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

NCT01961323 | Completed Phase 4 Results DMC

• 1 other identifier: GCO 12-0493
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Left Ventricular Diastolic Dysfunction

Keywords

Hypertension; high blood pressure; stress echocardiogram; nebivolol; left ventricular diastolic dysfunction

Outcome Measures

Primary Outcomes (1)

• Improvement in Exercise Tolerance

  measured by stress echocardiogram, number of participants who had improvement in METS and improvement in exercise time as compared to their baseline.

  at 6 months

Secondary Outcomes (2)

• E Velocity Indexed to e' (E/e' Ratio) of the Left Ventricle

  at 6 months

• Untwist Rate of the Left Ventricle

  at 6 months

Study Arms (1)

Nebivolol

EXPERIMENTAL

Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months

Drug: Nebivolol

Interventions

Nebivolol DRUG

Doses will be titrated based on weekly visits during the first 2 weeks to achieve a target SBP\<140 and DBP \<90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic.

Nebivolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \<50 mL/min
• Terminal Illness with expected Survival of \<1 year
• Previous Heart Transplant
• Individuals who are institutionalized
• Systolic BP\>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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Forest Laboratories: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Hypertension; Ventricular Dysfunction, Left

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Partho Sengupta
• Organization: Icahn School of Medicine at Mount Sinai

partho.sengupta@mountsinai.org

212-659-8847

Study Officials

• Partho Sengupta, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: March 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 24, 2017
• Results First Posted: November 24, 2017

Record last verified: 2017-10

Locations

US (1)