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Study of the Acute Effects of Triheptanoin in Heart Failure (ACETO-TCA)

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ClinicalTrials.gov Identifier: NCT01787851
Recruitment Status : Unknown
Verified February 2013 by Aslan Turer, University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
First Posted : February 11, 2013
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Non-ischemic Cardiomyopathy Drug: Triheptanoin oil Phase 1 Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Assessment of the Clinical Effects of Triheptanoin Oil to Target Cardiac Anaplerosis in Congestive Heart Failure- Acute Study
Study Start Date : February 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Triheptanoin oil
The standard dose of triheptanoin oil for adults is 1-2gm/kg/24 hours. For purposes of this study, we will administer 0.25mg/kg four-times per day. The liquid study drug will be mixed into sugar-free, low fat yogurt, pudding or nutritional supplement shake, depending on patient preference.
Drug: Triheptanoin oil
Placebo Comparator: Simple sugar
0.25mg/kg of sugar syrup will be mixed into sugar-free, low fat yogurt, pudding or nutritional supplement shake four-times per day before meals.


Outcome Measures

Primary Outcome Measures :
  1. Cardiac output/index [ Time Frame: 6 hours ]
    The main outcome of interest is the change in cardiac index over the first 6 hours of the study period (before initiation of any other vasoactive medications). Pre-and post-cardiac index will be compared with a paired t-test. With 10 patients per study group, we have 80% power to detect a clinically significant 20% difference (0.4L/min/m2) in cardiac index between treatment assignments. Assuming the need for a non-parametric analysis a "standard" 20% increase in sample size will need sought. This yields a final 12 patient per group (n=24 total) sample size


Secondary Outcome Measures :
  1. Cardiac Output/index and pulmonary capillary wedge pressure [ Time Frame: 5 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787851


Contacts
Contact: Aslan T Turer, MD, MHS 2146457558 aslan.turer@utsouthwestern.edu
Contact: Toni Halliburton 2146507500 toni.halliburton@utsouthwestern.edu

Locations
United States, Texas
University of Texas-Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Aslan T Turer, MD, MHS    214-645-7500    aslan.turer@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Aslan T Turer, MD, MHS UT-Southwestern
More Information

Responsible Party: Aslan Turer, Assistant Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01787851     History of Changes
Other Study ID Numbers: UTSW 65827-1
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by Aslan Turer, University of Texas Southwestern Medical Center:
Heart failure
Anaplerosis
Medium-chain fatty acid

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases