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Inflammatory Response to Salt in Essential Hypertension

2012년 8월 12일 업데이트: Carmine Zoccali

Procalcitonin and the Inflammatory Response to Salt in Essential Hypertension: a Randomised Cross-over Clinical Trial.

Salt is a main environmental risk factor involved in atherosclerotic complications and in the high risk of a variety of cardiovascular (CV) diseases including hypertension, left ventricular hypertrophy (LVH), chronic kidney disease (CKD) and heart failure. The link between sodium and cardiovascular disease is complex and involves blood pressure (BP) dependent and independent mechanisms. Among the latter, inflammation is suspected to be a major effector of arterial damage brought about by the salt excess in animal models. In humans, C-Reactive Protein (CRP) associated directly with dietary salt intake in a population-based survey but such a link was not confirmed in other studies. This apparent discrepancy may depend on the observational (i.e., open to confounding) nature of these studies. Inflammatory cytokines are essential for the short term systemic response to environmental stressors. For example it is well established that TNF-α, a cytokine that modulates renin gene expression by signalling via TNF-receptor 2, exerts a protective effect for the myocardium in a stressful condition like experimental cardiac ischemia while low levels of adiponectin have a detrimental effect in the same setting. Thus, the inflammation-sodium relationship may be non-linear and severe salt restriction may actually trigger inflammation, a hypothesis suggested by the observation that biomarkers of inflammation rose in response to salt depletion in a sequential study in essential hypertensives. However, the lack of randomization in this study leaves open the question whether the observed pro-inflammatory effect was due to change in salt intake or to other, unmeasured time-dependent effect(s). With this background in mind the investigators setup a randomized, single masked, cross-over study to assess the effect of a short term very low salt diet on biomarkers of innate immunity in patients with uncomplicated essential hypertension.

연구 개요

상태

완전한

상세 설명

The protocol was in conformity with the ethical guidelines of our institution and informed consent was obtained by each participant. During the run-in phase of the study, which lasted 1 month, patients underwent standard arterial pressure measurements on two separate occasions (at least 10 days apart) and were considered eligible for the study if their casual arterial pressure exceeded 140/90 mmHg.

Patients were randomized to either a 10-20 mmol sodium diet plus sodium tablets (180 mEq/die) to achieve a 200 mmol intake /day, or the same diet plus identical placebo tablets, each for two weeks. At the end of each of these two-week periods, all patients underwent a 24-hours urine collection, a fasting blood sampling and a 24h ambulatory blood pressure monitoring (see below).

Ambulatory monitoring was performed with a device conforming with the AAMI criteria (Takeda 2420 model 7, Takeda Medical, Osaka, Japan). Between 08.30 and 11.30 hours, after placement of the device in the left (non-dominant) arm, the patients rested quietly in an armchair for 15 min and arterial pressure was taken automatically three times (at 5 min intervals). Patients then went home and remained indoors throughout all the recording day. They were instructed to spend a relaxed, quiet day avoiding physical efforts. Recordings were set at 15 min intervals between the 07.00 to 22.00 hours and every 30 min during the sleeping hours (22.00 pm to 07.00). The calibration of the ambulatory recorder was performed against a mercury sphygmomanometer before each recording. Patients were classified as salt-sensitive if the changes in mean arterial pressure between low and high salt diet was > 10%.

Blood sampling was performed on the last day of each period after 45 minutes supine rest. The patients were specifically instructed not to alter their smoking habits, alcohol and coffee intake and not to modify the level of physical activity throughout the study.

Urinary sodium was measured by an ion-selective electrode using a Beckman (Fullertone, CA, USA) EA-2 Electrolyte Analyser. Serum and urine creatinine was measured by a colorimetric method using a COBAS-Mira spectrophotometer (Roche, Basel, Switzerland). The measurements of plasma renin activity (PRA) and plasma aldosterone concentration were performed by radioimmunoassay (RIA) using a commercially available kit (Technogenetics-Milan, Italy).

Biomarkers of inflammation and endothelial integrity/function High sensitivity C-Reactive Protein (hs-CRP) was measured in plasma by a nephelometric method (Dade-Behring, Scoppito, L'Aquila, Italy) (intra-assay CV: 3.5%; inter-assay CV: 3.4%; normal range < 2.87 mg/L). Interleukin-6 (intra-assay CV: 2.6%; inter-assay CV: 4.5%, normal range < 12.5 pg/mL) and TNF-α (intra-assay CV: 4.7%; inter-assay CV: 5.8%, normal range < 15.6 pg/mL) were measured by commercially available RIA kits (R&D System, Minneapolis, USA). High sensitivity procalcitonin (PCT) (intra-assay CV: 2-3% normal value < 0.05 ng/mL) was measured by an immunofluorescence method (Kriptor, BRAHMS, Henningsdorf, Germany). Plasma Adiponectin (intra-assay CV: 3.9%; inter-assay CV: 8.4%) and Leptin (intra-assay CV: 5.0%; inter-assay CV: 4.5%) were measured by a RIA kit (Linco Research Missouri, USA).

연구 유형

중재적

등록 (실제)

32

단계

  • 3단계

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Patients with uncomplicated, untreated essential hypertension (age>18 years).

Exclusion Criteria:

Patients with secondary hypertension, liver disease, neoplasia and other chronic disease.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Effect of salt intake
During the high salt intake period, patients received a 10-20 mmol sodium diet plus sodium tablets (180 mEq/die) to achieve a 200 mmol intake /day for two weeks. During the low salt intake period, patients received a 10-20 mmol sodium diet + placebo tablets for two weeks.
During the high salt intake period, patients received a 10-20 mmol sodium diet plus sodium tablets (180 mEq/die) to achieve a 200 mmol intake /day for two weeks

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline of inflammatory biomarkers (TNF-alpha, procalcitonin, IL-6, C-Reactive Protein, adiponectin and leptin) in response to salt intake.
기간: Inflammatory biomarkers were measured at baseline and at the end of two-week diet periods.
Patients were randomized to either a 10-20 mmol sodium diet plus sodium tablets (180 mEq/die) to achieve a 200 mmol intake /day, or the same diet plus identical placebo tablets, each for two weeks.
Inflammatory biomarkers were measured at baseline and at the end of two-week diet periods.

2차 결과 측정

결과 측정
측정값 설명
기간
Blood pressure response to salt intake.
기간: 24h ambulatory blood pressure was measured at baseline and at the end of two-week diet periods.
Patients were randomized to either a 10-20 mmol sodium diet plus sodium tablets (180 mEq/die) to achieve a 200 mmol intake /day, or the same diet plus identical placebo tablets, each for two weeks.
24h ambulatory blood pressure was measured at baseline and at the end of two-week diet periods.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 의자: Carmine Zoccali, Prof., Nephrology, Dialysis and Transplantation Unit and CNR-IBIM

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 3월 1일

기본 완료 (실제)

2011년 3월 1일

연구 완료 (실제)

2011년 3월 1일

연구 등록 날짜

최초 제출

2012년 8월 7일

QC 기준을 충족하는 최초 제출

2012년 8월 12일

처음 게시됨 (추정)

2012년 8월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2012년 8월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 8월 12일

마지막으로 확인됨

2012년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • SS-011-RC

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