Diet and Other Non Pharmacological Interventions to Reduce Cardiovascular Risk in Hypertensive Pa… (NCT04746118) | Clinical Trial Compass
UnknownNot Applicable
Diet and Other Non Pharmacological Interventions to Reduce Cardiovascular Risk in Hypertensive Patients
Brazil240 participantsStarted 2021-04
Plain-language 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.
Who can participate
Age range
20 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood pressure
Timeframe: 21 months
Trial details
NCT IDNCT04746118
SponsorHospital Universitário Clementino Fraga Filho