Novel Approaches for Improving Vascular Function in Veterans With HFpEF

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
VA Office of Research and Development
Study ID
NCT06312748
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • L-Citrulline — DRUG
    100 mg tablet
  • Placebo for L-Citrulline — DRUG
    L-Citrulline-matched Placebo tablet
  • BH4 — DRUG
    10mg/kg
  • Placebo for BH4 — DRUG
    BH4-matched Placebo
  • Atorvastatin — DRUG
    10 mg tablet
  • Placebo for Atorvastatin — DRUG
    Atorvastatin-matched Placebo

Study Details

This project will evaluate the impact of L-Citrulline, tetrahydrobiopterin (BH4), and atorvastatin administration on physical capacity and vascular function in Veterans with heart failure with preserved ejection fraction (HFpEF).

Key Dates

Start date
May 19, 2021
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: L-Citrulline, Then Placebo
    Participants will receive a 90-day supply of L-Citrulline and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Placebo and perform baseline and follow-up assessments as above.
  • Experimental: BH4, Then Placebo
    Participants will receive a 90-day supply of BH4 and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Placebo and perform baseline and follow-up assessments as above.
  • Experimental: Atorvastatin, Then Placebo
    Participants will receive a 90-day supply of Atorvastatin and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Placebo and perform baseline and follow-up assessments as above.
  • Experimental: Placebo, Then L-Citrulline
    Participants will receive a 90-day supply of Placebo and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of L-Citrulline and perform baseline and follow-up assessments as above.
  • Experimental: Placebo, Then BH4
    Participants will receive a 90-day supply of Placebo and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of BH4 and perform baseline and follow-up assessments as above.
  • Experimental: Placebo, Then Atorvastatin
    Participants will receive a 90-day supply of Placebo and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Atorvastatin and perform baseline and follow-up assessments as above.

Primary Outcome Measure

Flow-mediated dilation (FMD) [ Time Frame: Baseline, Day 90 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake CityUtah84148-0001
David W Wray, PhD
[email protected]
801-582-1565
David W. Wray, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Salt Lake City, UT

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
VA Salt Lake City Health Care System, Salt Lake City, UT· Salt Lake City, UT

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