An interventional study of Home Blood Pressure Monitoring in Hypertension, sponsored by Universidade Federal do Ceara. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Universidade Federal do Ceara · Not applicable, Interventional, and Supportive care
Among 208 studies in Hypertension with a site in Brazil — 31 open to participants now, 35 under way, 6 of them phase 3. Hypertension · Brazil.
Among the 208 studies in Hypertension with a site in Brazil, this one is the 100th largest by enrollment of the 189 interventional ones, is one of 9 that started in 2022, is one of 112 with no phase, and was the 188th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 70 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →31 of the 208 studies in Hypertension with a site in Brazil are open now, in 12 countries. Each count lists the studies.
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →208 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 9 started in 2022.
Median enrollment 80 across the 189 interventional studies, 124 across the 17 observational. Of the 134 that completed or were terminated, 20 (15%) have results posted.
37 of 208 have an industry lead sponsor. The 10 most frequent:
Universidade Federal do Ceara is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Universidade Federal do Ceara has 1 study filed under Hypertension — fewer than ten, so there is no comparison to draw.
19 of the studies in Hypertension with a site in Brazil that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT07361276AstraZenecaObservational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care System | 2026-11-30 |
| NCT07058922National Institute of Cardiology, Laranjeiras, BrazilAcute Effects of Powdered Beetroot Extract Supplementation on the Microcirculation of Resistant Hypertensive Individuals | 2026-12 |
| NCT06105775University of Sao PauloInorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies | 2026-12 |
| NCT06169241National Institute of Cardiology, Laranjeiras, BrazilEffect of Nitrate Supplementation on Blood Pressure and Microvascular Function of Resistant Hypertensive Patients | 2026-12 |
Among the 208 studies in Hypertension with a site in Brazil, from their registry updates:
This study aimed to test Home Blood Pressure Monitoring (HBPM) in reducing blood pressure (BP) levels in individuals with uncontrolled hypertension. Data collection was conducted in 5 stages: 1) recruitment; 2) inclusion in the study and collection of baseline data, including information on sociodemographic issues, anthropometric and clinical profile, and adherence to medication treatment; 3) randomization; 4) intervention; and 5) Reassessment of adherence to medication treatment. All participants will be monitored by the research team in three follow-up visits at the unit. The intervention consisted of HBPM being performed by participants in the IG, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month. Participants in the CG did not perform HBPM, but were also monitored by the research team in their follow-up visits. In these follow-up visits, for both groups, the researchers performed new BP measurements using the oscillometric method.
The outcome was the reduction in mean SBP and DBP values over time within and between groups, consisting of a reduction with a significant difference between the baseline and the post-intervention period.
The Omron HEM-1100® automatic clinical monitor was used to perform oscillometric BP measurement in the unit.
The HEM 7122 automatic BP monitor was made available to IG participants for self-measurement of BP at home. The following were included:
Inclusion criteria: a) Patients diagnosed with hypertension, whether or not associated with DM, CAD or RI; b) Time since diagnosis greater than 6 months; c) BP > 140/90 mmHg obtained in triplicate during the initial clinical consultation conducted by the researchers, immediately after the invitation to participate in the study; d) Having been following the same antihypertensive drug treatment for at least 4 weeks, according to the participant's self-report; e) Having mobility conditions to attend follow-up consultations at the health unit.
Exclusion Criteria: a) Pregnant women or women actively seeking to become pregnant; b) Have physical incapacity (represented by the presence of tetraplegia, tetraparesis, triplegia, triparesis, hemiplegia, hemiparesis, amputation or cerebral palsy), cognitive incapacity (represented by the presence of dementia, depression, delirium and mental illnesses, such as schizophrenia, oligophrenia and paraphrenia), and have undergone surgical procedures, accidents, amputation, oncological treatment that prevents self-monitoring of BP; c) Inability to maintain the monitor at home, represented by the participant's refusal to receive and/or keep the device; d) Acute cardiovascular event (myocardial infarction and stroke) in the last three months; e) Have a medical diagnosis of arrhythmia, as per the participant's self-report and confirmation in the medical record. f) Perform home BP measurement, represented by the participant's report. -
The intervention consisted of HBPM being performed by IG participants, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month.
Procedure: Home Blood Pressure Monitoring
The intervention consisted of HBPM being performed by IG participants, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month.
Reduction in average Systolic and Diastolic Blood Pressure values
Reduction in mean SBP and DBP values over time within and between groups, consisting of a reduction with a significant difference between the baseline and the post-intervention period.
Time frame: 9 months
Plan to share: Yes — all collected IPD
Supporting information: Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data de inicio ainda não foi prevista
Access criteria: Those who request
No publications or documents are linked to this record.
Ran from Dec 2022 to primary completion in Sep 2023, 9 months.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 9 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Universidade Federal do Ceara