- HCMA Newsletter Archives
- HCMA Fundraisers
- Patrons and Supporters
- My HCM Experience - The Faces of HCM/Share Your Story
- Founders Blog "Big Hearted Blog"
- Is it acceptable to bully the disabled?
- To tell or not to tell: My choices regarding clinical trials
- June 16 the day, I lost part of my mind and part of my heart
- Getting to the Heart of the Matter
- Life with HCM - How we lie to hide our pain
- When a loved one dies suddenly... again and again and again
- Why it is important to know what those letters after a doctor's name mean?
- The Day that changed my life
- The Affordable Care Act: Working to provide care!
- 24 weeks as a clinical trial participant... a look back and forward!
- Lisa, We have your heart. How soon can you be here?
- Tell me what it is you plan to do with your one WILD and PRECIOUS life?
- Life with a Pre-existing Health Condition Pre ACA
- The Day that Changed my life - June 12, 1995
- Is it the “Better Care” Act or a shell game?
- Reunited with my best friend and worst enemy
- Heart,soul... and a little prayer
- Thankful for the gift of bravery
- The Last Gift
24 weeks as a clinical trial participant... a look back and forward!
It took a great deal of thought as to how I was going to communicate my clinical trial experience with this blog. I gave a great deal of information heading into this decision and told you all that I would keep you updated. However, after careful thought a step-by-step valuation or evaluation was not really what I thought was in the best interest of my experience in a clinical trial, frankly I thought it best to not think about it much at all. Therefore, I thought I would wait until I concluded study and give a wrap-up of my experience.
I have not sought approval from any authority to communicate my experience; by this I mean I did not seek, permission from the drug company that was running the trial nor the physicians running the trial. Once again I remind you all, the choices I made were for ME, not for others to follow or feel pressured in anyway to participate in this or other trials, it is simply my experience and that I feel important to share.
I had to be at the hospital every six weeks for this particular trial. Each appointment varied and at a minimum it included blood draw, urinalysis, EKG and a conversation with the coordinator. The most extreme appointments included a VO2 max stress test, Zio patch, echocardiogram, ICD interrogation, bloodwork, urinalysis, EKG, and conversation with a nurse. Nothing was painful, nothing was terrible although I was not particularly thrilled with the patch when I had to wear it.
From an emotional standpoint, participating in the trial was,to me, rather easy. I found comfort and encouragement in the fact that the clinical trial even existed and that I was doing my part to help the broader community. Psychologically, I told myself I was on the placebo arm, told myself this pretty much every day when I took the pills as I referred to them as my M&M’s. I did not change any of my personal habits during the time I participated in the trial - I ate the same way, I exercise the same way, I had a glass of wine when I wanted one and all around I was acting exactly as I was prior to participation in trial.
I have been public about previous test results so rather than have people dig through message board posts or Facebook posts etc. to try to piece the story together been laid out for you right here. Approximately 5 years ago, I learned that my ejection fraction was dropping which is not a good sign HCM. Shortly thereafter I did my first VO2 stress test which indicated my result was a 17.2, not low enough to get me on a transplant list and not high enough to live in normal quality of life. I tried to fix myself - I change my eating habits I went to the gym four times a week I built myself up as best I could and about 18 months later I repeated the test and I increased my number to 18.1. I was quite disheartened by this number as I worked so hard to drop weight to prove my health and statistically my number was pretty much the same. I retained my healthy eating habits and am more active then I was 5+ years ago - and do not regret these changes - but they didnt really change my long term progression.
About three years after that last test I entered this study. The study required that you performed a VO2 stress test as part of the inclusion criteria. My entry number was again 17.2. I was admitted into the study and at the 12-week mark, I had my second VO2 stress test at which time I scored 18.6. I have to admit I was very happy with the improvement and not having changed any of my daily functions, other than of course taking one M&M every morning. At the 12 week, mark redoubled my dose so I began taking two M&M's every morning. Last week I took my final VO2 stress test by test results stunned me. I scored a 22.6.
As point of clarity for a 47-year-old woman a good VO2 is between 29.0 and 32.8, a fair number is 24.5 to 28.9 a poor number between 21 and 24.4 and a very poor number is under 21. Therefore, for point of clarity I am stunned and excited to be moving from very poor to poor however, it is a significant improvement and more distance between a transplant and myself.
Was it the drug? Was it the M&M's? Was it the power of the human mind simply participating in a clinical trial that has brought me an improvement? Was it nothing but chance?
I do not have the answers to any of these questions and will not until the conclusion of the trial. I am okay with waiting. I choose to remain very cautiously very optimistic that we may finally have something in toolbox of treatments for hypertrophic cardiomyopathy that truly improves quality of life for those with non-obstructive disease.
There are other clinical trials underway. I encourage each one of you to look at each trial and ask yourself “can I participate?”. Do I meet the inclusion criteria? Moreover, am I willing to sacrifice some of my time to help our HCM community?
I am very happy to have participated in this clinical trial regardless of the minor inconveniences and I hope and pray that the results help us understand HCM a little bit better.
Wishing you good health and happiness!
Sincerely your bighearted blogger,