RECRUITING

Novel Approaches for Improving Vascular Function in Veterans With HFpEF

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction Inflammation vascular health exercise tolerance HFpEF nitric oxide

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Novel Approaches for Improving Vascular Function in Veterans With HFpEF

Quick Facts

Study Start:2021-05-19

Study Completion:2030-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06312748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

D. W. Wray

CONTACT

858-205-3078

walter.wray@hsc.utah.edu

Misti Seppi

CONTACT

435-714-1516

misti.seppi@hsc.utah.edu

Study Locations (Sites)

George E. Whalen VA Medical Center

Salt Lake City, Utah, 84128

United States

Collaborators and Investigators

Sponsor: D. Walter Wray

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-19

Study Completion Date2030-09-30

Study Record Updates

Study Start Date2021-05-19

Study Completion Date2030-09-30

Terms related to this study

Keywords Provided by Researchers

vascular health
exercise tolerance
HFpEF
nitric oxide

Additional Relevant MeSH Terms

HFpEF - Heart Failure With Preserved Ejection Fraction
Inflammation