Study of the Acute Effects of Triheptanoin in Heart Failure

• Status: Withdrawn
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center

Criteria

Inclusion Criteria:

Patients will be eligible for inclusion in this protocol if they satisfy the following criteria:

1. DCM with left ventricular ejection fraction (LVEF) ≤40%

2. New York Heart Association (NYHA) class III-IV symptoms

3. age ≥18

4. an indwelling PA catheter

5. and an anticipated clinical requirement for a PA catheter for at least five days.

Exclusion Criteria:

Patients will be ineligible for inclusion in this protocol if they have any of the following:

1. urgent (<6 hr) need for (or increase in) inotropic support (INTERMACS profile 1)

2. diabetes mellitus

3. known disorder of the respiratory chain or mitochondrial cardiomyopathy

4. significant hyperlipidemia with triglyceride value >300mg/dL

5. normal cardiac index (>2.5L/min/m2) on initial right heart catheterization

6. indwelling intra-aortic balloon pump

7. chronic liver disease

8. severe renal dysfunction (CKD stage IV-V) with creatinine clearance <30 mL/min/1.73m2

9. more than moderate valvular stenosis or regurgitation

10. pregnancy or breastfeeding

11. peripartum cardiomyopathy diagnosed within the past year

12. inability to provide informed consent