Forced Desynchrony for High Blood Pressure

Recruiting in Palo Alto (17 mi)

Overseen by Steven A Shea, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Oregon Health and Science University

Must not be taking: Antihypertensives, Caffeine, Nicotine, Alcohol

Disqualifiers: Severe renal disease, Sleep apnea, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will be the first to distinguish the relative contributions of sleep, circadian and behavioral mechanisms to the non-dipping BP profile in Black adults and will lay the groundwork for optimizing therapies dependent on mechanisms, such as targeting sleep, targeting circadian rhythmicity, or targeting behaviors, and raising the possibility that ideal therapy for hypertension (HTN) may differ by race. This research will ultimately help to improve health and survival in black populations with HTN.

Will I have to stop taking my current medications?

Yes, you must be free of all prescription and non-prescription drugs, including caffeine, nicotine, alcohol, and herbal medications, to participate in this trial.

Is Forced Desynchrony safe for humans?

The research articles provided do not contain specific safety data for Forced Desynchrony in humans. They focus on cardiac resynchronization therapy, which is a different treatment, and its safety has been well-documented in heart failure patients. ^{1 2 3 4 5}

How does the treatment in the Forced Desynchrony for High Blood Pressure trial differ from other treatments for high blood pressure?

The treatment in the Forced Desynchrony for High Blood Pressure trial is unique because it involves altering the timing of heart contractions to improve blood flow, unlike traditional high blood pressure treatments that typically focus on medication to relax blood vessels or reduce fluid volume. This approach is similar to cardiac resynchronization therapy used in heart failure, which aims to synchronize heart contractions for better efficiency. ^{6 7 8 9 10}

Research Team

Steven A Shea, PhD

Principal Investigator

Ore

Eligibility Criteria

This trial is for self-identified Black or White adults who are either 'normotensive' with blood pressure under 140/90 mmHg, or have stage 1 hypertension with systolic BP between 140 and 160 mmHg or diastolic BP between 90 and 100 mmHg. Participants should not be on any medication (including caffeine and alcohol), must not smoke, do night shifts, or have traveled across time zones recently. They also shouldn't have severe health issues like renal disease.

Inclusion Criteria

Self-identified Black or White

I am not taking any prescription, over-the-counter drugs, or substances like caffeine or alcohol.

Your blood pressure should be normal or slightly high, but not too high.

Exclusion Criteria

You have smoked in the past year.

I have been diagnosed with moderate to severe sleep apnea.

I have no severe health issues except possibly mild high blood pressure or serious kidney disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Forced Desynchrony Protocol

Participants undergo a forced desynchrony protocol to study sleep, circadian, and behavioral mechanisms affecting blood pressure

7 days

7-day lab stay

Ambulatory Monitoring

Participants undergo 24-hour ambulatory blood pressure monitoring to estimate blood pressure dipping status

2 days

2-day ambulatory period

Follow-up

Participants are monitored for safety and effectiveness after the main protocol

4 weeks

Treatment Details

Interventions

• Forced Desynchrony (Behavioral Intervention)

Trial Overview The study investigates how sleep, circadian rhythms, and behaviors contribute to non-dipping blood pressure profiles in Black adults compared to White adults. It aims to understand if race influences the best treatment for hypertension by examining these different factors.

Participant Groups

Group I: Forced Desynchrony Experimental Treatment 1 Intervention

All participants will undergo a forced desynchrony protocol.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

John Hunter

Oregon Health and Science University

Chief Medical Officer since 2024

MD, specific details unavailable

Ann Madden Rice

Oregon Health and Science University

Chief Executive Officer

FACHE certification, extensive leadership experience in academic health centers

Findings from Research

In a study of 3253 patients with CRT-D devices followed for a median of 18 months, device-related events were more common than in single- or dual-chamber defibrillators, with 50% of patients requiring surgical revision for battery depletion within four years.

Despite the higher frequency of complications, such as infections and lead dislodgements, these device-related events did not lead to worse clinical outcomes, as the risk of death was similar between patients with and without surgical revisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term complications related to biventricular defibrillator implantation: rate of surgical revisions and impact on survival: insights from the Italian Clinical Service Database. Landolina, M., Gasparini, M., Lunati, M., et al.[2022]

Cardiac resynchronization therapy (CRT) is an effective treatment for patients with heart failure and left ventricular dysynchrony, supported by evidence from over 4000 randomized controlled trials and additional observational studies.

CRT significantly improves heart function, exercise tolerance, quality of life, and reduces hospitalization and mortality rates in patients classified as New York Heart Association class III and IV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac resynchronization therapy. Abraham, WT.[2007]

In a study of 51 chronically right ventricular-paced patients with severe heart failure, 15 patients (29%) showed significant improvement in left ventricular function after upgrading to cardiac resynchronization therapy (CRT-D), indicating that CRT can effectively reverse heart failure symptoms in certain patients.

Key predictors of positive response to CRT included smaller left ventricular dimensions and a shorter duration of cardiomyopathy, with hyperresponders experiencing excellent long-term survival, as none required transplants or mechanical support during a follow-up period of about 42 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting hyperresponse among pacemaker-dependent nonischemic cardiomyopathy patients upgraded to cardiac resynchronization. Adelstein, E., Schwartzman, D., Gorcsan, J., et al.[2022]

Cardiac resynchronization therapy (CRT) has emerged as a highly effective treatment for improving cardiac efficiency in patients with heart failure by addressing cardiac dyssynchrony, a condition that has been recognized for over 50 years.

Recent advancements in CRT technology and large-scale clinical trials have led to its widespread adoption, highlighting the importance of proper patient selection and ongoing monitoring for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac resynchronization therapy: redefining the role of device therapy in heart failure. Viswanathan, K., Ghosh, J., Kaye, GC., et al.[2010]

A novel heart failure model using rapid pacing combined with forced ventricular desynchronization in 20 pigs resulted in more severe hemodynamic impairment compared to traditional models, indicating its effectiveness for studying heart failure.

Group B, which experienced desynchronized pacing, showed significantly worse cardiac function and increased heart-to-body weight ratio, along with greater histological changes like cell enlargement and fibrosis, highlighting the model's ability to mimic advanced heart failure conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Desynchronization: a novel model to induce heart failure. Möllmann, H., Voss, S., Nef, HM., et al.[2009]

Cardiac resynchronization therapy, particularly biventricular pacing, is highly effective for patients with congestive heart failure and severe left ventricular dysfunction, improving heart function by coordinating contractions without increasing heart muscle strength.

Atrial resynchronization may help prevent atrial fibrillation in certain patients, but its overall antiarrhythmic benefits are less clear compared to the well-established advantages of ventricular resynchronization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is cardiac resynchronization therapy? Barold, SS.[2019]

Patients with heart failure and left ventricular dyssynchrony show significantly altered hemodynamic forces compared to healthy individuals, indicating a potential new way to assess cardiac function using 4-D flow MRI.

The study found that diastolic force patterns can effectively distinguish between healthy and diseased hearts, suggesting that analyzing these forces could improve risk stratification and guide cardiac resynchronization therapy (CRT) decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic forces using four-dimensional flow MRI: an independent biomarker of cardiac function in heart failure with left ventricular dyssynchrony? Arvidsson, PM., Töger, J., Pedrizzetti, G., et al.[2020]

In a study of 30 heart failure patients, it was found that any form of ventricular pacing can enhance heart contractile function if it reduces baseline biventricular mechanical asynchrony, measured by the NPP loop area.

Biventricular pacing was particularly effective, showing a 16% greater increase in contractile function compared to right ventricular pacing, but improvements depend on the level of baseline asynchrony, indicating that biventricular resynchronization is just one of several mechanisms that can lead to better heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biventricular mechanical asynchrony predicts hemodynamic effect of uni- and biventricular pacing. Yu, Y., Kramer, A., Spinelli, J., et al.[2020]

Cardiac re-synchronization therapy is increasingly recognized as an effective treatment for heart failure patients experiencing de-synchronized heart contractions, particularly due to left bundle branch block.

The study emphasizes the use of conventional echocardiography to assess different types of dyssynchrony (atrioventricular, interventricular, and intraventricular), allowing for a better understanding of the mechanical issues in the heart without relying on advanced imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Is standard-echocardiography sufficient for identification of responders?]. Neuss, M., Flach, P., Ali, T., et al.[2018]

Biventricular pacing significantly improves functional capacity in patients with severe heart failure, as evidenced by a reduction in NYHA functional class from IV to II after one year.

The therapy also enhances left ventricular function, demonstrated by increased ejection fraction and reduced mitral regurgitation, with sustained improvements in exercise capacity over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biventricular pacing in end-stage heart failure improves functional capacity and left ventricular function. Bakker, PF., Meijburg, HW., de Vries, JW., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term complications related to biventricular defibrillator implantation: rate of surgical revisions and impact on survival: insights from the Italian Clinical Service Database. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Cardiac resynchronization therapy. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Predicting hyperresponse among pacemaker-dependent nonischemic cardiomyopathy patients upgraded to cardiac resynchronization. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Cardiac resynchronization therapy: redefining the role of device therapy in heart failure. [2010]

5. Germany pubmed.ncbi.nlm.nih.gov

Desynchronization: a novel model to induce heart failure. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

What is cardiac resynchronization therapy? [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Hemodynamic forces using four-dimensional flow MRI: an independent biomarker of cardiac function in heart failure with left ventricular dyssynchrony? [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Biventricular mechanical asynchrony predicts hemodynamic effect of uni- and biventricular pacing. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

[Is standard-echocardiography sufficient for identification of responders?]. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Biventricular pacing in end-stage heart failure improves functional capacity and left ventricular function. [2019]