Hypertension Circulatory System Difficult to control hypertension
Conditions
Interventions
Current interventions as of 27/03/2019:
Participant's GPs will be randomly allocated to either the intervention or control group by the coordinating centre using computer-generated random number table
for patients under 60 years, increase the ACEI or ARA II
Step 5: The third drug to increase is the remaining drug (CCB, ACEI or ARA II)
Step 6: In the same order, the 3 drugs will be increased to MRD
Sponsors
Primary Care Management of Mallorca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 13/05/2021: 1. Aged 35-75 years old 2. Diagnosed with hypertension 3. Taking 1 or more antihypertensive drugs 4. Systolic and diastolic blood pressure =130/80 mmHg in 24-hour ambulatory blood pressure monitoring 5. Written informed consent Previous inclusion criteria from 27/03/2019 to 13/05/2021: 1. Aged 35-75 years old 2. Diagnosed with hypertension 3. Taking 2 or more antihypertensive drugs 4. Systolic and diastolic blood pressure =130/80 mmHg in 24-hour ambulatory blood pressure monitoring 5. Written informed consent Original inclusion criteria: 1. Aged 35-75 years old 2. Diagnosed with hypertension 3. Taking 3 or more antihypertensive drugs 4. Systolic and diastolic blood pressure =130/80 mmHg in 24-hour ambulatory blood pressure monitoring 5. Written informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 27/03/2019: 1. Pregnancy or breastfeeding 2. Dialysis or with diagnosis of renal failure 3. Myocardial infarction, heart bypass, angioplasty, stroke, peripheral arterial disease, heart failure, advanced liver disease or atrial fibrillation 4. Institutionalized in a socio-health center indefinitely 5. Severe prognosis that makes it impossible to follow-up during study period 6. Chronic ingestion of corticosteroids 7. Albumin >300 mg/24 hours, glomerular filtration 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure, measured at the baseline 12 months after the start of the intervention, carried out by external personnel who remain blind to the group of the patients. A reduction of at least 5 mmHg in systolic pressure at the end of the study will be considered significant. Blood pressure will be measured while the patient is sitting, using a standardized automated sphygmomanometer (OMROM 7 intelli IT) after a 5-minute period of rest. Two blood pressure readings will be taken 1 to 2 minutes apart and the average will be recorded. The width of the cuff will adapt to the perimeter of the arm and placed on the middle third of the arm. The patient must be seated comfortably and without crossing the legs and with the arm resting on a table and placed at the level of the heart. The patient will be relaxed, with the urinary bladder empty and without having previously smoked or ingested stimulating substances. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/05/2021: 1. Percentage of patients who have reached systolic and diastolic blood pressure levels considered to be under control (< 140/90 mm Hg) after 6 months, assessed as per primary outcome measure 2. Quality of life, assessed using the EuroQol-5D questionnaire at the baseline and after 6 months 3. Proportion of people showing a significant reduction in baseline cardiovascular risk, assessed using the REGICOR risk score at the baseline and after 6 months 4. Adherence to the hypertensive medication, assessed using MPR "Medication Possession Ratio" of the antihypertensive medication registered in the electronic prescription of the patient's medical record, assessed after 6 months 5. Body mass index, assessed by dividing weight in kg by height in metres at the baseline, and after 6 months 6. Physical exercise, assessed using the International Physical Activity Questionnaire (IPAQ) at the baseline and after 6 months 7. Safety of the proposed intervention: 7.1. Percentage of patients with hypertensive crises, assessed by a clinical record review after 6 months 7.2. Number of episodes of hypotension, assessed by a clinical record review after 6 months 7.3. Hypotension requiring visits to the emergency room, assessed by a clinical record review after 6 months 7.4. Adverse effects related to antihypertensive medication, recorded by the GP at each visit and by a clinical record review after 6 months Previous secondary outcome measures: 1. Percentage of patients who have reached systolic and diastolic blood pressure levels considered to be under control (< 140/90 mm Hg) after 12 months, assessed as per primary outcome measure 2. Quality of life, assessed using the EuroQol-5D questionnaire at the baseline and after 12 months 3. Proportion of people showing a significant reduction in baseline cardiovascular risk, assessed using the REGICOR risk score at the baseline and after 12 months 4. Adherence to the hypertensive medication, | — |
Countries
Spain
Contacts
Public ContactFabian Unda Villafuerte
Outcome results
None listed