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CoQ10 and D-ribose in Patients With Diastolic Heart Failure

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ClinicalTrials.gov Identifier: NCT03133793
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purpose of this study is to compare the clinical benefits of CoQ10 and D-ribose taken by patients who have diastolic heart failure, or heart failure with preserved ejection fraction (HFpEF).

Condition or disease Intervention/treatment Phase
Heart Failure, Diastolic Drug: CoQ10 Drug: D-Ribose Oral Powder Other: Placebo pills Other: Placebo powder Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Reducing Symptom Burden in Patients With Heart Failure With Preserved Ejection Fraction Using Ubiquinol and/or D-ribose
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Placebo Comparator: Placebo Only
Participants in this group will receive placebo pills and placebo powder.
Other: Placebo pills
Participants will take matched placebo pills that are 300mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.

Other: Placebo powder
Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.

Active Comparator: CoQ10 Only
Participants in this group will receive CoQ10 pills and placebo powder
Drug: CoQ10
Participants will take 300mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.

Other: Placebo powder
Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.

Active Comparator: D-ribose Only
Participants in this group will receive placebo pills and D-ribose oral powder.
Drug: D-Ribose Oral Powder
Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.

Other: Placebo pills
Participants will take matched placebo pills that are 300mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.

Experimental: CoQ10 + D-ribose
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
Drug: CoQ10
Participants will take 300mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.

Drug: D-Ribose Oral Powder
Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.




Primary Outcome Measures :
  1. Change in health status of patients with HFpEF [ Time Frame: Change from Baseline to Week 12 ]
    Patients' perceptions of their symptoms will be measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a self-administered questionnaire that measures patients' perceptions of five domains of their health status relevant to HFpEF. The KCCQ is a 24 item questionnaire. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.


Secondary Outcome Measures :
  1. Change in vigor [ Time Frame: Change from Baseline to Week 12 ]
    Change will be measured using the the Vigor subscale from the Profile of Mood States (POMS) questionnaire.The subscale has 8 questions. Scores for the subscale range from 0-32, in which higher scores reflect more vigor.

  2. Left ventricular diastolic function [ Time Frame: Change from Baseline to Week 12 ]
    Change will be measured using advanced echocardiographic imaging.

  3. Change in 6 minute walk test (6MWT) [ Time Frame: Change from Baseline to Week 12 ]
    The 6-minute walking test (6MWT) is a simple test. Test measures the total distance in meters a person can walk in 6 minutes.

  4. Change in venous blood B-type natriuretic peptide (BNP) levels [ Time Frame: Change from Baseline to Week 12 ]
    BNP concentration will be measured.

  5. Change in lactate/adenosine triphosphate (ATP) ratio [ Time Frame: Change from Baseline to Week 12 ]
    The lactate/ATP ratio will be measured for each participant.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed with HFpEF within a 6-month period
  • New York Heart Association (NYHA) Classification II-III HF
  • Have left ventricular ejection fraction (EF) ≥ 50% documented by an echocardiogram
  • Have a telephone or reliable phone contact
  • Have their own means of transportation to the study site

Exclusion Criteria:

  • Acute coronary syndrome in the past 12 weeks
  • Significant valvular heart disease
  • Severe cardiac fibrosis (galectin-3 level > 26 ng/ml)
  • Constrictive pericardium
  • Pulmonary fibrosis
  • Congenital heart disease
  • Hypertrophic or infiltrative cardiomyopathy
  • Heart transplant
  • Left ventricular assist device
  • Heart failure (HF) associated hospital admission or emergency room visit within past 30 days
  • Recent percutaneous coronary intervention
  • Significant renal and/or hepatic dysfunction
  • Severe cognitive impairment
  • Consumption of any CoQ10 (ubiquinol) or D-ribose supplements

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): NCT03133793


Contacts
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Contact: Faith Rahman (913) 588-4336 frahman2@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Janet Pierce, PhD University of Kansas Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03133793     History of Changes
Other Study ID Numbers: STUDY00140741
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
heart failure with preserved ejection fraction
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Coenzyme Q10
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs