Evaluating sacubitril-valsartan for heart failure patients with LVADs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to assess the safety and efficacy of sacubitril-valsartan, an angiotensin receptor-neprilysin inhibitor, in patients who have undergone implantation of a continuous flow left ventricular assist device (CF-LVAD). Participants will be monitored for short-term (3 months) and long-term (6 and 12 months) outcomes compared to standard oral vasodilator therapy. The study will include adults with stage D heart failure and will evaluate how well the new treatment is tolerated and its effectiveness in improving patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults (age ≥ 18 years)
2. Durable CF-LVAD for any indication
3. NYHA II to IV classification
4. LVEF \< 40%
5. Written informed consent

Exclusion Criteria:

1. Inability to comply with the conditions of the protocol
2. Any patient with durable CF-LVAD who has any one of the following:

   i. symptomatic hypotension or MAP \< 60 mm Hg at randomization,

   ii. eGFR \< 30 mL/min/1.73 m2 at randomization,

   iii. potassium \> 5.4 mM at randomization,

   iv. history of angioedema at randomization,

   v. history of unacceptable side effects with ACE inhibitor, ARB, or sacubitril-valsartan therapy at randomization,

   vi. use of vasoactive agents (e.g., dobutamine, dopamine, epinephrine, norepinephrine, phenylephrine, vasopressin, nitroglycerin, nitroprusside, epoprostenol) or parenteral diuretics in 24 hours preceding randomization.

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Jerry D Estep, MD — The Cleveland Clinic
• Study coordinator: Jerry D Estep, MD
• Email: estepj@ccf.org
• Phone: 216-444-7646

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.