- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02369913
A Metabolomic Approach to Probing Myocardial Fuel Shifts in Human Heart Failure
This proposal is designed to test the hypothesis that humans shift to reliance on ketone bodies as a cardiac fuel source during the development of HF. The investigator also propose that this shift to ketone utilization can be detected by metabolomic profiling of blood.
Specific Aim 1: To determine if the failing human heart exhibits increased extraction of blood-borne ketone bodies. Ketone bodies will be measured in coronary sinus, arterial, and central venous blood samples to determine AV differences. The HF group will be comprised of patients undergoing cardiac resynchronization therapy with an implantable cardioverter-defibrillator. The Control group will be compromised of patients without evidence of structural heart disease who are undergoing catheter ablation for supraventricular tachycardia.
Specific Aim 2: To determine whether blood samples from humans with HF display metabolomic signatures indicative of increased myocardial ketone body utilization. Quantitative targeted metabolomics will be performed on the samples described in Aim 1 to determine if metabolite markers (e.g. C4-OH acylcarnitine, acetylcarnitine, succinate) found to be associated with increased myocardial ketone body oxidation in animal models are increased in the human HF group compared to the controls.
연구 개요
상세 설명
After subjects agree to participate in this study and are scheduled to have cardiac resynchronization therapy, the research personnel will take 1 teaspoon of blood before and after the scheduled cardiac procedure for comparison.
Once subjects agree to participate in this study and are scheduled to have a catheter ablation procedure, research personnel will take 1 teaspoon of blood during the scheduled cardiac procedure.
These samples will be taken from catheters already placed during the scheduled cardiac procedure.
Blood will be sent to a lab at the Sanford-Burnham Metabolomics Core Facility in Orlando, Florida for analysis.
연구 유형
연락처 및 위치
연구 장소
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Florida
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Gainesville, Florida, 미국, 32610
- University of Florida
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Undergoing cardiac resynchronization therapy
- Undergoing sinus cannulation
Exclusion Criteria:
- NYHA class II-IV heart failure
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Heart failure subjects
Heart failure subjects undergoing cardiac resynchronization will have a blood drawn for this study.
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Both groups will have 1 teaspoon of blood drawn for analysis.
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Heart arrhythmia patients
Heart arrhythmia patients undergoing ablation will have a blood drawn for this study.
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Both groups will have 1 teaspoon of blood drawn for analysis.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Increased extraction of blood-borne ketone bodies
기간: 1 day
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Ketone bodies will be measured in coronary sinus, arterial, and central venous blood samples to determine AV differences
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1 day
|
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Determine whether heart failure blood samples display metabolomic signatures
기간: 1 day
|
Quantitative targeted metabolomics will be performed on the samples described in Outcome 1 to determine if metabolite markers (e.g.
C4-OH acylcarnitine, acetylcarnitine, succinate) found to be associated with increased myocardial ketone body oxidation in animal models are increased in the human HF group compared to the controls.
|
1 day
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Eileen Handberg, PhD, University of Florida
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .