund and support new heart failure drug development.
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Here is what they hope the drug will do  (warning:  This description is the equivalent of four mouthfuls): 

• Omecamtiv mecarbil stimulates cardiac myosin, a protein responsible for converting chemical energy into the mechanical force that results in contraction of the heart. It is designed to improve cardiac muscle performance, potentially helping patients preserve cardiac function and quality of life, avoid hospitalizations, and decrease the risk of death due to heart failure. Preclinical research has shown that cardiac myosin activators increase cardiac contractility without affecting intracellular myocyte calcium concentrations or myocardial oxygen consumption.

I believe what this means is that the drug, if successful, will improve the heart’s pumping ability.

A previous phase of the study evaluated the drug in chronic heart failure and left ventricular systolic dysfunction. The name of this phase is “Cosmic–HF”.  Another phase focused on lessening adverse cardiac outcomes.  The name of this phase is “Galactic–HF”.  The research study my doctor talked to me about would evaluate exercise tolerance in heart failure patients.  The name?  If you are sensing a planetary/Star Wars type theme, you may have guessed it:  “Meteoric-HF.”

There are  many reasons I decided that I wanted to become a part of this study:  (1) I have the type of heart failure that the drug might help; (2) if they are looking for someone who can follow study instructions to the letter, I’m that gal; (3) I love to exercise and would love to have a drug that might improve my heart’s ability to pump and boost my exercise routines; and (4) I want to actively participate in something that could improve the lives of many heart failure patients, not just me.

I have begun the process of determining if I am qualified for the study.  A few weeks ago, I had some blood work done.  Based on those results I was able to get the first appointment with a research study coordinator and the doctor leading the study.  At that appointment, I reviewed and signed a comprehensive consent form package; went over my medical history and medications; had an EKG; had a physical exam; and had more blood work done. 

The blood work included a test called the “Pro BNP”.  What is that?  Here is the description that I found on the Cleveland Clinic website:

• B-type natriuretic peptide (BNP) is a hormone produced by your heart. N-terminal (NT)-pro hormone BNP (NT-proBNP) is a non-active prohormone that is released from the same molecule that produces BNP. Both BNP and NT-proBNP are released in response to changes in pressure inside the heart. These changes can be related to heart failure and other cardiac problems. Levels goes up when heart failure develops or gets worse, and levels goes down when heart failure is stable. In most cases, BNP and NT-proBNP levels are higher in patients with heart failure than people who have normal heart function.

I had this test performed twice recently at another lab.  The research coordinator told me that this time, if my result was under 300 (I can’t remember the standard of measurement), I would not be able to get into the study because I guess that would put me in the “normal” range.  I told her that the last test showed that I was way above that number, so I expect that I will still be in the running after they get the most current result. 

If I pass the blood work and urine tests, then the next step will be for me to have a cardio pulmonary exercise test.  This is my least favorite test.  It’s the one where you blow into a vacuum cleaner tube for an extended time.  The first test makes you blow all your air out of your lungs into the tube, which in me results in intense coughing fits.  The second test entails blowing hard and fast into the same tube and getting to the point where you almost hyperventilate.  Not a lot of fun.

Then you hop onto a treadmill and get fitted with a mask and then you begin your walk on the treadmill.  The speed and the incline gradually increase.  While I don’t like the pulmonary tests, I really hate the treadmill test.  Why?  Because it shows me how far my physical condition has slipped since I blacked out while exercising 7 years ago. 

The purpose of the mask you wear is to track your VO2 score.  What is that?  According to the Physical Therapy website of the Bon Secours  (bonsecoursphysicaltherapy.com):

• VO2 Max, short for maximal oxygen uptake, is the measure of an individual’s maximum capacity to transport and utilize oxygen during exercise. Also known as aerobic capacity, VO2 max is usually expressed as liters of oxygen per minute. It is a measure of your capacity to generate the energy required for endurance activities and is one of the most important factors determining your ability to exercise for longer than four to five minutes.

How does this test work?  According to the University of Virginia School of Medicine website (med.virginia.edu):

• By putting a face mask on the subject, we can directly measure the volume and gas concentrations of inspired and expired air. This measure is often used in research and is considered the most accurate. The test involves either exercising on a treadmill or a bike at an intensity that increases every few minutes until exhaustion, and is designed to achieve a maximal effort. We also obtain the individual’s maximal heart rate from this test, which, along with resting heart rate, can be used to develop a more precise target heart rate range. This is more accurate than age-predicted equations. Thus, the subject leaves the lab with an excellent idea of his/her current fitness level and also how to use this information to improve fitness.

 
My understanding is that a patient is disqualified from the study for being too healthy, i.e., having a score that is too good.  But it your score is too far in the opposite direction, you can also be disqualified which I guess means you are not healthy enough for the test.  Of course, I exercise regularly, do not have some of the issues of other heart failure patients, and according to most people I meet I look "normal" (whatever that means).  So it is probably not surprising that a concern was raised at my appointment that I might be too healthy. 

Of course looks are not everything, and if folks lived inside my body for a while they would realize that physical activity does not come without a lot of effort and sometimes inclines and stairs are harder than others.  Most important, last year, my heart failure doctor was concerned about a result in my cardio pulmonary stress test - something about the slope of the incline being too steep (not sure but I suspect it connects to the whole VO2 Max calculation).  So because of that concern marker he laid down last December, my thoughts run in the opposite direction  – that is, I'm concerned I may be too unhealthy.  Hopefully the Entresto I started taking last December will help.  Of course, if I should score out as too healthy, that might be a good sign that the Entresto is working well. 

The anxious worry wart in me is trying to make peace with the fact that whatever will be will be.  Still, I think because of my persistence and discipline I would be the ideal patient to be in the study.  I would not even care if I got the placebo instead of the investigational drug.  I just want to do something that will advance the drug options forward so that we have more chances to avoid heart transplants and left ventricular assistive devices (LVADs).

If I get into the study, what can I expect?  It lasts approximately 6 months.  There will be periodic blood tests.  At some points during the study, the patient will be asked to wear an actigraph, which I think is the medical field’s version of a fitness tracker.  Actually, with the star wars theme going on, I’d prefer a light saber, but I guess this is the only intergalactic technology I get.

At some point, study participants may be asked to do an interview – and get paid for it.  In my case, I think more people would pay for me not to talk so what a great opportunity for me!  At the end of the study, the patient will do another cardio pulmonary exercise test.  I guess this is to see if there was any improvement in the VO 2 max score as a result of the patient’s participation in the study.

​As I said, whatever happens – whether I get into the study or not – life will go on and there will be other opportunities to maybe help this weak heart.  What I am telling all my friends is that what I love best about this research study is the name: Meteoric-HF.  I figure that f I get in, I will either soar through the sky like a flaming meteor, or I will crash and burn into the earth.  Either way, it will be an epic experience!