- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02918552
Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction (ONOH)
Nitrite Benefits to Mediate Fatigability in Older HFpEF Patients
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- UPMC Montefiore Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥70 years
Diagnosis of HFpEF [adapted from the 2016 European Society of Cardiology (ESC) Guidelines to include:
1. Prior diagnosis of HF via one of these:
- medical record diagnosis by attending cardiologist
- verbal confirmation of HFpEF with attending cardiologist
- PI review of medical record to confirm HFpEF AND 2. Ejection Fraction % ≥40
- Clinically stable (euvolemic; baseline heart rate <100 bpm) and without hospitalization or invasive cardiac procedure for 6 weeks
- Patients using 81 milligram (mg) aspirin (ASA) will be eligible, but will be asked to hold the medication for 3 days prior to biopsy. This technique has previously been used with consistent safety. Patients will also be asked to avoid non-steroidal anti-inflammatory medications (NSAIDs) for 2 days prior to the biopsy.
- Patients using anti-thrombin and anti-platelet therapy will plan to modify prior to muscle biopsies individually in coordination with the participant's primary cardiologist.
Exclusion Criteria:
- Allergy to lidocaine
- BP >180/95 or <100/60
- Anemia: Hgb<11.0 (♂),10.0 (♀)
- Dementia or inability to give informed consent
- End-stage malignancy
- Severe orthopedic exercise limitation
- Use of chronic oral corticosteroids or other medications that affect muscle function.
- Chronic alcohol or drug dependency.
- Any bleeding disorder that would contraindicate biopsy such as history of clinically significant bleeding diathesis (e.g., Hemophilia A or B, Von Willebrand's Disease or congenital Factor VII deficiency).
- Psychiatric hospitalization within the last 3 months
- Major cardiovascular event or procedure within the prior 6 weeks
- HF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction). If valve replacement has been performed, patient may not be enrolled for 12 months after this procedure.
- Severe uncorrected primary valvular heart disease (if valve replacement has been performed, patients will not be eligible for at least 12 months)
- Mechanical valve replacement requiring warfarin
- Peripheral or pulmonary artery disease
- Currently taking clopidogrel for a recent stent placement and/or a complex atherosclerotic lesion such that holding clopidogrel creates disproportionate risk.
- Current use of organic nitrates or phosphodiesterase type 5 inhibitors (PDE5s)
- Unable to hold warfarin or use bridging therapy, or to hold aspirin for 3 days (81 mg), 3 days (325 mg) prior to muscle biopsy or thienopyridine medications for 5 days prior to muscle biopsy.
- Subjects with diabetes whose HgbA1c >10.0
- Other chronic unstable disease such as active neoplasm, end stage chronic kidney, liver or other organ disease,
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Treatment
20 or 40 mg sodium nitrite tid
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Subjects to receive active study drug three times daily during treatment period and then post treatment testing period.
다른 이름들:
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위약 비교기: Control
20 or 40 mg placebo tid
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Subjects randomized to placebo to receive three times daily during treatment period and then post treatment testing period.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Cardiorespiratory Fitness
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Assessment of peak Oxygen uptake (VO2) maximum via symptom limited exercise testing
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Perceived Fatigability
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
|
Assessment of Rate of Perceived Exertion (RPE) during steady state exercise testing at the last minute of the test.
The RPE scale (Rate of Perceived Exertion) goes from 6-20 with a higher number indicating more effort and possibly a worse outcome.
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Bioenergetics: In-Vivo 31P MRS Respirations
기간: Week 3 (pre drug) to week 10(post drug); approx. 8 weeks
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Phosphocreatine reuptake after exercise during the kicking exercise in the 31P MRS (magnetic resonance spectroscopy)
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Week 3 (pre drug) to week 10(post drug); approx. 8 weeks
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Bioenergetics: Ex-Vivo Mitochondrial Respiration Analysis
기간: Week 5 (pre-drug) to week 16 (post-drug); approx. 8 weeks
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Mitochondrial respiration was analyzed by assessing O2 consumption by skeletal muscle mitochondria at Energetic State 3.1 using the Oroboros instrument.
This state is generally used a marker for mitochondrial efficiency.
Increases in consumption are generally linked to a better outcome.
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Week 5 (pre-drug) to week 16 (post-drug); approx. 8 weeks
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Exercise-induced Changes in Pulmonary Arterial Pressure
기간: Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
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Pulmonary arterial pressure, an indication of cardiopulmonary hemodynamics and cardiac function, was measured at rest and at peak exercise during an invasive cardiopulmonary exercise test.
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Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
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Exercise-induced Changes in Pulmonary Capillary Wedge Pressure
기간: Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
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Pulmonary capillary wedge pressure, an indication of cardiopulmonary hemodynamics and cardiac function, was measured at rest and at peak exercise during an invasive cardiopulmonary exercise test.
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Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
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Patients With Pulmonary Hypertension
기간: Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
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Right Ventricular-Pulmonary Artery Coupling, assessed by right ventricular ejection fraction (RVEF) and pulmonary artery systolic pressure (PASP), decreases with worsening right heart failure.
We will be measuring this by assessing RVEF and PASP during invasive cardiopulmonary exercise testing in patients that meet criteria for pulmonary hypertension.
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Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
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Steps From Accelerometry Assessment of Daily Activity
기간: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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Actigraph device-specific activity steps on daily-wear wrist device based on movement.
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Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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Sedentary Events From Accelerometry Assessment of Daily Activity
기간: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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Assessment of daily activity using accelerometry on a daily-wear wrist device. Sedentary bout is a triggered stint of time that the patient is not moving or has low level of activity sensed by the accelerometer. |
Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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Light Activity Duration From Accelerometry Assessment of Daily Activity
기간: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
|
Assessment of daily activity using accelerometry on a daily-wear wrist device. Light activity is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate. |
Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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Moderate to Vigorous Physical Activity From Accelerometry Assessment of Daily Activity
기간: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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Assessment of daily activity using accelerometry on a daily-wear wrist device. MVPA is Moderate-to-vigorous physical activity that is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate. |
Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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Vector Magnitude Counts From Accelerometry Assessment of Daily Activity
기간: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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Assessment of daily activity using accelerometry on a daily-wear wrist device. Vector Magnitude in counts per day are accelerations in 3 dimensions that indicate activity. More counts is associated with more activity. More counts in a shorter duration of time indicate light, moderate, and vigorous activity. |
Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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Sedentary Event Duration From Accelerometry Assessment of Daily Activity
기간: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
|
Assessment of daily activity using accelerometry on a daily-wear wrist device. Sedentary bout is a triggered stint of time that the patient is not moving or has low level of activity sensed by the accelerometer. |
Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
|
Light Activity Events Percentage of Day From Accelerometry Assessment of Daily Activity
기간: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
|
Assessment of daily activity using accelerometry on a daily-wear wrist device. Light activity is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate. |
Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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Moderate to Vigorous Physical Activity Percentage From Accelerometry Assessment of Daily Activity
기간: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
|
Assessment of daily activity using accelerometry on a daily-wear wrist device. MVPA is Moderate-to-vigorous physical activity that is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate. |
Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Adiponectin
기간: Week 5 (pre drug) to week 16 (post drug); approx. 8 weeks
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Change in adiponectin
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Week 5 (pre drug) to week 16 (post drug); approx. 8 weeks
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Blood Nitrate
기간: Week 5 (pre drug) to week 16 (post drug); approx. 8 week
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Change in blood levels to assess efficacy of study drug
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Week 5 (pre drug) to week 16 (post drug); approx. 8 week
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Brain Natriuretic Protein
기간: Week 5 (pre drug) to week 16 (post drug); approx. 8 weeks
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Change in brain natriuretic protein (BNP)
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Week 5 (pre drug) to week 16 (post drug); approx. 8 weeks
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Cardiopulmonary Exercise Testing: iCPET
기간: Week 3 (pre-drug) to week 10 (post drug); approx. 8 weeks
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Invasive cardiopulmonary exercise testing
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Week 3 (pre-drug) to week 10 (post drug); approx. 8 weeks
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Cardiopulmonary Exercise Testing; nCPET
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Non-invasive cardiopulmonary exercise testing
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Cognitive Function
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Change in pre and post scores on the Montreal Cognitive Assessment
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Co-morbid Illness
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Change in pre and post scores on the Charlson Comorbidity Index
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Co-morbidity Medications
기간: Week 1 pre drug to week 16 post drug
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Medications for comorbidity managment
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Week 1 pre drug to week 16 post drug
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Echocardiogram
기간: Week 1 pre-drug to week 16 post drug
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Change in cardiac strain
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Week 1 pre-drug to week 16 post drug
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Fatigability
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Change in pre and post scores on the Pittsburgh Fatigability Index
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Frailty Index Assessment
기간: Week 1 screening pre-drug to week 16 post drug
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Physician assessment of frailty using the Canadian Clinical Frailty Scale
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Week 1 screening pre-drug to week 16 post drug
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Gene Expression
기간: Week 5 (pre drug) to week 16 (post drug); approx. 8 week
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Change in DNA from Polymerase Chain Reaction analysis
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Week 5 (pre drug) to week 16 (post drug); approx. 8 week
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Glomerular Filtration Rate
기간: Week 5 (pre drug) to week 16 (post drug); approx. 8 week
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Change in glomerular filtration rate (GFR)
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Week 5 (pre drug) to week 16 (post drug); approx. 8 week
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Glycosylated Hemoglobin
기간: Week 5 (pre drug) to week 16 (post drug); approx. 8 week
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Change in glycosylated hemoglobin (HgbA1c)
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Week 5 (pre drug) to week 16 (post drug); approx. 8 week
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Hematocrit
기간: Week 1 pre drug to week 16 post drug
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Change in hematocrit
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Week 1 pre drug to week 16 post drug
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Hemoglobin
기간: Week 1 pre drug to week 16 post drug
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Change in hemoglobin
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Week 1 pre drug to week 16 post drug
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Hemodynamics; Blood Pressure
기간: Week 1 pre drug to week 16 post drug
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Change in Blood pressure
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Week 1 pre drug to week 16 post drug
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Hemodynamics; Heart Rate
기간: Week 1 pre drug to week 16 post drug
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Change in heart rate
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Week 1 pre drug to week 16 post drug
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Muscle Protein
기간: Week 5 (pre drug) to week 16 (post drug); approx. 8 week
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Change in protein content of muscle fiber
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Week 5 (pre drug) to week 16 (post drug); approx. 8 week
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Near Infrared Spectroscopy
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Assessment of blood flow during exercise
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Pain
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Change in pre and post scores on the McGill Pain Questionnaire
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Physical Frailty and Balance
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Change in score on Standard Physical Performance Battery at visit 2 pre drug and visit 5
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Physical Activity
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Change in pre and post scores on the CHAMPS (Community Healthy Activities Program for Seniors) Activities Questionnaire for Older Adults-physical activity
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Quality of Life
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Change in pre and post scores on the Kansas City Cardiomyopathy Questionnaire subject self reported responses
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Submaximal Exercise Performance
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Change in distance on six minute walk test
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
|
Self-efficacy
기간: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Change in pre and post scores on the Sullivan Cardiac Self Efficacy questionnaire
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Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
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Thyroid Stimulating Hormone
기간: Week 5 (pre drug) to week 16 (post drug); approx. 8 weeks
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Change in thyroid stimulating hormone (TSH)
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Week 5 (pre drug) to week 16 (post drug); approx. 8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Daniel E Forman, MD, University of Pittsburgh
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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