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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 : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE July 31, 2019
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
Exercise Capacity [ Time Frame: Change over 4 weeks ]
Maximal aerobic capacity (VO2peak) obtained from cardiopulmonary exercise testing
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03960073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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.
  • 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.
  • Mitochondrial Respiration [ Time Frame: Change over 4 weeks ]
    High resolution mitochondrial respirometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chronic Kidney Disease and Heart Failure With Preserved Ejection Fraction: The Role of Mitochondrial Dysfunction
Official Title  ICMJE Chronic Kidney Disease and Heart Failure With Preserved Ejection Fraction: The Role of Mitochondrial Dysfunction
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Renal Insufficiency, Chronic
  • Heart Failure With Preserved Ejection Fraction
Intervention  ICMJE
  • Dietary Supplement: MitoQ
    4 week 20mg oral daily dose of Mito Q
  • Dietary Supplement: Placebo
    4 week oral daily dose of TTP placebo
Study Arms  ICMJE
  • Experimental: MitoQ
    20mg daily oral dose of MitoQ
    Intervention: Dietary Supplement: MitoQ
  • Placebo Comparator: Placebo
    Oral TTP placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 liver disease
  3. current pregnancy
  4. clinically diagnosed lung disease
  5. 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.
  6. current antiretroviral medication use
  7. absolute contraindications to exercise testing according to the American College of Sports Medicine guidelines
  8. fluid overload
  9. unable to provide informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Danielle L Kirkman, PhD 8048272386 dlkirkman@vcu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960073
Other Study ID Numbers  ICMJE HM20015440
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Danielle L Kirkman, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP