Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage

Phase 4

Completed

• Conditions: Hypertension; Ventricular Remodeling; Erectile Dysfunctions
• Interventions: Drug: Valsartan 160mg plus HCT 25mg

• Registration Number: NCT00687206
• Lead Sponsor: Federico II University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-05
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-28
• Last Update Posted: 2009-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Valsartan 160mg plus HCT 25mg	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Effects of Valsartan 160mg / HCT 25mg on metabolism and erectile function	3 and 6 months

Trial Locations

Locations (1)

Department of internal medicine University Federico II; 🇮🇹 Naples, Italy