- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06256276
Nutritional Therapy for Autonomic Dysfunction in Elderly Heart Failure Patients
Study Overview
Status
Conditions
Detailed Description
Heart Failure is defined as "a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill or eject blood." The New York Heart Association classifies heart failure four functional classes: NYHA 1-4, with Class 1 as minimal and Class 4 as the most advanced stage.
As a clinical syndrome, HF can be associated with significant limitations in functional capacity which can be very debilitating in the elderly population. It is a major cause of morbidity and mortality and is the leading cause of hospitalization among older individuals in the United States (1-15), particularly among those aged ≥65 years (16, 18). Nearly 1 million hospitalizations for HF occur each year with rates of hospitalization continuing to rise. Prevalence of heart failure was estimated to be more than 5.8 million in the United States and HF was singled out as an emerging epidemic (17).
Heart failure is associated with autonomic and endothelial dysfunction. Recent studies suggest that patients with HF maybe more prone to having impaired vasomotor and autonomic response to stress (19-29). A reduced ability to increase blood flow or heart rate appropriately in response to demand could limit the functional capacity of these subjects and would contribute to orthostasis (drop in blood pressure on standing). Another factor contributing to orthostasis in these individuals is poor muscle tone in the lower extremities reducing venous flow.
Endothelial dysfunction in HF on the other hand is attributed to decreased production of NO and increased oxidative stress due to neurohumoral activation, release of inflammatory messengers from the myocardium, altered local shear force and resultant atherogenesis (30, 31). The endothelial dysfunction itself causes an increase in the production of cytokines, uncoupling of eNOS and further increases the oxidative stress (32-35). The endothelium helps in regulating the vascular tone by balancing the production of vasodilators and vasoconstrictors in response to various stimuli (36) and its dysfunction would also impair baroreceptor function which in turn would affect cardiac autonomic activity and blood flow.
In our research we hope to improve both autonomic and endothelial function by supplementing protein and carnitine in diet. Studies have shown that when protein is metabolized to the amino acids L-arginine and citrulline, there is increased synthesis of NO (37). L-arginine, a semi-essential basic amino acid, is a precursor in the formation of nitric oxide by the enzyme nitric oxide synthase and directly increases the formation of NO (38). The administration of arginine and/or citrulline in patients in HF has been reported to improve endothelial function. Systolic and diastolic arterial pressures as well as pulmonary arterial systolic pressure have been shown to decrease significantly after administration of arginine or citrulline administration, which in turn improves right ventricular diastolic diameter (37, 39). One clinical study reported improvement in pulmonary artery pressure and right ventricular ejection fraction after two months of oral supplementation with L-arginine or citrulline in patients with HF and right ventricular dysfunction (39). It is hoped that protein supplementation will improve autonomic function by having a positive impact on physiological and biochemical parameters, including nitric oxide synthesis which is expect will improve baroreceptor blood flow, autonomic BP and HR in response to tilt.
Carnitine supplementation of 1g/d for 12 wk in hemodialysis patients significantly reduced systemic inflammation, as reflected by decreases in CRP, IL-1β, and IL-6 (40). In obesity, the mitochondrial abnormalities of reduced fatty acid oxidation, incomplete β-oxidation, and impaired substrate switching from fatty acid to pyruvate were reversed after 8wks of oral supplementation with the same dosage of carnitine (41). It is anticipated the same beneficial effects of carnitine in individuals with HF.
The purpose of this study is to evaluate the effects of 16 weeks of protein supplementation on measures of autonomic regulation of blood pressure and heart rate, as well as physical strength and function in elderly subjects with mild to moderate heart failure (NYHA 1, 2, or 3). Each participant will be randomized to one of two groups (whey protein + L-carnitine or placebos). Study endpoints will be measured at baseline and after 4 months of treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mild to moderate heart failure (NYHA I, II, or III symptomology) as confirmed by study physician
Exclusion Criteria:
- Moderately-severe dementia (MoCA score)
- Active inflammatory bowel disease
- Active cancer or chemotherapy in the past year
- Self-reported allergy to whey protein
- Documented insulin-dependent diabetes mellitus, or uncontrolled diabetes with hemoglobin A1C >8.5% (collected from medical record)
- >50mg doses of metoprolol or atenolol daily or more than 12.5mg twice daily of carvedilol
- History of renal failure stage IV or V
- History of severe orthostasis (>20mm Hg drop in systolic pressure)
- History of high grade second degree heart block
- History of arrhythmias (atrial or ventricular, tachy or brady)
- Other criteria as determined by the study physician
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whey protein powder and L-carnitine capsules
Subjects will daily consume whey protein powder to supplement normal daily protein intake up to 1.2g protein/kg body weight per day (1 or 2 scoops powder), as well as 2 capsules (1 gram) L-carnitine for 16 weeks.
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Dietary supplement intervention for 16 weeks
Other Names:
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Placebo Comparator: Maltodextrin placebo powder and Psyllium Husk capsules
Subjects will daily consume maltodextrin powder as if to supplement normal daily protein intake up to 1.2g protein/kg body weight per day (1 or 2 scoops powder), as well as 2 capsules (1 gram) psyllium husk for 16 weeks.
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Maltodextrin placebo powder and Psyllium Husk capsules
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular assessment of blood pressure
Time Frame: Change from baseline to 16 weeks
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Measuring orthostatic blood pressure
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Change from baseline to 16 weeks
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Cardiovascular assessment
Time Frame: Change from baseline to 16 weeks
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Measuring heart rate before and after intervention
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Change from baseline to 16 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gohar Azhar, M.D., University of Arkansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202617
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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