Ketone + Hawthorn Supplements for Heart Failure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must be taking: Guideline therapy

Must not be taking: Insulin, Steroids

Disqualifiers: Type I DM, Atrial fibrillation, Valvular disease, others

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if ketone or hawthorn supplements can improve heart health in people with congestive heart failure. Participants will be divided into three groups: one taking a ketone supplement, another taking a hawthorn supplement, and the last taking a placebo (a look-alike pill with no active ingredients). Individuals with congestive heart failure who have experienced symptoms like fatigue or shortness of breath during regular activities may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new heart health solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on stable heart failure medication for at least a month before joining, so you might need to continue your current treatment.

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

A previous study showed that ketone supplements positively affect heart health, especially in people with stable heart failure. These supplements are generally safe and easy for healthy adults to use. However, people with heart failure should be cautious with certain ketone supplements containing salt, as they may need to monitor their salt intake.

Research on hawthorn supplements indicates they are usually well-tolerated, with dizziness being the most common side effect. Some reports suggest that hawthorn might sometimes worsen heart failure, though the reasons remain unclear. Hawthorn might also interact with certain heart medications, so it's important to consider this before using it.

Overall, both ketone and hawthorn supplements have shown potential benefits for heart health, but they also come with some risks. Consulting a healthcare provider is important, especially for those with a heart condition or those taking medication. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for heart failure, which often includes medications like ACE inhibitors, beta-blockers, and diuretics, the treatments in this trial explore natural compounds. The ketone supplementation works by providing an alternative energy source for heart cells, potentially improving energy efficiency and function. Hawthorn extract, on the other hand, is known for its antioxidant properties and may improve blood flow and heart muscle performance. Researchers are excited about these treatments because they offer a novel, potentially less invasive approach to managing heart failure symptoms by leveraging natural compounds that could complement or enhance existing therapies.

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

This trial will compare the effects of ketone supplementation and hawthorn extract on heart failure. Studies have shown that ketone supplements can positively impact heart health. For example, patients with stable heart failure experienced better heart function after taking ketone ester for 14 days. These supplements may help by improving the heart's pumping efficiency and reducing inflammation.

Research also suggests that hawthorn extract might be beneficial for heart failure. A review of several studies found that hawthorn could safely improve heart function, easing symptoms like shortness of breath and tiredness. This extract may enhance the heart's ability to work harder and improve overall heart health. ^{2 3 6 7 8}

Who Is on the Research Team?

Andrew B Newberg, MD

Principal Investigator

Thomas Jefferson University, Marcus Institute

Are You a Good Fit for This Trial?

This trial is for individuals with congestive heart failure who are patients at Jefferson Health in Philadelphia. Participants will be randomly assigned to one of three groups: one taking a ketone supplement, another taking hawthorn extract, and the third receiving a placebo.

Inclusion Criteria

I am 18 years old or older.

My current medication doses have been stable for at least 1 month.

I have heart failure and am classified as having moderate or moderately severe symptoms.

Exclusion Criteria

I have chest pain due to a significant blockage in my heart's arteries.

I have not had a heart procedure in the last 2 months.

Patients with Type I DM

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ketone supplement, hawthorn extract, or placebo for approximately 8 weeks

8 weeks

Regular visits for supplement administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Evaluations at weeks 10 to 12

What Are the Treatments Tested in This Trial?

Interventions

• Hawthorn supplement
• Ketones

Trial Overview The study aims to determine if ketone or hawthorn supplements can improve heart health in congestive heart failure patients. It's a single-blind study where participants won't know which treatment they receive but the doctor will. The supplementation period lasts about 8 weeks.

How Is the Trial Designed?

Group I: Ketone supplementation Experimental Treatment 1 Intervention

commercially available nutritional ketone monoester

Group II: Hawthorn extract Experimental Treatment 1 Intervention

commercially available Hawthorn extract

Group III: Placebo Placebo Group 1 Intervention

Placebo supplement

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2754502/

Hawthorn Extract Randomized Blinded Chronic Heart ... A meta-analyses of clinical trials concluded that hawthorn may be a safe and effective treatment for chronic heart failure. Although most previous trials of ...

2. nature.com nature.com/articles/s41598-024-74325-4

Real world effectiveness of Hawthorn special extract WS ... Hawthorn special extract WS 1442 has beneficial effects on the cardiovascular system. Experimental studies have shown an antiarrhythmic effect of the substance.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002934303001311

Hawthorn extract for treating chronic heart failure Our results suggest that, compared with placebo, hawthorn extract increases the maximal workload in patients with chronic heart failure.

4. aafp.org aafp.org/pubs/afp/issues/2010/0215/p465.html

Health Effects of Hawthorn Other studies of hawthorn in patients with heart failure have revealed improvement in clinical symptoms, pressure–heart rate product, left ...

5. amjmed.com amjmed.com/article/S0002-9343(03)00131-1/abstract

Hawthorn extract for treating chronic heart failure Symptoms such as dyspnea and fatigue improved significantly with hawthorn treatment as compared with placebo. Reported adverse events were infrequent, mild, and ...

6. nccih.nih.gov nccih.nih.gov/health/hawthorn

Hawthorn: Usefulness and Safety | NCCIH One study indicated that a specific preparation of hawthorn (C. oxycantha) may have caused early risk of heart failure progression in patients. It's unclear why ...

7. webmd.com webmd.com/vitamins/ai/ingredientmono-527/hawthorn

Hawthorn: Uses, Side Effects and More When taken by mouth: Hawthorn is possibly safe when used in doses up to 1800 mg daily for up to 16 weeks. There isn't enough reliable information to know if ...

8. ceemjournal.org ceemjournal.org/m/journal/view.php?number=398

a case report Acute intoxication with hawthorn root extract in an adult patient resulted in arrhythmia and subsequent death. INTRODUCTION. The use of extracts ...