Phase 1 Heart Disease Trial, Recruiting NCT07219511 Sponsor: Vasa Therapeutics Condition: Heart Disease
Back to Heart Disease

Phase 1 Heart Disease Trial, Recruiting

NCT07219511
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 50 or older at the time of signing the consent form
  • People who have been diagnosed with a type of heart failure called HFpEF, based on recognised medical guidelines
  • People whose heart failure symptoms fall into a moderate category known as NYHA Class II or III (confirm with trial site)
  • People whose heart pumping function (measured by a heart ultrasound) shows a result of 50% or higher, along with signs of heart failure
  • People who have an elevated level of a heart stress marker called NT-proBNP on a blood test at the screening visit
  • People who have a level of a specific protein marker called NordicPRO-C6™ of 11 ng/mL or higher at the screening visit
  • People who have been on a stable dose of all their heart failure medicines for at least 4 weeks before the screening visit
  • People who weigh at least 110 lbs (50 kg) and have a body mass index (BMI) between 18 and under 45
  • Male participants who agree to the trial's contraception requirements, and female participants who are not able to become pregnant
  • People who are able to understand and willing to sign a written consent form
  • People who are willing and able to follow all trial procedures and requirements

Who may not be able to join:

  • Women who are pregnant or breastfeeding
  • People who have a known allergy or sensitivity to the study drug, VS-041
  • People who have heart or blood vessel conditions other than HFpEF
  • People who have an active illness at the time of screening, such as a current bacterial or viral infection
  • People with a history of illicit drug or alcohol misuse that the lead doctor believes could affect their ability to participate
  • People who have an active ongoing viral infection such as Hepatitis B, Hepatitis C, or HIV at the time of screening
  • People whose heart failure has recently worsened severely within the 30 days before the screening visit
  • People who have had a lung disease within the 12 months before the screening visit
  • People with a current, untreated, or recently treated cancer (less than 5 years in remission from a significant cancer)
  • People with any other condition, including mental health conditions, that the lead doctor believes would prevent them from completing the trial
  • People who have taken part in another clinical trial involving an experimental treatment within the last 6 months
  • People who, for any other reason, the lead doctor believes should not participate in the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 760-230-3398

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Vasa Therapeutics
Registry
ClinicalTrials.gov
Start date
4 November 2025
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Participant incidence of treatment-emergent adverse events (TEAEs); Change from baseline over time in serum NordicPRO-C6; Change from baseline over time in serum endotrophin; Change from baseline over time in serum NT-proBNP

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov