Status:

RECRUITING

Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

Lead Sponsor:

Montefiore Medical Center

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Vascular Diseases

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

Brief Summary

Contemporary left ventricular assist device (LVAD) therapy improves survival during advanced heart failure but vascular aging develops rapidly leading to major adverse events including stroke and blee...

Detailed Description

Over 6.5 million individuals in the United States suffer from heart failure (HF), with the burden of this disease expected to grow over the next decade. Approximately 300,000 of these patients have ad...

Eligibility Criteria

Inclusion

  • Over 18 years of age
  • Supported by a durable LVAD or planned to undergo placement of a durable LVAD
  • Be able to give informed consent

Exclusion

  • History of pre-existing aortic valve prosthesis or an aortic graft
  • Allergy to sildenafil
  • Taking any nitric oxide (NO) donor medications
  • History of complete carotid occlusion

Key Trial Info

Start Date :

March 12 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2029

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06510322

Start Date

March 12 2025

End Date

December 1 2029

Last Update

March 25 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Montefiore Medical Center

The Bronx, New York, United States, 10461