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临床试验/NCT04746118
NCT04746118Unknown不适用

Effectiveness of Nutritional Intervention Alone or Associated With Other Non-pharmacological Interventions in Controlling Hypertension and Reducing Cardiovascular Risk - Randomized Clinical Trial

Hospital Universitário Clementino Fraga Filho2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
240
试验地点
2
主要终点
Blood pressure

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of diet change and other non-pharmacological treatments which includes physical activity and integrative therapies oriented to reduce the blood pressure in hypertensive patients.

详细描述

Despite advances in the pharmaceutical industry, blood pressure control remains the biggest challenge in the treatment of hypertension in Brazil and worldwide. In this context, besides the availability and use of antihypertensive drugs, the best therapeutic approach should start with the stratification of cardiovascular risk, and contextualized modification of life habits. In this view, the present study aims to evaluate the effectiveness of diet change and other non-pharmacological treatments oriented to reduce the blood pressure in adults diagnosed with prehypertension, hypertension, and resistant hypertension. Therefore, it includes the analysis of these 3 groups: i. pre-hypertension (to evaluate strategies adopted as primary prevention); ii. hypertension in general (to assess blood pressure control and reduce cardiovascular risk reduction), and iii. resistant hypertension (individuals using 3 or more drugs without blood pressure control who have more endothelial dysfunction and target organ damage to assess secondary and tertiary prevention with possible blood pressure control, reduction in the number of drugs in use and subclinical lesions regression). Non-pharmacological approach includes adoption of healthy lifestyles, weight loss, reduced sodium intake, regular physical activity, and integrative practices capable of maintaining biopsychosocial balance. Since those interventions seems to be the best way to reach blood pressure control, we intend to use individual interventions and group actions to increase the population's adherence contributing effectively to public policies within primary care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals of both sexes aged between 20 and 65 years old;
  • Resistant hypertensive individuals: hypertensive individuals using 3 antihypertensive drugs or more without control of office blood pressure (BP ≥ 140 x 90 mmHg) or using 4 drugs with pressure control in follow-up at Hypertension Program (ProHArt) - University Hospital (HUCFF) - Federal University of Rio de Janeiro (UFRJ).
  • Pre-hypertensive individuals: individuals with systolic blood pressure (SBP) between 121-139 mmHg and / or diastolic blood pressure (DBP) between 81-89 mmHg without the use of antihypertensive drugs registered at Family Health Strategy unit.
  • Hypertensive: individuals with SBP ≥ 140 mmHg and / or DBP ≥ 90 mmHg or using antihypertensive drugs registered at Family Health Strategy unit.
  • Individuals who accept to participate in the research after signing the Free and Informed Consent Form

排除标准

  • Pregnant;
  • Major cardiovascular events (acute myocardial infarction, unstable angina, stroke) in the last 6 months;
  • Individuals with psychiatric illnesses or significant cognitive impairment;
  • Individuals with clinical conditions that preclude physical activity such as severe peripheral arterial disease, advanced osteoarticular disease, neurological degenerative disease, severe muscle disease;
  • Individuals who have undergone weight loss procedures (diet or medication) in the last 6 months;
  • Individuals who have undergone surgical procedures for weight loss;
  • Individuals who are participating in any other intervention study.

结局指标

主要结局

Blood pressure

时间窗: 21 months

Indicators: Office blood pressure and Home Blood Pressure Monitoring (HBPM) after 6 months of non-pharmacological intervention Goals: Nutritional strategy: reduction of 1 mmHg by reducing each kg of body weight and reducing salt intake reaching \<1.5 g / day with a reduction of 2 to 3 mmHg. Physical activity: reduction of 6 to 8 mmHg in office systolic blood pressure and 4 to 6 mmHg in HBPM with good adherence to moderate aerobic exercise Integrative practices: 4 mmHg reduction in systolic blood pressure

次要结局

  • Body composition(21 months)
  • Body weight(21 months)

研究者

发起方
Hospital Universitário Clementino Fraga Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

ELIZABETH SILAID MUXFELDT

Medical Doctor

Hospital Universitário Clementino Fraga Filho

研究点 (2)

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