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Chronic Kidney Disease and Heart Failure With Preserved Ejection Fraction: The Role of Mitochondrial Dysfunction

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ClinicalTrials.gov Identifier: NCT03960073
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Brief Summary:
The purpose of this study is to investigate the role of mitochondrial derived oxidative stress on exercise capacity and arterial hemodynamics in HFpEF patients with and without chronic kidney disease.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Heart Failure With Preserved Ejection Fraction Dietary Supplement: MitoQ Dietary Supplement: Placebo Not Applicable

Detailed Description:

Heart failure is a public health epidemic affecting 6.5 million Americans. Heart failure with preserved ejection fraction (HFpEF) accounts for a large burden of heart failure with the incidence and cost associated with the disease projected to double in the next 20 years. The pathophysiology of HFpEF has not yet been fully elucidated and no proven therapies for improving outcomes in HFpEF currently exist, posing major diagnostic and therapeutic challenges. The addition of chronic kidney disease (CKD) presents a complicated cardio renal syndrome that manifests a distinctly different phenotype and exacerbates the diagnostic and therapeutic challenges of HFpEF. This study aims to address the urgent need to establish treatment targets and therapies by investigating potential underlying biological contributors to HFpEF and its symptoms.

Mitochondrial dysfunction is consistently reported in CKD and heart failure. Mitochondrial dysfunction has been implicated in cardiac, skeletal muscle and vascular dysfunction and is therefore an attractive target for a 'whole systems' therapeutic approach that would encompass exercise intolerance and abnormal blood vessel hemodynamics. A known contributor to and subsequent cyclical result of mitochondrial dysfunction is an abnormally heightened production of mitochondria derived oxidative stress. This study will address the role of mitochondria derived oxidative stress in mitochondrial dysfunction, exercise intolerance and large blood vessel hemodynamics HFpEF patients with and without CKD.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Chronic Kidney Disease and Heart Failure With Preserved Ejection Fraction: The Role of Mitochondrial Dysfunction
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MitoQ
20mg daily oral dose of MitoQ
 Dietary Supplement: MitoQ
4 week 20mg oral daily dose of Mito Q
Placebo Comparator: Placebo
Oral TTP placebo
 Dietary Supplement: Placebo
4 week oral daily dose of TTP placebo


Outcome Measures
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Primary Outcome Measures :
  1. Exercise Capacity [ Time Frame: Change over 4 weeks ]
    Maximal aerobic capacity (VO2peak) obtained from cardiopulmonary exercise testing


Secondary Outcome Measures :
  1. Reflected Pulse Wave Amplitude [ Time Frame: Change over 4 weeks ]
    Late systolic pulsatile load on the left ventricle represented by reflected pulse wave amplitude; assessed by echocardiography combined with applanation tonometry.

  2. Forward Pulse Wave Amplitude [ Time Frame: Change over 4 weeks ]
    Central hemodynamic assessment of the forward pulse wave amplitude assessed by echocardiography combined with applanation tonometry.

  3. Mitochondrial Respiration [ Time Frame: Change over 4 weeks ]
    High resolution mitochondrial respirometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. above the age of 18 years
  2. a clinical diagnosis of stable Stage C Heart Failure with NYHA Class II-III symptoms
  3. a left ventricular ejection fraction >50%

Exclusion Criteria:

  1. current cancer
  2. current pregnancy
  3. current antioxidant supplement use and unwilling to have a 7-day antioxidant washout period before the beginning the trial and to continue antioxidant disuse throughout the trial.
  4. current antiretroviral medication use
  5. absolute contraindications to exercise testing according to the American College of Sports Medicine guidelines
  6. fluid overload
  7. unable to provide informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960073


Contacts
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Contact: Danielle L Kirkman, PhD 8048272386 dlkirkman@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298-0256
Contact: Danielle L Kirkman, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Danielle L Kirkman, PhD Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03960073    
Other Study ID Numbers: HM20015440
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Heart Failure
 Heart Diseases
Cardiovascular Diseases
Urologic Diseases