Phase 4 N=70 Treatment

Effect of Nebivolol on the Blood Flow in Hearts of Adults With High Blood Pressure and Abnormal Filling of Heart

Hypertension · Left Ventricular Diastolic Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT01961323 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2017

Primary outcome: Primary: Improvement in Exercise Tolerance — 9; 8 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nebivolol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Improvement in Exercise Tolerance	9; 8	—
SECONDARY E Velocity Indexed to e' (E/e' Ratio) of the Left Ventricle	7.5; 8.8	—
SECONDARY Untwist Rate of the Left Ventricle	—	—

Summary

To investigate whether treatment with Nebivolol in subjects with high blood pressure and abnormal filling of left ventricle (LVDD) improves exercise time by improving Left Ventricular deformation and filling.

Eligibility Criteria

Inclusion Criteria

History of mild (140-160 / 90-100) to moderate (160-200 / 100-120) hypertension
LV diastolic dysfunction (>/= Grade1)
LV ejection fraction >50%
Indexed left atrial volume >/= 28 mL/m^2
In sinus rhythm at the time of enrollment
Willingness to return for the 6-month follow up investigations

Exclusion Criteria

Presence or history of any of the following at baseline:
History of mitral valve disease of greater than mild severity or prosthetic mitral valve, congenital heart disease or permanent pacemaker
Calculated creatinine clearance 180 mm Hg or diastolic BP > 120 mm Hg
Medical treatment for elevated BP with:
Calcium channel blocker (e.g. verapamil, nifedipine);
Alpha blocker (e.g. prazosin);
Alpha agonist (e.g. α-methyldopa, hydralazine, clonidine)
Patient unwilling or unable to provide informed consent for study participation
Pregnancy (current, or anticipated within the study period)
Secondary Hypertension
Previous echo contrast allergy
Poor echocardiography window
Previous stroke, known carotid stenosis
Contraindication for beta-blocker therapy (sinus bradycardia twice above normal levels)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01961323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.