As you may recall, I have been in a clinical trial since late December 2019 to test a potential heart failure drug known as omecamtiv mecarbil. The trial that I am involved in is known as Meteoric - HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure).
As is true I think with all trials, there have been other phases of the trial.
In this case, probably the most notable was GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure). This phase 3 study was to evaluate whether treatment with omecamtiv mecarbil, when added to standard of care, reduces the risk of heart failure events (heart failure hospitalization and other urgent treatment for heart failure) and cardiovascular death in patients with heart failure with a reduced ejection fraction. The patients in this country were either hospitalized at the time of enrollment for a primary reason of heart failure or had a hospitalization or admission to an emergency room for heart failure within one year prior to screening. While I do have a very reduced ejection fraction, I was not otherwise qualified to be in the Galactic clinical trial.
But Meteoric – HF was designed to evaluate the effect of treatment with omecamtiv mecarbil compared to a placebo on exercise capacity. This trial seemed right up my alley, as I love to exercise, and would do anything to positively impact my heart failure and reduce my exercise capacity. After a series of tests, I was deemed eligible and entered the study. As I have mentioned many times, my study team and I do not know whether I have the investigational drug or a placebo. But I feel great, with more energy and stamina, so whatever it is – real drug or placebo effect – I’ll take it.
I mentioned a few weeks ago that I was afraid that I would my participation in the trial would end early in because of all the shutdowns related to the pandemic. But in a very brief, drive-through appointment at the hospital, I received enough drugs to take me through the remainder of my trial – which ends around May 20.
Several weeks ago, I had an on-line appointment with my heart failure doctor. We talked about a number of things, to include my experiences during the trial. I told him my ability to exercise in our building’s fitness center had been impacted, and I was a little down that I couldn’t get as much activity in as I had pre-pandemic to improve my energy and stamina even more. But I also said that I was getting out early in the morning for a good long walk, finding as many inclines as I could to test my stamina, and that I was still feeling well and less fatigued.
The doctor asked me when the study ended, and if I was going to be doing another cardio pulmonary exercise test (CPET). The CPET would show if there really has been any improvement in my exercise capacity since I started the trial. I told him that the study team had indicated that because the part of the hospital I would have the test was also where Covid patients were seen, it would not be a good idea for me to come in for the test. However, the heart failure doctor told me that the heart and vascular treatment area was being reopened for heart and vascular patients only, and he indicated that I might be able to do the test after all in that portion of the hospital. He said that he would talk to my study coordinator.
Later in the week, the study coordinator contacted me to see how I was doing on the drug. She indicated that she had indeed talked to my heart failure doctor and the subject of the CPET had come up. However, the problem now was not whether the CPET could be conducted in an area that did not have access to Covid patients. Instead, there were no pulmonary specialists who would be available to conduct the test. I don’t know if the lack of pulmonary specialists is related to the fact that they would be working with patients who have Covid 19 respiratory issues, but I suspect it is.
However, the study coordinator indicated that they were considering extending my trial. This would allow me to take additional drugs. Hopefully, at the end of the extension then there would be a pulmonary specialist available to conduct the CPET. I am still waiting to hear back from the coordinator regarding whether the extension of the trial will occur. I think this has to be approved by the people who are overseeing the nationwide trial.
In the meantime, I googled Meteoric-HF on Friday. I am not sure what caused me to do this, other than thinking that there might be news on how the pandemic was impacting the clinical trial. But instead, I got some very surprising and what I think is good news. On that date, Amgen and Cytokinetics Incorporated issued a press release regarding the drug omecamtiv mecarbil. These companies are responsible for the clinical studies of the drug.
The press release announced that: “The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin activator, also known as a cardiac myotrope,1 being developed for the potential treatment of chronic heart failure with reduced ejection fraction (HFrEF).”
Just exactly what impact does a fast track designation have on the approval of a drug? According to the FDA website, “Fast track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.” Some examples of the type of conditions that are deemed as serious include AIDS, Alzheimer’s, heart failure and cancer.
Here are the criteria a drug under development must meet to show that it will address an unmet need:
From personal experience, I think that any drugs that can help improve the heart’s pumping function definitely meet the unmet need criteria. Heart pumping tops the list of the things a body needs to function. Plus, if your ejection fraction is reduced to such an extent that you may at some point be looking for a heart transplant – well that would seem to be an important unmet need as well. Additional support for my theory is that the relatively new heart failure drug Entresto also received a fast track designation. I couldn’t find any description as to how much a fast track definition speeds up the approval process. But it seems a better option than remaining on the regular timetable with scores of other drugs.
In anticipation of knowing what to expect when the trial ends, I asked the heart failure doctor what I could expect if I am really taking the investigational drug and then I stop taking it. That is a question that does not have an answer that is easy to predict. I could possibly still feel like I had more energy and stamina; or feel like I still had more stamina for three months and then it would fade; or maybe I would feel less energetic as soon as the drug was discontinued. I guess a lot depends on whether I was on the real drug and it did some serious remodeling of my heart. Because if that occurred, it would seem that the positive effect would remain. I have no clue what the impact is when you stop a placebo and you benefited from the placebo effect. Does that benefit continue even though you are aware of the fact that you did not have the real drug? Depending on whether they decline to extend my trial, I may be experiencing what the answer is in the near future.
All I know is that I hope the makers of the drug and the FDA keep this train running down the track at warp speed and gain approval. This would allow a greater population of us heart failure patients to have the opportunity to benefit from this new drug. That would indeed be a blessing.
Melanie discovered that she had heart failure in 2013. She spent the next 7 years learning how to live with the condition, and how to achieve balance and personal growth. Then in October 2020, she received a heart transplant. This blog is about her journey of the heart.