Other Clinical Trial - Neuromodulation to Treat Patients With Heart

Status Completed

Clinical Trial Summary

Heart failure with preserved ejection fraction (HFpEF) is a leading cause of mortality in the elderly. Outcomes of patients with HFpEF are poor and so far, no treatment has been shown to decrease morbidity or mortality. Recent animal and human studies suggest that a systemic proinflammatory state, produced by comorbidities, including aging, plays a central role in the development of HFpEF, supporting the notion that attenuating the proinflammatory state is an attractive therapeutic target for HFpEF. We have previously shown that low-level transcutaneous electrical stimulation of the vagus nerve (tVNS) suppresses inflammation in patients with atrial fibrillation. The overall objective of this proposal is to examine the effects of tVNS on diastolic dysfunction, exercise capacity and inflammation in patients with HFpEF. Our specific aims include: 1. To examine the effect of intermittent (1 hour daily for 3 months) tVNS on diastolic dysfunction and exercise capacity, relative to sham stimulation, in patients with HFpEF and 2. To examine the effect of intermittent (1 hour daily for 3 months) LLTS on inflammatory cytokines relative to sham stimulation, in patients with HFpEF. The proposed proof-of-concept studies will provide the basis for the design of further human studies using LLTS among populations with HFpEF. In light of the increasing number of elderly patients with HFpEF and the poor success of the currently available treatment options, an alternative and novel approach such as tVNS has the potential to impact clinical practice and improve health outcomes among a large number of patients. It is anticipated that these investigations will contribute to the broader understanding of the role of inflammation in the pathogenesis of HFpEF and how its inhibition can be used to provide therapeutic effects. Moreover, it is anticipated that a better understanding of how modulation of inflammation affects one of the hallmarks of HFpEF, diastolic dysfunction, will lead to the development of novel pharmacological and non-pharmacological approaches to treat this disease.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Heart Failure
Heart Failure With Normal Ejection Fraction

Clinical Trial Details

NCT number	NCT03327649
Study type	Interventional
Source	University of Oklahoma
Contact
Status	Completed
Phase	N/A
Start date	December 12, 2017
Completion date	September 30, 2021

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See also
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Completed	`NCT02638961` - Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of HFpEF	N/A
Completed	`NCT03871803` - β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity (Preserve-HR)	Phase 4
Completed	`NCT03672591` - Renal Hemodynamics in Patients With HFpEF
Recruiting	`NCT03620526` - Inhaled Iloprost and Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction	Phase 4
Active, not recruiting	`NCT03624010` - Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients	Phase 2
Completed	`NCT03541603` - Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF	Phase 2
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Completed	`NCT02744339` - Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction	Phase 2
Completed	`NCT03387813` - Hemodynamic-GUIDEd Management of Heart Failure	N/A
Completed	`NCT03186833` - The Heart Failure With Preserved Ejection Fraction (HFpEF) Pathophysiology Study.
Completed	`NCT03289481` - Treatment of HFpEF With Nitrate Supplement	Early Phase 1
Terminated	`NCT03195660` - Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study	N/A
Completed	`NCT03226652` - Heart Function in Patients Assessed for Sleep Apnoea
Completed	`NCT03966755` - Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF	N/A
Not yet recruiting	`NCT04282850` - Ablation Versus Medical Management of Atrial Fibrillation in HFpEF	N/A
Recruiting	`NCT03184311` - High-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Neuromodulation to Treat Patients With Heart Failure With Preserved Ejection Fraction

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms