Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 1 or more antihypertensive drugs: the MEDICHY study

Not Applicable

Completed

Conditions: Hypertension
Circulatory System
Difficult to control hypertension

Registration Number: ISRCTN14433778

Lead Sponsor: Primary Care Management of Mallorca

Brief Summary: 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32332617/ (added 21/11/2023) 2024 Results article in https://doi.org/10.3389/fcvm.2024.1355037 (added 05/06/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 350

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

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 < 45 ml/min1,73 m2

Previous exclusion criteria:
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 NSAIDs or corticosteroids
7. Albumin/creatinine ratio > 1