NCT03960073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

3.2 years

First QC Date

May 20, 2019

Last Update Submit

December 15, 2022

Conditions

Renal Insufficiency, ChronicHeart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    Maximal aerobic capacity (VO2peak) obtained from cardiopulmonary exercise testing

    Change over 4 weeks

Secondary Outcomes (3)

  • Reflected Pulse Wave Amplitude

    Change over 4 weeks

  • Forward Pulse Wave Amplitude

    Change over 4 weeks

  • Mitochondrial Respiration

    Change over 4 weeks

Study Arms (2)

MitoQ

EXPERIMENTAL

20mg daily oral dose of MitoQ

Dietary Supplement: MitoQ

Placebo

PLACEBO COMPARATOR

Oral TTP placebo

Dietary Supplement: Placebo

Interventions

MitoQDIETARY_SUPPLEMENT

4 week 20mg oral daily dose of Mito Q

MitoQ
PlaceboDIETARY_SUPPLEMENT

4 week oral daily dose of TTP placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • current cancer
  • current pregnancy
  • 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.
  • current antiretroviral medication use
  • absolute contraindications to exercise testing according to the American College of Sports Medicine guidelines
  • fluid overload
  • unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298-0256, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Danielle L Kirkman, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 22, 2019

Study Start

July 31, 2019

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

December 19, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)