NCT03180593

Efficacy and Safety of Valsartan and Nebivolol/Valsartan in Hypertensive Patients With LVH

A Prospective, Randomized, Open-Label, 13 to 14-week Study of the Efficacy and Safety of Valsartan and Nebivolol/Valsartan in Hypertensive Subjects With Left Ventricular Hypertrophy (LVH)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Trinity Hypertension & Metabolic Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To assess the efficacy of Left Ventricular Hypertrophy (LVH) reduction and 24-hour blood pressure control of Valsartan 80mg or Nebivolol/Valsartan 5/80mg once daily as replacement therapy for currently treated or untreated hypertensive patients with LVH not at BP goal.

Detailed description

The potential benefits of blood pressure reduction have been demonstrated in numerous large clinical trials. The most recent is the SPRINT Trial demonstrating that lower blood pressure goals can be achieved and are associated with a significant decrease in morbidity and mortality. The latest NHANES 2012 data reveal that less than 50% of patients that are aware of the elevated blood pressure and are being treated achieve blood pressure control. Treatment of hypertension in many patients (\>70%) require treatment with more than one drug, increasing the likelihood of non-compliance and not achieving blood pressure goal. JNC 8 recommends the utilizing of combination therapy both for Stage I and Stage II Hypertensive patients. Objectives of the study to assess the efficacy of LVH reduction and 24-hour blood pressure control of Valsartan 80mg and Nebivolol/Valsartan 5/80mg, once daily for the treatment of currently treated hypertensive patients with LVH. The study will evaluate LVH reduction at 4 and 8 weeks as well as change from baseline in mean 24 hour ABPM SBP after 4 and 8 weeks of treatment with valsartan 80mg or nebivolol/valsartan 5/80mg

Conditions

• Hypertension Complicated
• Hypertrophy, Left Ventricular
• Blood Pressure

Interventions

Type	Name	Description
DRUG	Valsartan 80 mg	Compare office and 24-hour Blood Pressure Control and regression of Left Ventricular Hypertrophy

Timeline

• Start date: 2017-02-07
• Primary completion: 2018-01-25
• Completion: 2018-01-25
• First posted: 2017-06-08
• Last updated: 2018-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study