Clinical trial
Novel Approaches for Improving Vascular Function in Veterans With HFpEF
Name
138675
Description
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).
Trial arms
Trial start
2021-05-19
Estimated PCD
2028-09-30
Trial end
2030-09-30
Status
Recruiting
Phase
Early phase I
Treatment
L-Citrulline
100 mg tablet
Arms:
L-Citrulline, Then Placebo, Placebo, Then L-Citrulline
Placebo for L-Citrulline
L-Citrulline-matched Placebo tablet
Arms:
L-Citrulline, Then Placebo, Placebo, Then L-Citrulline
BH4
10mg/kg
Arms:
BH4, Then Placebo, Placebo, Then BH4
Other names:
Kuvan®, sapropterin dihydrochloride
Placebo for BH4
BH4-matched Placebo
Arms:
BH4, Then Placebo, Placebo, Then BH4
Atorvastatin
10 mg tablet
Arms:
Atorvastatin, Then Placebo, Placebo, Then Atorvastatin
Other names:
Lipitor®
Placebo for Atorvastatin
Atorvastatin-matched Placebo
Arms:
Atorvastatin, Then Placebo, Placebo, Then Atorvastatin
Size
90
Primary endpoint
Flow-mediated dilation (FMD)
Baseline, Day 90
Eligibility criteria
Inclusion Criteria:
* 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) ≥150 pg/mL or NT-proBNP ≥600 pg/mL at Visit 1, or a BNP ≥100 pg/mL (or NT-proBNP ≥400 pg/mL) and a hospitalization for heart failure within the last 12 months.
Exclusion Criteria:
* 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.
* Active liver disease or unexplained persistent elevations in serum transaminase.
* Women who are pregnant or may become pregnant.
* Patients currently treated with antioxidants, nitrates, PDE-5 inhibitors, or statins.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'A block randomization method will be used to randomize participants into equal groups and will be handled by investigational pharmacist.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-03-21
1 organization
3 products
1 drug
2 indications
Organization
D. Walter WrayProduct
L-CitrullineIndication
InflammationProduct
BH4Product
PlaceboDrug
Atorvastatin