60 Participants Needed

Afferent Block for Heart Failure

TR
MR
Overseen ByMisti R Seppi, MBA BS AAS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This research in Veterans with heart failure with preserved ejection fraction (HFpEF) will provide new information on the mechanisms determining the patients' exercise intolerance and the efficacy of regular physical activity to improve this shortcoming by alleviating the patients' neurocirculatory abnormalities. Specifically, the investigators will focus on the role of nerves originating in working limb muscles in determining the patients' exercise intolerance and compromised fatigue resistance before and after a chronic exercise intervention. By focusing on a specific mechanism, this project will evaluate the validity of exercise as an alternative treatment strategy with the overall purpose of improving the quality of life of Veterans with HFpEF.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the Afferent Block treatment for heart failure differ from other treatments?

The Afferent Block treatment for heart failure is unique because it targets the Cardiac Sympathetic Afferent Reflex (CSAR), which is a positive-feedback mechanism that amplifies sympathetic activity. By blocking this reflex, the treatment aims to reduce the excessive sympathetic activity that contributes to heart failure, unlike traditional treatments like beta-blockers that primarily work by blocking beta-adrenergic receptors.12345

What data supports the effectiveness of the treatment Afferent block for heart failure?

Research on beta-blockers, which are similar in function to afferent block treatments, shows they can reduce mortality and improve heart function in heart failure patients. This suggests that treatments affecting the nervous system, like afferent block, might also be beneficial.46789

Who Is on the Research Team?

MA

Markus Amann, PhD

Principal Investigator

VA Salt Lake City Health Care System, Salt Lake City, UT

Are You a Good Fit for This Trial?

This trial is for Veterans with a type of heart failure where the heart muscle pumps out a normal amount of blood (HFpEF). It's not for those whose hearts can't pump enough blood (reduced ejection fraction). Participants will explore how exercise affects their condition.

Inclusion Criteria

My heart pumps well but is stiff.

Exclusion Criteria

My heart pumps less blood than normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a supervised 12-week knee-extension exercise training program to evaluate the effect of chronic exercise on muscle afferents and exercise tolerance

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the exercise training program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Afferent block
Trial Overview The study tests whether blocking certain nerves in limb muscles can improve exercise tolerance and fatigue resistance in patients. The focus is on regular physical activity as an alternative treatment to enhance quality of life.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Effect of cardiac rehabExperimental Treatment1 Intervention
Group II: Afferent effect on hemodynamicsExperimental Treatment1 Intervention
Group III: Afferent effect on fatigueExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

In a study involving 3991 patients with chronic heart failure, metoprolol CR/XL significantly reduced total mortality and hospitalizations compared to placebo, demonstrating a 19% reduction in all-cause hospitalizations and a 31% reduction in hospitalizations due to worsening heart failure.
Patients taking metoprolol CR/XL also showed improvements in their functional status and quality of life, as indicated by better NYHA class ratings and patient-reported outcomes, highlighting its efficacy in managing heart failure symptoms.
Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group.Hjalmarson, A., Goldstein, S., Fagerberg, B., et al.[2022]
In a study of 934 chronic heart failure patients, including 255 very old patients (≥80 years), the use of beta-blockers was associated with increased survival rates in both very old and younger patients, indicating their efficacy in improving outcomes in heart failure.
Renin-angiotensin system inhibitors also showed a survival benefit, particularly in younger patients, suggesting that neurohormonal modulation therapy is beneficial for older patients with chronic heart failure, despite their higher risk of mortality.
Prognostic impact of neurohormonal modulation in very old patients with chronic heart failure.Silva, JE., Melo, N., Ferreira, AI., et al.[2022]
Beta-adrenergic blocking agents significantly reduce overall mortality and cardiovascular mortality in heart failure patients, with a notable decrease in sudden death and pump failure mortality by 34% to 39%, based on a meta-analysis of 21 trials involving 5,849 patients.
Vasodilating beta-blockers are more effective than nonvasodilating agents in reducing overall mortality, particularly in patients without ischemic heart disease, showing a 45% reduction compared to 27% for nonvasodilating agents.
Beta-adrenergic blocking agents in heart failure: benefits of vasodilating and non-vasodilating agents according to patients' characteristics: a meta-analysis of clinical trials.Bonet, S., Agustí, A., Arnau, JM., et al.[2019]

Citations

Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group. [2022]
Prognostic impact of neurohormonal modulation in very old patients with chronic heart failure. [2022]
Beta-adrenergic blocking agents in heart failure: benefits of vasodilating and non-vasodilating agents according to patients' characteristics: a meta-analysis of clinical trials. [2019]
Beta-blocker therapy in heart failure: myths or realities. [2019]
[Adrenergic betablockers and heart failure]. [2013]
Heart Failure Due to High-Degree Atrioventricular Block: How Frequent Is It and What Is the Cause? [2021]
Muscle metaboreflex stimulates the cardiac sympathetic afferent reflex causing positive-feedback amplification of sympathetic activity: effect of heart failure. [2023]
Is beta-blockade useful in heart failure patients with atrial fibrillation? An analysis of data from two previously completed prospective trials. [2019]
[Beta-blockers and heart failure]. [2013]
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