Tag: ACC

Exercise and HCM: Not Enemies Anymore

Published on by hcmbeat1 Comment

Lots of good news for active HCM patients was presented at last weekend’s 23rd Annual American College of Cardiology Scientific Sessions.

The long-awaited results of the LIVE-HCM study were presented, and the results were quite reassuring for HCM patients who are vigorous exercisers.

This study followed 1534 HCM patients between the ages of 8 and 60,. Most participated in various forms of exercise over the three year period of the study, such as running, swimming and basketball.  The study also included 126 participants who carried a gene associated with HCM, but did not show overt signs of the disease. 42% of study participants exercised vigorously, 43% exercised moderately, and 16% were not active.

Contrary to an older school of thought which cautioned against vigorous exercise in HCM patients, the results of the study showed NO increase in cardiac arrests, ventricular arrhythmia or fainting among the vigorous exercisers, disproving the long held assumption that vigorous exercise was dangerous for patients with hypertrophic cardiomyopathy.  Also, the study found no cardiac events occurring among the group who only carried a gene for HCM but did not have the disease.

According to Dr. Rachel Lampert of the Yale School of Medicine who was the lead investigator of the study, the data from this study “does not support restriction of vigorous exercise for individuals with HCM.”  Dr. Lampert also spoke about the benefits to health of exercise in general, and the need for shared decision-making between HCM patients and experienced HCM physicians when making decisions around exercise.

You can see this video of Dr. Lampert talking about the LIVE-HCM study.

And in other good news for HCM athletes, another paper supportive of competitive sports in patients with genetic heart disease was presented at ACC23.  This presentation showed that 95% of competitive athletes who played at the Division 1 or professional level who elected to return to play after being diagnosed with a genetic heart disease did not experience cardiac events such as fainting, seizures, ICD shocks, sudden cardiac arrests or sudden cardiac death.  Again, focusing on the need for shared decision-making and risk stratification with an expert, the researchers believe that with a comprehensive return-to-play protocol including a personal AED, annual follow-ups and continued risk evaluation, together with coordination with team and/or organization medical staff, a return to competitive sports may be possible.

Comprehensive risk assessment, combined with shared decision making around the decision to participate in sports, seems to be the way of the future.  It is an important concept that was included and discussed in the 2020 ACC/AHA Guidelines for the Diagnosis and Treatment of HCM and represents an important advance for patients.

Cytokinetics Teases Upcoming Phase 3 Aficamten Trial in nHCM

Published on by hcmbeat1 Comment

A Phase 3 clinical trial aimed at the non-obstructed HCM population (nHCM) appears to be planned for Cytokinetics’ next-generation myosin inhibitor, aficamten.

Based on positive data from Cohort 4 of the Phase 2 REDWOOD-HCM trial, Cytokinetics is planning to soon launch a Phase 3 clinical trial for non-obstructed hypertrophic cardiomyopathy.  Non-obstructed HCM patients are a group whose only current treatment options are diuretics, beta-blockers, and other drugs used in the traditional heart failure setting.  In extreme cases, heart transplantation may be the only path available to these patients.

According to data presented on Sunday at the American College of Cardiology 72nd Annual Scientific Sessions (held in my beloved hometown of New Orleans, the city with the best and least heart-healthy food in the world), 41 patients with nHCM in the cohort showed improvement to both their NT-proBNP and troponin levels (both are biomarkers of heart wall stress seen in blood tests). And, the drug was generally well tolerated.

Separately, data was presented showing that obstructed HCM (HOCM) patients who took aficamten for a 48 week period showed significant improvement to their left ventricular outflow tract gradients (LVOT) while 88% of patients experienced improvement of at least one NYHA Functional Class.

All 19 HOCM patients enrolled in the trial who fit the eligibility criteria for septal reduction therapy (septal myectomy or septal alcohol ablation) at the start of the trial improved so much that they were no longer eligible after 48 weeks on aficamten.

It would be wonderful to have better options for the treatment HCM, so here’s hoping that aficamten continues down the road to FDA approval.

For more about aficamten, read these prior posts from HCMBeat:

2 Companies Testing Drugs for HCM

HCM Clinical Trials – the Latest News

The Future of HCM Care

Positive Signs from REDWOOD-HCM

Promising Data about Aficamten Presented at Meetings

More on Aficamten & Mavacamten from ACC 2022

Aficamten Updates from Cytokinetics

Aficamten Gets “Breakthrough Drug” Status from FDA

Cytokinetic’s Drug Aficamten & Upcoming HCM Summit – Interview with Dr. Martin Maron

Results Published from REDWOOD-HCM Phase 2 Trial

The Future of HCM Treatment

More on Aficamten & Mavacamten from ACC 2022

Published on by hcmbeat6 Comments

In addition to the presentation of the results of the VALOR-HCM study which compared mavacamten to septal reduction techniques, covered here in its own HCMBeat blog entry, ACC 2022 featured two other presentations about the new class of drugs known as myosin inhibitors, such as Bristol Myers Squibb’s mavacamten and Cytokinetics’ aficamten.

Continue reading “More on Aficamten & Mavacamten from ACC 2022” →

VALOR-HCM Trial – Mavacamten vs. Septal Reduction Therapy – RESULTS ARE IN!

Published on by hcmbeat5 Comments

The Phase 3 VALOR-HCM trial results were presented this morning at the American College of Cardiology annual meeting in Washington, DC by the principal investigator, Dr. Milind Desai of the Cleveland Clinic, and the results are good!

What was the VALOR-HCM study?

15 – 20  million people worldwide are estimated to have HCM, with 2/3 of this group having the obstructive form which can cause severe symptoms. Historically, these patients have been treated with medications approved for other conditions, and if those don’t relieve symptoms, they are referred on for septal reduction therapies (SRT) like alcohol septal ablation (a catheter based procedure) or septal myectomy (open heart surgery), which are invasive therapies requiring specialized care and which are not widely available.

The VALOR study was designed to compare mavacamten head to head with SRT to see if mavacamten could be a non-invasive treatment alternative for obstructive HCM.

Continue reading “VALOR-HCM Trial – Mavacamten vs. Septal Reduction Therapy – RESULTS ARE IN!” →

ACC Focuses on HCM with Cover Story

Published on by hcmbeatLeave a comment

The July edition of the the American College of Cardiology’s magazine features a cover story about HCM. 

The article surveys the history of HCM and then moves through the evolution into contemporary treatments.  The article also contains a summary of important topics from the new 2020 AHA/ACC Guidelines and highlights EXPLORER-HCM, the recent groundbreaking clinical trial of mavacamten. 

Check it out when you can.

2020 AHA/ACC HCM Diagnosis & Treatment Guidelines Released – Updated With New Links

Published on by hcmbeat7 Comments

The highly anticipated 2020 American Heart Association/American College of Cardiology Guidelines for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy have been released.

This document, drafted with reference to published HCM literature, and with input from a committee of HCM experts with broad expertise, updates the prior version published in 2011.  It contains clinical practice guidelines for the broad spectrum of issues which may confront medical professionals as they approach the diagnosis and treatment of patients and families affected by hypertrophic cardiomyopathy.

Continue reading “2020 AHA/ACC HCM Diagnosis & Treatment Guidelines Released – Updated With New Links” →

ESC Risk Assessment Tool Comes Up Short in Study

Published on by hcmbeat6 Comments

A recent study published in the American Journal of Cardiology found that the standards propounded by the American College of Cardiology Foundation with the American Heart Association (ACC/AHA) were superior in predicting which patients would benefit from an implantable cardiac defibrillator (ICD) compared to the calculator set forth by the European Society of Cardiology (ESC).  According to the study, the use of the ESC tool will result in more high-risk patients going unprotected against sudden death.

Specifically, the study found that out of a group of 288 HCM patients, 14 who experienced aborted sudden cardiac arrest (or 43%) would not have qualified for an ICD under the ESC risk model compared to 7% of patients under the ACC/AHA guidelines.

The ACC/AHA guidelines are:

ICD Guidelines rev.

A companion editorial by Dr. Andreas S. Barth pointed out the shortcomings of both models, and reaffirmed the necessity for shared decision making between physicians and patients.  Dr. Barth also expressed hope that a more accurate predictive model will evolve, though he acknowledged the impossibility of designing a model which could predict future events with certainty.

 

HIGHLIGHTS FROM THE INTERNATIONAL HCM SUMMIT VI, PART II

Published on by hcmbeat5 Comments

**Because so much HCM information was presented at the Summit, this is the second of multiple blog entries.  Stay tuned to HCMBeat for more highlights from the HCM Summit.  To see Part I of this series of highlights from the HCM Summit VI, click here.**

The 6th International HCM Summit was held October 27, 28 and 29th in Boston, Massachusetts.  This symposium brings together HCM professionals from around the world who are there to learn about and discuss the latest developments in the treatment of HCM.

The symposium was organized by long time HCM expert Dr. Barry Maron and his son, Dr. Martin Maron.  Both Marons are now affiliated with Tufts Medical Center’s Hypertrophic Cardiomyopathy Center.

What follows are summaries from selected talks presented at the meeting.  The presenter and their hospital affiliation are noted below, along with the topic of their presentation.  When possible, you may access the presenters’ slides via hyperlink by clicking on the name. (Note that not all presenters made their slides available).

Continue reading “HIGHLIGHTS FROM THE INTERNATIONAL HCM SUMMIT VI, PART II” →