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NCT01358409 · ClinicalTrials.gov registry record · Early Phase 1
Regression of Myocardial Steatosis by Nebivolol
A Early Phase 1 study of Cardiac Steatosis and Lipotoxicity, sponsored by Lidia Szczepaniak.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01358409: Completed Early Phase 1 study of Cardiac Steatosis and Lipotoxicity, sponsored by Lidia Szczepaniak.
NCT01358409 is a Early Phase 1 study of Cardiac Steatosis and Lipotoxicity that has completed, run by Lidia Szczepaniak. The registered enrollment target is 31 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01358409, a Early Phase 1 study of Cardiac Steatosis and Lipotoxicity, has completed, sponsored by Lidia Szczepaniak.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Within large number of patients with obesity, it is crucial to determine who is at the greatest risk for development of chronic heart disease. The investigators previous studies suggest that an excessive accumulation of fat in heart cells precedes the development of obesity-related pathologies and may serve as a biomarker of heart disease in high-risk population. Until now, the evaluation of fat in the human heart was possible postmortem or by biopsy. The investigators novel magnetic resonance spectroscopy technique enables the quantification of intracellular lipid content non-invasively and repeatedly in humans in vivo. It could be used to better screen and treat obese patients at risk for the development of metabolic disease. The investigators hypothesize that in obese humans with elevated myocardial triglycerides, treatment with Nebivolol will reduce myocardial fat and will improve heart function.
Primary Outcome
Regression of myocadial triglycerides using MR spectroscopy at two time points, one prior to receiving Nebivolol and six months after continuous low dose Nebivolol treatment.
Conditions Studied
Interventions
- DRUG Nebivolol
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-04-01 |
| Est. Completion | 2013-02-11 |
| Phase | Early Phase 1 |
What the finished NCT01358409 record still lists
NCT01358409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Cardiac Steatosis and Lipotoxicity appearing as the primary indexed condition, and to 1 intervention - of which Nebivolol is the first listed.
NCT01358409 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01358409 about?
NCT01358409 is a clinical study titled "Regression of Myocardial Steatosis by Nebivolol". Within large number of patients with obesity, it is crucial to determine who is at the greatest risk for development of chronic heart disease. The investigators previous studies suggest that an excessive accumulation of fat in heart cells precedes the development of obesity-related pathologies and m...
What is the current status of trial NCT01358409?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 31 participants. The study started on 2011-04-01. Estimated completion is 2013-02-11.
What conditions does trial NCT01358409 study?
This clinical trial studies the following conditions: Cardiac Steatosis and Lipotoxicity.
What interventions are being tested in trial NCT01358409?
The interventions under investigation include: Nebivolol (DRUG).
Who is sponsoring clinical trial NCT01358409?
This trial is sponsored by Lidia Szczepaniak, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01358409 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01358409's enrollment target sits among peer trials
31 794th of 2000 higher than 1,195 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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