Erectile Dysfunctions, Hypertension, Ventricular Remodeling
Conditions
Brief summary
Patients with slight increase in blood pressure levels have an increased cardiovascular risk. In particular this has been demonstrated also in subjects with high-normal blood pressure in whom an exaggerated blood pressure increase, during exercise, and structural left ventricular abnormalities have been shown. On the other hand, the last American and European guidelines for management of hypertension recommend more aggressive treatment in young-middle aged subjects to achieve a better control of cardiovascular risk due to blood pressure increase. In agreement with these recommendations the investigators share the idea that a good blood pressure control should be achieved not only at rest, but also during psycho-physical stress conditions that frequently occur during daily life. On this basis, the investigators decided to evaluate the efficacy and tolerability of the association of valsartan and hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood pressure and first degree arterial hypertension with evidence of organ damage. The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage without interfering with metabolism and erectile function
Interventions
DRUGValsartan 160mg plus HCT 25mg
valsartan 160 mg once a day for 6 months plus hydrochlorothiazide 25 mg a tablet once a day for 6 months
Sponsors
Federico II University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-65 * Gender Males * High-normal blood pressure (130-139 mmHg or 85-89 mmHg) * First degree hypertension (140-159 mmHg or 90-99 mmHg) * Cardiac remodeling (left ventricular concentric hypertrophy
Exclusion criteria
* Coronary artery disease * Secondary hypertension * Diabetes mellitus * Incapacity to perform ergometry test * Anemia (Hb \< 12.5g/dL) * Cardiac valve disease * Arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage assessed by bicycle stress test and mono-bidimensional echocardiography. | 3 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Effects of Valsartan 160mg / HCT 25mg on metabolism and erectile function | 3 and 6 months |
Countries
Italy
Outcome results
None listed