Study of the Acute Effects of Triheptanoin in Heart Failure

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Congestive Heart Failure, Non-ischemic Cardiomyopathy

In brief

Patients with dilated cardiomyopathy who present for indwelling right heart catheterization will be enrolled and randomized to either control or triheptanoin oil for five days. Hemodynamics will be assess serially.

Key facts

Study ID

NCT01787851

Run by

University of Texas Southwestern Medical Center

People needed

0

Starts

2013-02-01

Expected to finish

2014-02-01

Last updated by the study team

2018-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be eligible for inclusion in this protocol if they satisfy the following criteria:
• DCM with left ventricular ejection fraction (LVEF) ≤40%
• New York Heart Association (NYHA) class III-IV symptoms
• age ≥18
• an indwelling PA catheter
• and an anticipated clinical requirement for a PA catheter for at least five days.

You may not qualify if…

• Patients will be ineligible for inclusion in this protocol if they have any of the following:
• urgent (<6 hr) need for (or increase in) inotropic support (INTERMACS profile 1)
• diabetes mellitus
• known disorder of the respiratory chain or mitochondrial cardiomyopathy
• significant hyperlipidemia with triglyceride value >300mg/dL
• normal cardiac index (>2.5L/min/m2) on initial right heart catheterization
• indwelling intra-aortic balloon pump
• chronic liver disease
• severe renal dysfunction (CKD stage IV-V) with creatinine clearance <30 mL/min/1.73m2
• more than moderate valvular stenosis or regurgitation
• pregnancy or breastfeeding
• peripartum cardiomyopathy diagnosed within the past year
• inability to provide informed consent

Where it is running

• University of Texas-Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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