CoQ10 and D-ribose in Patients With Diastolic Heart Failure

NCT03133793 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY001407415R01AG054486-02
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure, Diastolic

Keywords

heart failure with preserved ejection fraction

Outcome Measures

Primary Outcomes (1)

• Change in Health Status of Patients With HFpEF

  Patients' perceptions of their symptoms were 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. All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.

  Change from Baseline to Week 12

Secondary Outcomes (7)

• Change in Vigor

  Change from Baseline to Week 12

• Change in Ejection Fraction (EF)

  Change from Baseline to Week 12

• Change in Septal E/e'

  Change from Baseline to Week 12

• Change in 6 Minute Walk Test (6MWT)

  Change from Baseline to Week 12

• Change in Venous Blood B-type Natriuretic Peptide (BNP) Levels

  Change from Baseline to Week 12

Study Arms (4)

Placebo Only

PLACEBO COMPARATOR

Participants in this group will receive placebo pills and placebo powder.

Other: Placebo pills; Other: Placebo powder

CoQ10 Only

ACTIVE COMPARATOR

Participants in this group will receive CoQ10 pills and placebo powder

Drug: CoQ10; Other: Placebo powder

D-ribose Only

ACTIVE COMPARATOR

Participants in this group will receive placebo pills and D-ribose oral powder.

Drug: D-Ribose Oral Powder; Other: Placebo pills

CoQ10 + D-ribose

EXPERIMENTAL

Participants in this group will receive CoQ10 pills and D-ribose oral powder.

Drug: CoQ10; Drug: D-Ribose Oral Powder

Interventions

CoQ10 DRUG

Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.

CoQ10 + D-ribose; CoQ10 Only

D-Ribose Oral Powder DRUG

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

CoQ10 + D-ribose; D-ribose Only

Placebo pills OTHER

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

D-ribose Only; Placebo Only

Placebo powder OTHER

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

CoQ10 Only; Placebo Only

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

• Pierce JD, Shen Q, Mahoney DE, Rahman F, Krueger KJ, Diaz FJ, Clark L, Smith C, Vacek J, Hiebert JB. Effects of Ubiquinol and/or D-ribose in Patients With Heart Failure With Preserved Ejection Fraction. Am J Cardiol. 2022 Aug 1;176:79-88. doi: 10.1016/j.amjcard.2022.04.031. Epub 2022 May 27.

  PMID: 35644694 DERIVED

• Pierce JD, Mahoney DE, Hiebert JB, Thimmesch AR, Diaz FJ, Smith C, Shen Q, Mudaranthakam DP, Clancy RL. Study protocol, randomized controlled trial: reducing symptom burden in patients with heart failure with preserved ejection fraction using ubiquinol and/or D-ribose. BMC Cardiovasc Disord. 2018 Apr 2;18(1):57. doi: 10.1186/s12872-018-0796-2.

  PMID: 29606104 DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

One limitation of this clinical trial was the occurrence of the COVID-19 pandemic during data collection. Several of the patients decided not to participate leading to a small number of subjects in the study.

Results Point of Contact

• Title: Dr. Mario Medina, Director of Sponsored Programs Administration
• Organization: Sponsored Programs Adminstration (SPA)

mmedina3@kumc.edu

913-588-5724

Study Officials

• Janet Pierce, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 28, 2017
• Study Start: February 5, 2018
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: March 18, 2022
• Results First Posted: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)