Clinical trial NCT04746118: Diet and Other Non Pharmacological Interventions to Reduce Cardiovascular Risk in Hypertensive Patients
Official title: Effectiveness of Nutritional Intervention Alone or Associated With Other Non-pharmacological Interventions in Controlling Hypertension and Reducing Cardiovascular Risk - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Resistant hypertension
Diet changes
Regular physical activity
Integrative practices
Pre-hypertension
Lead sponsor: Hospital Universitário Clementino Fraga Filho
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2021-02-09
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Besides the control group (n=60), three other groups with different severity of hypertension will be included in the study. To evaluate strategies adopted as primary prevention 60 pre-hypertensive patients will be recruited. To evaluate blood pressure control and cardiovascular risk reduction, other 60 hypertensives will be also invited to the study. Finally, 60 individuals with resistant hypertension will be recruited to access secondary and tertiary prevention with possible blood pressure control, reduction in the number of drugs in use and subclinical lesions regression.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Blood pressure
timeFrame: 21 months
Secondary outcomes:
measure: Body weight
timeFrame: 21 months
measure: Body composition
timeFrame: 21 months
Other outcomes:
measure: Glycidic profile
timeFrame: 21 months
measure: Lipidic profile
timeFrame: 21 months
measure: Triglycerides
timeFrame: 21 months
measure: Left ventricular hypertrophy
timeFrame: 21 months
measure: Renal function
timeFrame: 21 months
measure: Albuminuria
timeFrame: 21 months
measure: Aortic stiffness
timeFrame: 21 months
measure: Endothelial dysfunction
timeFrame: 21 months
measure: Improved quality of life
timeFrame: 21 months
measure: Obstructive Sleep Apnea (OSA) risk
timeFrame: 21 months
measure: Excessive daytime sleepiness
timeFrame: 21 months
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
Study officials:
affiliation: Hospital Universitário Clementino Fraga Filho
name: Elizabeth S. Muxfeldt, PhD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
citation: Schwingshackl L, Chaimani A, Hoffmann G, Schwedhelm C, Boeing H. Impact of different dietary approaches on blood pressure in hypertensive and prehypertensive patients: protocol for a systematic review and network meta-analysis. BMJ Open. 2017 Apr 26;7(4):e014736. doi: 10.1136/bmjopen-2016-014736.
citation: Pascoe MC, Thompson DR, Jenkins ZM, Ski CF. Mindfulness mediates the physiological markers of stress: Systematic review and meta-analysis. J Psychiatr Res. 2017 Dec;95:156-178. doi: 10.1016/j.jpsychires.2017.08.004. Epub 2017 Aug 23.
citation: Lopes S, Mesquita-Bastos J, Alves AJ, Ribeiro F. Exercise as a tool for hypertension and resistant hypertension management: current insights. Integr Blood Press Control. 2018 Sep 20;11:65-71. doi: 10.2147/IBPC.S136028. eCollection 2018.