Preconditioning with Tefillin for Heart Disease

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jack Rubinstein

Must not be taking: Any medications

Disqualifiers: Active medical condition

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 days

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a unique approach to protect the heart from damage during a heart attack. It tests whether wearing tefillin, a traditional Jewish practice, can reduce injury when blood flow returns to the heart. The trial compares this method with applying capsaicin cream to the arm. Women not currently on medication or dealing with an active medical condition may be eligible to participate. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new heart protection strategies.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications to participate in this trial, as it excludes those who are currently using medication for any medical condition.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research suggests that wearing tefillin might be safe for the heart. Studies with Orthodox Jewish men, who regularly wear tefillin, have shown lower rates of heart-related deaths. Another study found that both men and women who wore tefillin experienced changes in heart rate that might indicate a protective effect. This is similar to ischemic preconditioning, often considered safe during heart procedures. Although tefillin is not a medicine, research suggests it could be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of tefillin for heart disease because it offers a novel approach that is quite different from existing treatments like medications, lifestyle changes, or surgeries. Tefillin, traditionally a Jewish prayer implement worn on the arm, is unique as it potentially provides cardiovascular benefits through a non-invasive and culturally significant practice. By creating intermittent pressure on the arm, tefillin might mimic the effects of ischemic preconditioning, which helps protect the heart from future stress. This innovative method could complement traditional heart disease treatments by introducing a ritualistic yet scientifically promising technique.

What evidence suggests that this trial's treatments could be effective for heart disease?

This trial will compare the effects of wearing tefillin with applying capsaicin cream. Research has shown that wearing tefillin, a traditional Jewish practice, can protect the heart. Studies have found that orthodox Jewish men who regularly wear tefillin experience lower rates of heart-related deaths. This benefit may result from "preconditioning," where the body adapts to short periods of reduced blood flow, increasing resilience to heart attacks. Wearing tefillin has also been linked to changes in heart rate that suggest a slower metabolism, which benefits the heart. Additionally, it affects heart rate variability, a factor associated with better heart health. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This clinical trial is for women over the age of 18 who are not currently taking medication for any medical condition and do not have an active medical condition. It's designed to explore a potential heart protection method observed in Jewish men wearing tefillin.

Inclusion Criteria

I am a woman older than 18.

Exclusion Criteria

I am currently taking medication for a health condition.

Active medical condition

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear tefillin in the traditional manner or apply capsaicin cream to the non-dominant arm

6 days

Daily visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tefillin

Trial Overview The study investigates whether using tefillin, which may induce 'preconditioning', can protect against heart damage during a heart attack. This concept comes from animal studies suggesting preconditioning reduces reperfusion injury when blood flow returns after being blocked.

How Is the Trial Designed?

Group I: Tefillin Experimental Treatment 1 Intervention

Wearing of tefillin in traditional manner

Group II: Capsaicin Active Control 1 Intervention

Applying cream to non-dominant arm

Who Is Running the Clinical Trial?

Jack Rubinstein

Lead Sponsor

Trials

2

Recruited

30+

Published Research Related to This Trial

The study found that non-obstructive banding (NOB) through the use of tefillin can induce a remote ischemic preconditioning (RIPC) response, which may help protect the heart from damage during ischemic events.

In a trial with 30 healthy subjects, NOB was associated with significant changes in heart rate variability (HRV) markers, suggesting that this method could be a potential clinical approach to reduce the risks associated with ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tefillin use induces preconditioning associated changes in heart rate variability. Koch, SE., Martin, E., Verma, A., et al.[2023]

In a study of 10 patients with variant angina, transient ischemic episodes were found to significantly protect against complex ventricular arrhythmias (CVAs) during subsequent ischemic events, indicating a potential therapeutic benefit of ischemic preconditioning.

The protective effect against CVAs was not linked to a decrease in the severity or duration of ischemia, suggesting that the mechanism of protection is a direct result of preconditioning rather than simply a byproduct of reduced ischemic stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconditioning by transient myocardial ischemia confers protection against ischemia-induced ventricular arrhythmias in variant angina. Pasceri, V., Lanza, GA., Patti, G., et al.[2019]

Preconditioning the heart through brief periods of ischemia has been shown to significantly reduce heart tissue damage (infarct size) and may be beneficial in patients with coronary artery disease, as evidenced by improved outcomes in those experiencing angina before a heart attack.

Certain drugs, like adenosine and potassium channel openers, have been identified as potential mediators of this preconditioning effect, suggesting they could be used to protect heart tissue during procedures like coronary angioplasty, although more research is needed before they can be widely applied in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of ischemic preconditioning. Schwarz, ER., Reffelmann, T., Kloner, RA.[2019]

Brief episodes of nonlethal myocardial ischemia can protect the heart by making it more resistant to future, more severe ischemic events, as shown by reduced infarct size in preconditioned hearts compared to controls.

Research is actively exploring the cellular mechanisms behind this protective effect, the broader implications of ischemic preconditioning beyond just infarct size, and its potential efficacy in clinical settings and various disease models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischemic preconditioning: exploring the paradox. Przyklenk, K., Kloner, RA.[2019]

Ischemic preconditioning (IPC) significantly improved heart function recovery after ischemia/reperfusion in isolated rat hearts, showing a continuous trend of recovery in myocardial function.

Pharmacological preconditioning with omeprazole also provided protective effects, particularly in systolic left ventricular pressure, but was less effective than IPC; however, it offers a viable alternative in clinical situations where IPC is not feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ischemia and omeprazole preconditioning on functional recovery of isolated rat heart. Jeremic, N., Petkovic, A., Srejovic, I., et al.[2018]

Ischemic preconditioning has shown promise in protecting the heart from damage during ischemic events, with evidence suggesting that the human myocardium can be preconditioned similarly to animal models, involving mechanisms like adenosine and protein kinase C.

Clinical studies indicate that preconditioning may improve outcomes in patients undergoing cardiac procedures, such as coronary artery bypass grafts, by reducing ATP depletion during ischemic episodes, although further research is needed to fully understand the mechanisms and develop safe pharmacological agents for preconditioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconditioning the human myocardium: recent advances and aspirations for the development of a new means of cardioprotection in clinical practice. Jenkins, DP., Steare, SE., Yellon, DM.[2020]

Ischemic preconditioning significantly reduces heart damage during prolonged ischemia-reperfusion by activating protective molecular pathways, including protein kinase C and mitochondrial K(+)ATP channels, which help improve heart function and reduce infarct size.

The IONA trial demonstrated that chronic use of nicorandil, a drug that mimics the effects of ischemic preconditioning, can improve cardiovascular outcomes in patients with coronary artery disease, highlighting the potential for pharmacological approaches to enhance heart protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How to use the paradigm of ischemic preconditioning to protect the heart?]. Argaud, L., Ovize, M.[2007]

Ischemic preconditioning (IP) significantly reduced intestinal injury caused by ischemia-reperfusion in a rat model, showing a lower histologic injury score compared to the IR group (2.00 vs 3.60).

IP also decreased harmful markers in intestinal tissue, such as malondialdehyde, myeloperoxidase, and TNF-α levels, while reducing the expression of adhesion molecules (ICAM-1 and VCAM-1) and inhibiting NF-κB activity, suggesting a protective mechanism against inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischemic preconditioning ameliorates intestinal injury induced by ischemia-reperfusion in rats. Ji, YY., Wang, ZD., Wang, SF., et al.[2022]

Ischemic preconditioning and postconditioning are effective strategies to protect the heart from damage caused by reperfusion injury after a heart attack, enhancing the heart's ability to withstand subsequent ischemic events.

However, the effectiveness of these cardioprotective strategies can be significantly influenced by comorbid conditions like diabetes and aging, which alter the heart's response to ischemia/reperfusion injury, highlighting the need for more targeted research in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction of cardiovascular risk factors with myocardial ischemia/reperfusion injury, preconditioning, and postconditioning. Ferdinandy, P., Schulz, R., Baxter, GF.[2022]

Chronic use of tefillin among Orthodox Jewish men is linked to improved vascular function and reduced inflammation, suggesting a remote ischemic preconditioning-like effect that may contribute to lower cardiovascular mortality.

Acute use of tefillin enhances artery diameter and blood flow in both tefillin users and non-users, indicating immediate benefits to vascular reactivity, although it does not significantly change inflammatory markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tefillin use induces remote ischemic preconditioning pathways in healthy men. Owens, AP., Robbins, N., Saum, K., et al.[2020]

Ischaemic preconditioning helps protect the heart from damage during procedures like percutaneous transluminal coronary angioplasty (PTCA) by reducing the severity of myocardial ischaemia during repeated balloon inflations, indicating a protective mechanism of the heart.

Several drugs, such as adenosine and nitroglycerin, can mimic the effects of preconditioning, suggesting that developing these preconditioning-mimetic drugs could enhance heart tolerance to angina and reduce the risk of serious heart issues like sudden cardiac death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischaemic preconditioning and outcomes after angioplasty: effects of drug therapy. Kato, T., Yoshimoto, N.[2018]

Ischemic preconditioning, which involves brief episodes of controlled ischemia, has been shown to protect the heart from more severe ischemic injury, suggesting that the heart has natural adaptive mechanisms to resist damage.

Research is ongoing to explore how these protective mechanisms can be induced in humans, with early studies indicating that preconditioning agents may improve heart protection during acute coronary syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Angina: who needs it? Cardioprotection in the preconditioning era. Dana, A., Yellon, DM.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6415735/

Tefillin use induces remote ischemic preconditioning ... Several large population studies have found that Orthodox Jewish men (who wear tefillin almost daily) have decreased cardiovascular mortality compared with non- ...

2. uc.edu uc.edu/news/articles/2023/01/university-of-cincinnati-research-shows-benefits-from-jewish-tradition.html

UC research shows benefits from Jewish tradition “What we found is that wearing tefillin in both male and females caused changes to the heart rate associated with lowering of the metabolism as ...

3. withpower.com withpower.com/trial/phase-effects-of-tefillin-use-on-markers-of-preconditioning-4-2024-8c262?condition=Heart+Disease&overallStatus=Recruiting&hasNoPlacebo=false

Preconditioning with Tefillin for Heart Disease The IONA trial demonstrated that chronic use of nicorandil, a drug that mimics the effects of ischemic preconditioning, can improve cardiovascular outcomes in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9847972/

Tefillin use induces preconditioning associated changes in ... Non-obstructive banding via tefillin use affects HRV dependent variables that have been associated with improved outcomes both before and after ...

5. researchgate.net researchgate.net/publication/367252101_Tefillin_use_induces_preconditioning_associated_changes_in_heart_rate_variability

(PDF) Tefillin use induces preconditioning associated ... This study evaluated the effects of NOB on heart rate variability (HRV) dependent factors that are known to be affected by various RIPC stimuli.

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0280216

Tefillin use induces preconditioning associated changes in ... This study evaluated the effects of NOB on heart rate variability (HRV) dependent factors that are known to be affected by various RIPC stimuli.

7. jpost.com jpost.com/health-and-wellness/article-729013

Expanded cardiovascular benefits shown when wearing ... “What we found is that wearing tefillin in both males and females caused changes to the heart rate associated with lowering of the metabolism ...