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Novel Approaches for Improving Vascular Function in Veterans With HFpEF

ConditionsHeart Failure With Preserved Ejection FractionInflammation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older and able to give written informed consent.

New York Heart Association (NYHA) functional class I, II, or III.

Left Ventricular Ejection Fraction (LVEF) > 50%.

Plasma Brain Natriuretic Peptide (BNP) equal to or greater than 150 pg/mL or NT-proBNP equal to or greater than 600 pg/mL at Visit 1, or a BNP equal to or great than 100 pg/mL (or NT-proBNP equal to or greater than 400 pg/mL) and a hospitalization for heart failure within the last 12 months.

Disqualifiers

History of hypersensitivity or allergy to any lipophilic statin.

Prior EF <50%.

NYHA Class IV.

Patients with HFpEF secondary to significant uncorrected primary valvular disease.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: L-Citrulline, Then PlaceboExperimental treatment 2 interventions
Group B: BH4, Then PlaceboExperimental treatment 2 interventions
Group C: Atorvastatin, Then PlaceboExperimental treatment 2 interventions
Group D: Placebo, Then L-CitrullineExperimental treatment 2 interventions
Group E: Placebo, Then BH4Experimental treatment 2 interventions
Group F: Placebo, Then AtorvastatinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Flow-mediated dilation (FMD)

Peak change in brachial artery diameter (%)

Time frame
Baseline, Day 90

Secondary outcomes

1

Passive Limb Movement (PLM)

Peak change in leg blood flow (ml/min)

Time frame
Baseline, Day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

University of Utah

Collaborator

Source ClinicalTrials.gov
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