NCT05170061

24 Hour Ambulatory Cardiac Oxygen Consumption

Ambulatory 24-Hour Cardiac Oxygen Consumption and Blood Pressure-Heart Rate Variability: Effects of Nebivolol and Valsartan Alone and in Combination

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized,double-blind, active controlled,15 week study to evaluate the effects of nebivolol and valsartan alone and in combination on 24-hour ambulatory cardiac work and variability of heart rate-mean central systolic pressure product.

Detailed description

Subjects with hypertension (systolic blood pressure (SBP) \>140 or diastolic blood pressure (DBP)\>90, n=26) were studied using a double-blinded, forced-titration, sequence-controlled, crossover design with 3 experimental periods: Valsartan 320, nebivolol 40, and nebivolol/valsartan 320/40 mg daily. After 4 weeks of each drug, ambulatory pulse wave analysis (IEM MobilOGraph) was performed every 20 min for 24-hours. The primary hypothesis was that nebivolol/valsartan combination therapy would be superior to valsartan monotherapy in reducing mean 24-hour mean myocardial oxygen consumption determined by 24-hour ambulatory heart rate-central systolic pressure product \[ACRPP\]. A secondary hypothesis was that the combination would also reduce the variability of 24-hour myocardial oxygen consumption.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Nebivolol	Nebivolol 20 mg daily (1 week) followed by nebivolol 40 mg daily (3 weeks) followed by nebivolol 20 mg daily (1 week)
DRUG	Valsartan	Valsartan 160 mg daily (1 week) followed by valsartan 320 mg daily (3 weeks) followed by valsartan 160 mg daily (1 week).
DRUG	Nebivolol/valsartan combination	Valsartan/Nebivolol, 160/20 mg daily (1 week) followed by valsartan/nebivolol 320/40 mg daily (3 weeks) followed by valsartan/nebivolol 160/20 mg daily (1 week)

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2021-12-27
• Last updated: 2025-06-08
• Results posted: 2025-06-08

Locations

1 site across 1 country: United States