External Body Pressure for Heart Failure

Overseen By David MacLeod, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Duke University

Disqualifiers: Myocardial infarction, Cardiomyopathy, Arrhythmia, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how External Body Pressure affects individuals with heart failure, focusing on exercise ability and heart function. It consists of two parts: one involves heart failure patients and healthy volunteers without invasive procedures, while the other takes a more in-depth approach with heart failure patients. The trial suits individuals over 30 with heart failure who have normal pumping ability and have been stable on heart medications for at least a month. As a Phase 1 and Phase 2 trial, the research aims to understand how the treatment works and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking heart failure research.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but it requires that your heart failure drug regimen has been stable for the past month. This suggests you may need to continue your current medications.

What prior data suggests that this external body pressure is safe for heart failure patients?

Research has shown that treatments applying pressure to the body have been tested in people with heart failure. One study with 15 patients who had severe long-term heart failure found that increased pressure on the lower body for a short time was linked to changes in heart function. This suggests the treatment can affect heart-related measures, but it doesn't directly address safety.

The trial under consideration is in the early stages, focusing on the treatment's safety and how well the body handles it. Detailed safety information is limited, but its testing in a clinical trial suggests some initial confidence in its safety. However, as this is an early study, detailed and long-term safety results are still forthcoming. ^{1 2 3 4 5}

Why are researchers excited about this trial?

External Body Pressure is unique because it offers a non-invasive approach to managing heart failure, which typically relies on medications like ACE inhibitors, beta-blockers, and diuretics. Researchers are excited about this technique because it could improve blood circulation without the need for drugs, potentially reducing side effects associated with long-term medication use. Additionally, this method may provide an alternative for patients who cannot tolerate conventional therapies, expanding treatment options for those with limited choices.

What evidence suggests that external body pressure is effective for heart failure?

Research shows that applying pressure to the outside of the body might help people with heart failure. In this trial, participants with heart failure will receive external body pressure treatment to assess its effects. A previous study with 15 patients who had severe long-term heart failure found that using positive pressure on the lower body significantly increased pressure in the heart's right atrium. This could mean better blood flow and heart function. The treatment changes the pressure around the body, which might help the heart pump blood more effectively. While more research is needed, these early results are promising for improving heart failure symptoms. ^{1 2 5 6 7}

Who Is on the Research Team?

Hemming

Principal Investigator

Duke

Are You a Good Fit for This Trial?

Adults over 30 with heart failure and preserved ejection fraction (HFpEF), able to speak English, on a stable heart medication for at least a month. They must have certain levels of wedge pressure indicating HF severity. Some will need an elective right heart catheterization. Excludes those with recent severe cardiac events, uncontrolled arrhythmias or blood pressure, significant lung disease, large aneurysms, electrolyte issues, pregnancy or inability to walk.

Inclusion Criteria

My heart failure medication has not changed in the last month.

I can walk with or without help from devices.

I have moderate heart condition symptoms.

Exclusion Criteria

I have inflammation of the heart muscle or its surrounding sac.

I have a severe but symptom-free narrowing of my heart's aortic valve.

Your body has imbalanced levels of important minerals like sodium and potassium.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo testing of positive and negative body pressure on exercise capacity, symptoms, blood volume distribution, and central cardiac hemodynamics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• External Body Pressure

Trial Overview The trial is examining how applying positive or negative body pressure affects exercise capacity and heart function in people with HFpEF. It includes two aims: non-invasive testing on healthy volunteers and patients; invasive testing measuring direct intracardiac pressures during scheduled catheterizations.

How Is the Trial Designed?

Group I: Experimental: Patients with heart failure (Aim 2) Experimental Treatment 1 Intervention

Group II: Experimental: Patients with heart failure (Aim 1) Experimental Treatment 1 Intervention

Group III: Control: Healthy Volunteers (Aim 1) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Natriuretic peptide (NP)-guided therapy significantly reduced overall mortality and heart failure (HF)-related hospital admissions in chronic heart failure patients, based on a systematic review of nine randomized clinical trials involving 1914 patients.

While NP-guided therapy showed benefits, the presence of clinical heterogeneity among the studies suggests that specific interventions should be carefully considered before making broad recommendations for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of natriuretic peptide-guided treatment of chronic heart failure. A meta-analysis. Gamiño-Arroyo, AE., Prado-Galbarro, FJ., García-Pérez, S., et al.[2019]

Lower body positive pressure (LBPP) treadmill activity significantly increases left ventricular ejection duration (LVED) in both heart failure (HF) patients and healthy individuals, indicating potential benefits for heart function during exercise.

However, the increase in LVED is less pronounced in HF patients compared to healthy individuals, suggesting that while LBPP is beneficial, its effects may vary based on the patient's heart condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Lower Body Positive Pressure on Left Ventricular Ejection Duration in Patients With Heart Failure. Avadhani, S., Ihsan, M., Nunez, A., et al.[2020]

In a study of 15 patients with severe chronic congestive heart failure, short-term increases in lower body positive pressure significantly raised right atrial and pulmonary artery pressures, indicating changes in right heart dynamics.

However, these changes did not translate into improvements in left heart function or overall cardiac work, suggesting that while right heart pressures can be increased, it does not lead to beneficial effects in patients with longstanding heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central haemodynamic changes during lower body positive pressure in patients with congestive cardiac failure. Bain, RJ., Tan, LB., Murray, RG., et al.[2019]

Heart failure (HF) patients often face significant symptoms and limitations, and while many drugs aim to reduce hospitalizations and mortality, few focus on improving quality of life and physical function.

The paper highlights the potential for using patient-reported outcomes, which capture patients' perceptions of their health status, as important endpoints in the development of new HF medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endpoints in Heart Failure Drug Development: History and Future. Fiuzat, M., Lowy, N., Stockbridge, N., et al.[2021]

Current guidelines do not specify a target blood pressure for patients with established left ventricular dysfunction, but this paper suggests a target range of 120-140/70-90 mm Hg for most patients, with lower pressures preferred if tolerated.

The review emphasizes the importance of considering various factors such as the type of heart failure, symptom severity, and individual patient characteristics when determining blood pressure goals in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating hypertension in patients with left ventricular dysfunction: hitting the fairway and avoiding the rough. Joffe, SW., Phillips, RA.[2021]

In a study of 12 patients with stable chronic cardiac failure (CCF) and 8 matched controls, total body water (TBW) and extracellular volume (ECV) were found to be similar between the two groups, indicating that excess body water is not a contributing factor to persistent symptoms in CCF patients.

The study utilized stable isotope dilution and bioelectrical impedance to measure TBW and ECV, revealing that patients with stable CCF had normal levels of these metrics, suggesting that their symptoms may be due to other underlying issues rather than fluid overload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body composition and energy expenditure of patients with chronic cardiac failure. Steele, IC., Young, IS., Stevenson, HP., et al.[2019]

The CHAMPION trial, involving 550 patients with class III heart failure, demonstrated that using an ambulatory pulmonary artery pressure monitoring system allowed for earlier interventions that significantly reduced heart failure hospitalizations compared to standard clinical assessments.

Patients in the active monitoring group received more frequent medication adjustments, particularly in diuretics and vasodilators, which helped lower cardiac filling pressures while preserving renal function, highlighting the efficacy of pressure-guided management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions Linked to Decreased Heart Failure Hospitalizations During Ambulatory Pulmonary Artery Pressure Monitoring. Costanzo, MR., Stevenson, LW., Adamson, PB., et al.[2022]

Patients managed in a heart failure clinic had a significantly lower rate of rehospitalization or death (42%) compared to those receiving usual care (65%) over a follow-up period of about 561 days, indicating better outcomes with specialized management.

Those in the heart failure clinic not only received more optimal pharmacological therapy but also reported a better quality of life, highlighting the benefits of targeted care in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure clinic in a community hospital improves outcome in heart failure patients. Lainscak, M., Keber, I.[2022]

In a study of 99 heart failure patients who received education and enhanced external counterpulsation (EECP) treatment within 90 days of hospital discharge, only 6.1% experienced unplanned readmissions, significantly lower than the predicted rate of 34%.

Patients also showed notable improvements in functional status, with an average increase of 52 meters in walking distance and a 100% increase in the Duke Activity Status Index, indicating enhanced overall health and reduced symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Enhanced External Counterpulsation on Heart Failure Rehospitalization in Patients With Ischemic Cardiomyopathy. Tecson, KM., Silver, MA., Brune, SD., et al.[2016]

Pressotherapy leads to increased right auricular and pulmonary pressures, especially in patients with heart failure, indicating a potential risk for this population.

Monitoring these pressure changes during pressotherapy is crucial for ensuring patient safety, particularly for those with existing heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effects of pressotherapy on cardiovascular hemodynamics]. Dereppe, H., Hoylaerts, M., Renard, M., et al.[2007]

Citations

1. withpower.com withpower.com/trial/phase-2-heart-failure-2-2023-563bf

External Body Pressure for Heart Failure · Info for Participants In a study of 15 patients with severe chronic congestive heart failure, short-term increases in lower body positive pressure significantly raised right atrial ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05764564

External Body Pressure in Heart Failure With Preserved ... The primary objective of the study is to test the impact of positive and negative body pressure on exercise capacity, symptoms, blood volume distribution and ...

3. nature.com nature.com/articles/s41598-024-63742-0

Effectiveness of remote pulmonary artery pressure ... PAP monitoring significantly reduced HF-related hospitalizations (RR 0.72 [95% CI 0.6–0.87], p = 0.0006) and HF events (RR 0.86 [95% CI 0.75– ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.119.006863

Lower Rates of Heart Failure and All-Cause ... PA pressure-guided therapy for HF was associated with lower PA pressures, lower rates of HFH and all-cause hospitalization, and low rates of adverse events.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10573601/

Heart Failure Remote Monitoring: A Review and ... In a postapproval study, CardioMEMS reduced HF hospitalizations at 12 months compared to the year before implantation (HR 0.43; 95% CI, 0.39– ...

6. nature.com nature.com/articles/s41597-021-00835-9

Electronic healthcare records and external outcome data ... It has been reported that the mortality ranges from 20% to 60% one year after hospitalization for acute HF, depending on comorbidities and ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230040B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Key secondary efficacy endpoints covered at 12-month follow-up include 1) the incidence of HF hospitalization and all-cause mortality at 12 months, 2) The.