Phase 1 Heart Disease Trial, Recruiting NCT07465653 Sponsor: Novartis Pharmaceuticals Condition: Heart Disease
Back to Heart Disease

Phase 1 Heart Disease Trial, Recruiting

NCT07465653
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:

  • Adults aged 18 or older, both men and women
  • People with a moderate level of heart failure symptoms, classified as NYHA functional class II or III (meaning symptoms appear during ordinary or minimal physical activity) (confirm with trial site)
  • People whose heart pumps out less than 50% of blood with each beat, as measured by a heart scan
  • People with a specific protein level in the blood (called NT-proBNP) above a certain threshold at the time of screening — the threshold differs depending on whether the person has a normal heart rhythm or a condition called atrial fibrillation (confirm with trial site)
  • People who have been taking a heart failure medication called sacubitril/valsartan at a dose of at least 49/51 mg twice daily for at least 4 weeks before screening, with no recent dose changes

Who may not be able to join:

  • People who had a serious worsening of heart failure requiring urgent treatment within the 3 months before screening
  • People whose resting blood pressure (the top number) was below 105 mmHg at screening or at the start of the trial
  • People who had a heart attack, stroke, mini-stroke, major heart or blood vessel surgery, or a procedure to open blocked arteries within the 6 months before screening
  • People with significant problems with their heart valves (mitral or aortic), or anyone who has had a heart valve replacement — except where the mitral valve leak is caused by an enlarged heart
  • People whose kidneys are functioning below a certain level, as measured by a specific blood test called eGFR (below 30 ml/min/1.73m²)
  • People with a body mass index (a measure of body weight relative to height) above 40
  • People currently taking certain medications, including strong inhibitors or inducers of a liver enzyme called CYP3A4, a drug called vericiguat, PDE5 inhibitors (a class of medication), or nitroglycerin-based products (confirm with trial site)
  • Women who are able to become pregnant

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

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Phone: 1-888-669-6682

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
Registry
ClinicalTrials.gov
Start date
18 March 2026
Est. completion
24 September 2026

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Number of participants with Adverse Events (AEs); Number of participants with clinically significant changes in vital signs

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