When I saw my heart failure doctor at my appointment on October 30, he indicated to me that the future for heart failure treatments is promising. There are some new drugs in the development and the investigation stage. Some of the drugs could make the patient feel better, others could improve the heart’s function.
He mentioned that the hospital that his program resides in currently has a clinical study for one of these drugs, and my name had been mentioned as someone who might be interested in that study. The drug under investigation is known as omecamtiv mecarbil, and the purpose of the drug would be to improve the heart’s pumping ability. My reaction was – where do I sign up?!?
He had someone associated with the study stop in and talk with me after my appointment ended. Again, I was ready to sign on the dotted line at that point, but she wanted me to take a consent package home with me to review. Of course, the lawyer in me also saw the benefit of informed consent – but the person with the crummy heart just wanted to move forward with a study! She told me that the coordinator for the study was out of the office but would reach out to me when she returned.
You might be curious regarding the name of this clinical study. It is Meteoric - HF. This is the third phase so far of the clinical study and the other two phases were called Cosmic - HF and Galactic - HF. I think they should issue light sabers for the study, but as of yet, that has not been mentioned as a possibility.
Notwithstanding the fact that I still had not talked to the coordinator nor read the consent package, there was a preliminary test that had to be performed to see if I was even eligible for the study. I needed to have a blood test for BNP (Brain Natriuretic Peptide). A few weeks before, I had been at the office of my primary care doctor to be treated for bronchitis. She had done some bloodwork, and I had printed off a copy of the blood tests that she had performed because I figured my heart failure doctor might want the results. It turned out that one of the tests was for BNP.
The nurse said she would reach out to the primary care doctor for the results. Unfortunately, what the nurse did not realize was that I needed a Pro BNP test. I know that I did not realize this fact. I am not sure but I think that the Pro BNP test was needed because I have been taking Entresto for almost a year. So, on Halloween, I had to go to a nearby lab for the Pro BNP test. A minor delay – but hey, if you’ve got to have blood work done, I guess a day devoted to ghouls and spooks and vampires may be as good a day as any.
A day or two later, I received a notice that the blood work had been returned and was available at my doctor’s office on-line. I think my result was something like 2000 units above the normal range. Yikes – now I wondered not only if I was eligible for the test, but if I was still alive! At the same time, I received a phone call from the study coordinator to schedule an appointment to discuss the study. I mentioned the Pro BNP result and that I was a little concerned. She said that she would have the nurse get in touch with me.
The nurse said BNP is a marker that measures the stretching of the heart ventricles and is usually chronically elevated in patients with heart failure. Normally the test is done when a patient has symptoms like shortness of breath and swelling. It is apparently performed to figure out the amount of fluid in their system. Though result showed that my number was elevated, I was stable from a symptoms point of view. I was having the test just to see if I was eligible for the study (which I was). Also, my doctor was aware of the results and was comfortable with the plan of care that was discussed during my office visit – so I breathed a big sigh of relief.
When I went to see the coordinator a week or so later, we went over the consent package for the study, which included the schedule of appointments that would be required if I was found eligible. My blood pressure had to qualify for the study, and I also had to perform a cardio pulmonary exercise test, which is my least favorite of the heart failure procedures. Happily, my blood pressure was in the eligible range at the first visit.
The coordinator also commented on several occasions that I did not seem like the typical heart failure patient. One reason she said this was because I am still a pretty active person. Plus, it was easy to draw the blood for my blood work which I interpreted to mean that sometimes it isn't so easy to draw blood from a heart failure patient. Finally, I didn’t take the major diuretic known as Lasik. I think she was concerned that I might be too healthy for the study. I was confident that despite how I look on the outside, I have a pretty flabby, non-energetic heart on the inside!
We went over all the language in the consent package – which was a lot being that there were 26 pages! It covered everything – what we would do at each appointment; a glossary of terms; the fact that some people would get a placebo rather than the investigational drug, and the percentages for each; what my rights were if I chose to be part of the study; what the risks were to me from being part of the study; the fact that I could elect to be interviewed twice during the study about the experience of having heart failure and the experience of being in the study, etc. I had already read the package several times at home, having received a copy after my doctor’s appointment at the end of October. My question ever since that time had been – when can I sign up? So, I was ready to sign.
After I signed the consent papers, I had an exam by the study doctor, who I will be seeing at a number of my appointments. I also learned that he would be at the cardio pulmonary exercise test. As I have mentioned in this post and others, I really do not like the test. It is performed in two part – the first one is two tests evaluating pulmonary function, one of which always leaves me coughing my guts out. Then you have to hop on a treadmill and wear a mask and electrodes while you walk.
You would think that since I walk on a treadmill many days as part of my exercise routine, I would love this test. You would be wrong. The test involves walking up an increasing incline at an increasing speed for as long as you can tolerate, or until the medical staff stops the test, whichever comes first. I hate the test because it shows me how my heart has deteriorated in a span of 7 years. But since I needed to do the test to qualify for the study which I really wanted to be in, and since I am required to do this test each year anyway, I was resigned to getting it over with. We scheduled the test for Friday, December 13.
When the day came for the test, I slept in and tried to chill (as much as a never reformed Type A intense person can chill). I gave myself plenty of time to get to the location where the test would be held. Happily, while not pleasant, I got through the pulmonary part of the test with less coughing than usual, probably because the technician had some helpful tips. Then she measured me for the mask for the test and I hopped on the treadmill.
There are two things that go on while the test is happening. First, as I said before the incline and the speed increase periodically. At the same time, they have to take your blood pressure throughout the test. Even though I had done this test about four times before, I noticed something different after the first few minutes: the incline seemed to be increasing more than the speed was increasing. I found out that this was because the clinical study uses a different protocol for the test.
The other thing was that it was really hard for the pulmonary technician to hear my blood pressure. I know that for the last 7 years, others have complained that it can be hard to take my blood pressure because it is very faint. So when you combine that fact with the noise made by the treadmill, it must have been really difficult to hear anything going on with my blood pressure. Fortunately, she let the doctor take over and he was able to get readings, so all was well.
At one point in the test I looked down and saw what I thought was a 13.5 percent incline and thought – “Whoa – I’m not sure it has ever been this high before. So, I think I’ll just ignore it!” About 12 minutes into the test, the doctor asked how I was doing. I said that I was beginning to feel a little short of breath. He asked if I wanted to stop the test and I said something like “No, because I don’t know if I have qualified for the study yet.” He told me they would be stopping it in a few minutes anyway. I thought I could last that long – and I did.
After the test was over, the coordinator told me that the results had to go to another institution that was monitoring the study for approval. She thought we would hear back by the end of the next week. In the meantime, she instructed me to wear an Actigraph watch she gave me. This watch is similar to a fitbit and tracks steps. The coordinator gave me a device with a cradle to hook it into after two weeks to both transmit the data and charge the watch.
She called me on Tuesday of the next week and said that I was found to be eligible. She asked me if I could come in Friday December 27 to be randomly assigned a drug that I would take during the study. I said yes. However, on December 23 she called me to say that the Actigraph people said that they had not received any data yet. Apparently, the device I received for purposes of transmitting was also a blue tooth device and if plugged in, would be transmitting data at various times even though I did not have the watch hooked into the cradle. So I plugged it in and put the watch in the cradle. But it was not transmitting.
I talked to a very nice woman at Actigraph who helped me try to figure out what the problem was. I had cell phone coverage which is what the blue tooth needed, but still I could not get it to transmit. The coordinator and the Actigraph representative and I decided that I would just take the watch and everything with me to my appointment. The representative told me that as long as the watch displayed a running man in the corner it was recording my data.
Happily, the data was all there and the coordinator was able to download it when I came in to have the drug assigned. I say happily because the Actigraph representative told me that they needed 7 days of data I guess to use for evaluation purposes before I could begin taking whatever drug they assigned. I actually had about 14 days of data on the watch. I will wear it at other points in the study, but for now, it is sitting in the charger until I need it again.
I have been taking the drug for a while now and I feel good. Hopefully I have the real drug and it is making my heart pump better. Of course, maybe I have the placebo but possibly have what is known as the “placebo effect”. The website medicine.net says:
Whatever – I feel good. If a placebo is helping me stay on top of the meteor that is this study, well I’m down with that!
Melanie discovered that she had heart failure in 2013. Since that time, she has been learning how to live with the condition, and how to achieve balance and personal growth.