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NCT06428097 · ClinicalTrials.gov registry record · Phase 1
Levothyroxine Supplementation for Heart Transplant Recipients
A Phase 1 study of Heart Transplant Infection and Heart Transplant Failure, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
- 1
- Study location
NCT06428097: Recruiting Phase 1 study of Heart Transplant Infection and Heart Transplant Failure, sponsored by University of California, San Francisco.
NCT06428097 is a Phase 1 study of Heart Transplant Infection and Heart Transplant Failure that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 97 participants, below the 157-participant average among 3 other Heart Transplant Infection trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06428097, a Phase 1 study of Heart Transplant Infection and Heart Transplant Failure, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.
Primary Outcome
Measured using the vasoactive-inotropic score (VIS) scale. VIS calculation: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min)
Conditions Studied
Interventions
- DRUG Normal saline
- DRUG Levothyroxine
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2024-03-29 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 1 |
What NCT06428097 shows while recruiting
NCT06428097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 157-participant average among 3 other Heart Transplant Infection trials with a reported enrollment target (38% lower).
The record links to 2 conditions, with Heart Transplant Infection appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT06428097 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06428097 about?
NCT06428097 is a clinical study titled "Levothyroxine Supplementation for Heart Transplant Recipients". This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be dou...
What is the current status of trial NCT06428097?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2024-03-29. Estimated completion is 2027-03-01.
What conditions does trial NCT06428097 study?
This clinical trial studies the following conditions: Heart Transplant Infection, Heart Transplant Failure.
What interventions are being tested in trial NCT06428097?
The interventions under investigation include: Normal saline (DRUG), Levothyroxine (DRUG).
Who is sponsoring clinical trial NCT06428097?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06428097 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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