- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02357017
Mechanisms of Refractory Hypertension (High and Low Salt Diet)
연구 개요
상세 설명
We are proposing a unique phenotype of antihypertensive treatment failure that we refer to as refractory HTN. We have come to feel that while resistant (RHTN) represents a broad phenotype with multiple and overlapping etiologies of treatment resistance, there is a unique subset of patients who never achieve BP control in spite of maximal therapy. In a recently published retrospective analysis of our clinic experience, we found that patients with refractory HTN comprised about 10% of patients referred to us for RHTN.
A large number of intervention studies have verified the benefit of dietary salt restriction to reduce BP. We made such an assessment in a prospective, randomized, cross-over comparison of high- and low salt diets in 12 patients with confirmed RHTN. The average reduction in BP going from high to the low salt diet was 23/10 mmHg in the clinic and 20/10 mmHg during 24-hr ambulatory BP monitoring. These dramatic results demonstrated that patients with RHTN are exquisitely salt-sensitive and highlight the degree of BP reduction that can be accomplished with meaningful salt restriction. However, we are proposing the novel hypothesis that refractory HTN is mechanistically unique from RHTN in that it is not secondary to recalcitrant fluid retention.
Determining an association between dietary salt restriction and severity of obstructive sleep apnea (OSA) would potentially help us to find new therapies guided towards achieving better control of BP in patients with refractory HTN. We will investigate the effect of dietary salt intake on severity of OSA vascular function in patients with refractory HTN by doing vascular studies (pulse wave analysis/velocity, calculating thoracic impedance)).
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult subjects ≥ 19 years of age
- Refractory hypertension defined as office BP > 140/90 that is uncontrolled with at least 5 different classes of antihypertensive medications
- Self-reported adherence >80% with prescribed antihypertensive medications
Exclusion Criteria:
- Severe hypertension (office BP >160/100 mm Hg)
- History of congestive heart failure (ejection fraction of <40%)
- Chronic kidney disease (creatinine clearance <60 ml/min)
- History of cardiovascular disease (stroke, TIA, myocardial infarction, or revascularization procedure)
- White coat hypertension defined as office BP >140/90 mm Hg and ambulatory daytime BP <135/85 mm Hg
- Pregnant or nursing women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Low salt diet
The low-salt meals will be formulated to provide 50 mmol of sodium per day.
Two diets with different caloric amounts (2000 or 2500) will be available.
|
|
활성 비교기: High salt diet
High dietary salt intake, NaCl tablets (6 grams/day) will added to the subject's study diet in order to increase dietary sodium intake to >250 mmol/day.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in 24-hour ambulatory systolic blood pressure (BP).
기간: baseline to 4 weeks
|
The mean change in blood pressure for each group after receiving 4 weeks of either a low salt diet compared to High dietary salt intake.
The low-salt meals will be formulated to provide 50 mmol of sodium per day.
Two diets with different caloric amounts (2000 or 2500) will be available.
High dietary salt intake, NaCl tablets (6 grams/day) will added to the subject's study diet in order to increase dietary sodium intake to >250 mmol/day.
|
baseline to 4 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: David A. Calhoun, MD, Cardiology Department - University of Alabama at Birmingham
연구 기록 날짜
연구 주요 날짜
연구 시작
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 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. .
NaCl tablets에 대한 임상 시험
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