Heart Preload Failure. The Harvard ME/CFS Collaboration at Harvard-Affiliated Hospitals

John Mac

John Mac

Senior Member (Voting Rights)
Not sure if this has already been posted.

Patient Studies
We propose to evaluate ME/CFS patients who have been identified as being impaired with PLF either by a single iCPET or by sequential iCPET. Our hypothesis is that at least a very significant portion of ME/CFS patients demonstrate PLF, which is a failure to increase ventricular filling pressures and venous return in response to exercise or they demonstrate PLF by either arterial venous shunting effects or defective oxygen uptake or mitochondrial oxygen utilization. We will evaluate large vessel vascular capacitance and blood volume. Additional diagnostic testing (i.e., screening for adrenal insufficiency, tilt-table testing, nerve conduction studies) and therapeutic intervention (i.e., hydration, increased sodium intake, β-adrenergic receptor antagonists, fludrocortisone, pyridostigmine, and/or midodrine), compression stockings, and monitored exercise training) will be employed based upon individual patient findings. Similarly, we will evaluate the presence of peripheral shunting and oxygen delivery or utilization.

In addition, longer term outcome evaluations will be conducted at 6 - 24 months follow up CPET/iCPET evaluations in those patients who consent. In those longer term outcome studies, improvements in ventricular filling pressures in response to exercise will be evaluated relative to any changes in the symptoms of dyspnea and fatigue with appropriate interventions. In the appropriate mechanistic circumstances, therapies will be tested and one of the outcomes will be the improvements in the iCPET findings.

Participation in the Studies
For the near term, the iCPET studies are conducted according to normal clinical indications. A biorepository for blood samples has been ongoing at the BWH for many years. There are plans to dig more deeply into the mechanisms that underlie both the low and high flow forms of the Preload Failure. For the moment, the best opportunity to participate in these activities are based upon the referral from clinicians for a clinical evaluation of a patient’s unexplained dyspnea and fatigue. Future studies are on the drawing board and will be updated as they become available.
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http://endmecfs.mgh.harvard.edu/heartpreload/
 
The website seems to be set up to post information about the Harvard section of the OMF ME/CFS research collaborative. I notice there is a Donate button at the bottom of each page.

I wish people would date things like this. There is no indication of when each article was published on the website, and whether this particular page is new news, and when the study described will happen, or any links to research protocols etc.

I can only assume the main purpose is fundraising.
 
Trish said:
The website seems to be set up to post information about the Harvard section of the OMF ME/CFS research collaborative. I notice there is a Donate button at the bottom of each page.

I wish people would date things like this. There is no indication of when each article was published on the website, and whether this particular page is new news, and when the study described will happen, or any links to research protocols etc.

I can only assume the main purpose is fundraising.
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I think you are right. I was guided to this page from a posting dated yesterday on the OMF site and they have started their fund raising campaign this week.
https://www.omf.ngo/2019/10/23/heart-preload-failure/
 
It sounds like a pretty muddled protocol if people are going to be given various treatments 'based on individual patient findings'.

I don't quite understand how they can find out if PWME often have preload failure if they are only studying people who have preload failure.
 
Jonathan Edwards said:
It sounds like a pretty muddled protocol if people are going to be given various treatments 'based on individual patient findings'.

I don't quite understand how they can find out if PWME often have preload failure if they are only studying people who have preload failure.
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I think this misses what I currently see as the point of the study. We have initial information on preload failure. As I see this the study is to get more information on the failure, including potential treatments, to find out which might be more likely to work with ME. The results of this kind of study should provide the information that will inform future studies. It will not be, from this study alone, applicable to all ME patients, nor provide evidence of optimal efficacy.

First, get data. We cannot necessarily rely on data on preload failure in non-ME patients. Then, develop hypotheses. After that it could follow the conventional research track.

I hope this will follow the Stanford open medicine approach. If so then that data will be available to others who can use it to develop their own hypotheses and studies.

This study will NOT lead to definitive findings on treatment.

PS If this study shows we match already existing findings on preload failure, then we have information that conventional testing and treatment for preload failure in ME patients might be effective, though it will still need a proper phase 3 trial to be sure.
 
I wish I were as optimistic @alex3619. I have been in exactly this situation myself with early hypothesis driven investigation and this does to sound like the way to go forward to me. I worry that the 'research' is driven by the constraints of private medicine to be honest.

In simple terms, to be meaningful, all numerators need denominators, free of bias.
 
OK, I'm confused about the study noted at the start of this thread - have I missed something?

I've been waiting for what I thought was a look at possible preload failure in pwME, that was to be funded by a patient's generous donation.

The study I have been waiting to see was announced last year, but to my knowledge has not started.

However, I've seen an article about several hundred people who have been studied re preload - many of whom have ME.

And, the article at the top of this thread talks about pwME already identified with PLF.

If I understand correctly, this article was done regarding clinical findings over the course of several years.


It seems this proposed study is a step further along than what had been proposed many months ago - finding possible PLF in pwME.

In the long run it doesn't really matter.

What's important is that this research happens.

Just a bit frustrating, and perplexing to follow the bouncing ball.
 
alex3619 said:
I think this misses what I currently see as the point of the study. We have initial information on preload failure. As I see this the study is to get more information on the failure, including potential treatments, to find out which might be more likely to work with ME. The results of this kind of study should provide the information that will inform future studies. It will not be, from this study alone, applicable to all ME patients, nor provide evidence of optimal efficacy.

First, get data. We cannot necessarily rely on data on preload failure in non-ME patients. Then, develop hypotheses. After that it could follow the conventional research track.

I hope this will follow the Stanford open medicine approach. If so then that data will be available to others who can use it to develop their own hypotheses and studies.

This study will NOT lead to definitive findings on treatment.

PS If this study shows we match already existing findings on preload failure, then we have information that conventional testing and treatment for preload failure in ME patients might be effective, though it will still need a proper phase 3 trial to be sure.
Click to expand...
I see this thread was from 4 years ago, approx. I was just reading the Preload Failure article (https://endmecfs.mgh.harvard.edu/heartpreload/), brought to my attention by another sometimes-participant in this site, because my most prominent symptom when I'm crashing is a feeling in my chest--hard to describe, but it's like I'm not getting enough oxygen. Sort of like coming out of general anesthesia when I've received a bit too much. It's not shortness of breath or what I'd call "air hunger." Just extreme fatigue, but with the primary locus being left of center in my chest. (I have had all cardiac testing available other that CPET; everything perfect according to my cardiologist.)

Any more word or info about this, anyone?
 
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