Recruiting NCT07219511

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Phase I Interventional Heart Heart Failure With Preserved Ejection Fraction (HFPEF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: VS-041, Placebo.
Who it may be relevant to: Registry conditions: Heart, Heart Failure With Preserved Ejection Fraction (HFPEF). Basic parameters: from 50 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)

Participant incidence of treatment-emergent adverse events (TEAEs) [Time frame: From Baseline to Day 28]
Change from baseline over time in serum NordicPRO-C6 [Time frame: From Baseline to Day 28]
Change from baseline over time in serum endotrophin [Time frame: From Baseline to Day 28]
Change from baseline over time in serum NT-proBNP [Time frame: From Baseline to Day 28]

Secondary outcome measures (2)

Pharmacokinetic profiles and parameters derived for VS-041 - Tmax [Time frame: From Baseline to Day 28]
Pharmacokinetic profiles and parameters derived for VS-041 - Cmax [Time frame: From Baseline to Day 28]

Participants must meet all inclusion criteria to be eligible for trial participation.

Males or females ≥ 50 years of age at the time of signing the informed consent.
Diagnosis of HFpEF as defined by European Society of Cardiology or American College of Cardiology/American Heart Association criteria
NYHA Functional Class II or III
LVEF ≥ 50% demonstrated by echocardiography (ECHO) performed at Screening with evidence of heart failure
Elevated NT-proBNP at Screening
NordicPRO-C6™ ≥ 11 ng/mL at Screening.
Stable dose of all concomitant HF medications for at least 4 weeks prior to Screening.
Body weight of at least 110 lbs (50 kg) and body mass index (BMI) within the range ≥ 18 to < 45 kg/m2.
Males must agree to the contraception requirements and females must be of non-childbearing potential
Able to understand and willing to sign a written informed consent form (ICF).
Willing and able to comply with trial procedures and restrictions listed in the ICF and in this protocol.

Female trial participant who is pregnant or breastfeeding.
Known hypersensitivity to VS-041.
Cardiovascular disease other than HFpEF
Active intercurrent illness such as acute bacterial or viral infection.
History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation.
Active chronic viral infection such as Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) at Screening.
Acute decompensated HF within 30 days of Screening
Lung disease within 12 months prior to Screening
History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
History of any other condition including psychiatric disorders that, in the opinion of the PI, may preclude the participant from following and completing the protocol.
Have participated within the last 6 months in a clinical study involving an investigational product.
Any other reason which, in the opinion of the PI, would prevent the participant from participating in the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 21 centers

NCT: NCT07219511 · VS-041-102