Blood Pressure, High
Conditions
Brief summary
This trial is designed to: 1. Assess the response to montherapy with : a thiazide diuretic (HCTZ), a calcium-channel blocker (CCB, amlodipine) and an angiotensin-receptor blocker (telmisartan), among hypertensive subjects who live at sea level, at medium altitude above sea level and at high altitude above sea level. 2. To test whether diferentes exist in the response to therapy among subjects who live at different altitude above sea level 3. To assess the hemodynamic characteristics of hypertension in populations that live at sea level, at medium altitude above sea level, and at high altitude above sea level.
Interventions
DRUGTelmisartan
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
DRUGHydrochlorothiazide
Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
DRUGAmlodipine
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Sponsors
Prevencion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 45-75 years. Enrollment will be stratified by age group (50-65 and 66-80 years), gender and altitude above sea level 2. Leaving in the enrollment cities for at least 2 years 3. Untreated hypertension for at least 2 weeks 4. Systolic BP between 140 and 160 mmHg and/or diastolic BP between 90 and 99 mmHg, in the absence of therapy.
Exclusion criteria
1. Diabetes mellitus. 2. Chronic kidney disease (estimated glomerular filtration rate \<60 ml / minute / 1.73 m2 of body surface area. 3. Smoking. 4. Lung disease, liver disease or active cancer 5. Any factor that, in the opinion of the investigator, decreases short-term survival 6. Psychiatric illness 7. Inability to provide informed consent 8. Established heart disease (previous myocardial infarction, heart failure, valvular heart disease, cardiomyopathy, atrial fibrillation or any significant cardiac arrhythmia) 9. History of cerebrovascular disease 10. History of orthostatic hypotension. 11. History of syncope. 12. History of allergy of adverse effects to study medications or drugs of the same pharmacologic classes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks | 4 weeks |
| Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks | 4 weeks |
| Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks | 4 weeks |
| Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks | 4 weeks |
| Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks | 4 weeks |
Countries
Peru
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Hydrochlorothiazide: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM | 56 |
| Calcium-channel Blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Amlodipine: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM | 55 |
| Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Telmisartan: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM | 55 |
| Total | 166 |
Baseline characteristics
| Characteristic | Total | Diuretic | Calcium-channel Blocker | Angiotensin Receptor Blocker |
|---|---|---|---|---|
| 24-hour Diastolic Blood Pressure | 78.06 mm Hg STANDARD_DEVIATION 9.07 | 78.22 mm Hg STANDARD_DEVIATION 7.9 | 77.43 mm Hg STANDARD_DEVIATION 9.56 | 78.52 mm Hg STANDARD_DEVIATION 9.78 |
| 24-hour Mean Arterial Pressure | 100.81 mm Hg STANDARD_DEVIATION 9.51 | 101.02 mm Hg STANDARD_DEVIATION 8.28 | 100.04 mm Hg STANDARD_DEVIATION 9.29 | 101.37 mm Hg STANDARD_DEVIATION 10.93 |
| 24-hour Pulse Pressure | 49.67 mm Hg STANDARD_DEVIATION 9.26 | 49.76 mm Hg STANDARD_DEVIATION 8.6 | 49.37 mm Hg STANDARD_DEVIATION 7.87 | 49.88 mm Hg STANDARD_DEVIATION 11.15 |
| 24-hour Systolic Blood Pressure | 127.73 mm Hg STANDARD_DEVIATION 12.13 | 127.98 mm Hg STANDARD_DEVIATION 10.8 | 126.80 mm Hg STANDARD_DEVIATION 10.65 | 128.40 mm Hg STANDARD_DEVIATION 14.69 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 62 Participants | 23 Participants | 20 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 104 Participants | 33 Participants | 35 Participants | 36 Participants |
| Age, Continuous | 59.87 years STANDARD_DEVIATION 9 | 58.32 years STANDARD_DEVIATION 10.06 | 60.95 years STANDARD_DEVIATION 8.35 | 60.38 years STANDARD_DEVIATION 8.41 |
| Carotid-Femoral Pulse Wave Velocity | 8.40 meters/second | 8.70 meters/second | 8.20 meters/second | 8.35 meters/second |
| Carotid Pulse Pressure | 54.00 mm Hg | 53.50 mm Hg | 53.00 mm Hg | 55.00 mm Hg |
| Diastolic blood pressure, office | 85.82 mm Hg STANDARD_DEVIATION 9.5 | 84.41 mm Hg STANDARD_DEVIATION 7.27 | 86.7 mm Hg STANDARD_DEVIATION 12.01 | 86.38 mm Hg STANDARD_DEVIATION 8.63 |
| Region of Enrollment Peru | 166 participants | 56 participants | 55 participants | 55 participants |
| Sex: Female, Male Female | 86 Participants | 28 Participants | 29 Participants | 29 Participants |
| Sex: Female, Male Male | 80 Participants | 28 Participants | 26 Participants | 26 Participants |
| Systolic blood pressure, office | 144.83 mm Hg STANDARD_DEVIATION 9.92 | 144.68 mm Hg STANDARD_DEVIATION 9.63 | 143.62 mm Hg STANDARD_DEVIATION 9.52 | 146.2 mm Hg STANDARD_DEVIATION 10.59 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 56 | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 56 | 0 / 55 | 0 / 55 |
Outcome results
Primary
Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diuretic | Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks | -5.9 mmHg | Standard Deviation 8.4 |
| Calcium-channel Blocker | Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks | -7.5 mmHg | Standard Deviation 9.2 |
| Angiotensin Receptor Blocker | Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks | -8.4 mmHg | Standard Deviation 8.8 |
Secondary
Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diuretic | Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks | -3.5 mmHg | Standard Deviation 5.7 |
| Calcium-channel Blocker | Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks | -4.7 mmHg | Standard Deviation 5.5 |
| Angiotensin Receptor Blocker | Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks | -5.6 mmHg | Standard Deviation 6.2 |
Secondary
Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diuretic | Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks | -4.6 mmHg | Standard Deviation 6.5 |
| Calcium-channel Blocker | Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks | -6.0 mmHg | Standard Deviation 6.9 |
| Angiotensin Receptor Blocker | Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks | -6.9 mmHg | Standard Deviation 7.1 |
Secondary
Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diuretic | Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks | -2.4 mmHg | Standard Deviation 5.4 |
| Calcium-channel Blocker | Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks | -2.8 mmHg | Standard Deviation 5.6 |
| Angiotensin Receptor Blocker | Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks | -2.8 mmHg | Standard Deviation 4.9 |
Secondary
Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diuretic | Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks | -0.4 m/sec | Standard Deviation 1.3 |
| Calcium-channel Blocker | Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks | -0.3 m/sec | Standard Deviation 1.3 |
| Angiotensin Receptor Blocker | Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks | -0.6 m/sec | Standard Deviation 2 |
Secondary
Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diuretic | Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks | -11.6 mmHg | Standard Deviation 15.6 |
| Calcium-channel Blocker | Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks | -9.6 mmHg | Standard Deviation 18.7 |
| Angiotensin Receptor Blocker | Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks | -11.2 mmHg | Standard Deviation 14.2 |