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

NCT03180593 | Completed Phase 4 FDA Drug

• 1 other identifier: BYS-IT-78
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension Complicated; Hypertrophy, Left Ventricular; Blood Pressure

Outcome Measures

Primary Outcomes (2)

• LVH reduction at 4 weeks.

  Reduction of Left ventricular hypertrophy from baseline compared to 4 weeks of treatment

  4 weeks

• 24hr-ABPM measurement Change from baseline in mean 24 hour ABPM SBP

  Reduction of Systolic BP over 24 hours baseline compared to 4 weeks of treatment

  4 weeks

Secondary Outcomes (4)

• LVH reduction at 8 weeks.

  8 weeks

• 24hr-Systolic ABPM measurement

  8 weeks

• 24hr- DBP ABPM measurements

  4 and 8 weeks

• Office Blood Pressure measurements

  4 and 8 weeks

Study Arms (2)

Valsartan Arm

ACTIVE COMPARATOR

Valsartan 80mg randomly assigned for 8 weeks to asses BP control with office and 24-hour ABPM and reduction of LVH

Drug: Valsartan 80 mg

Nebivolol/Valsartan

ACTIVE COMPARATOR

Nebivolol/Valsartan 5/80mg randomly assigned for 8 weeks to asses Blood Pressure control with office and 24-hour Ambulatory Blood Pressure Monitoring and reduction of Left Ventricular Hypertrophy

Drug: Valsartan 80 mg

Interventions

Valsartan 80 mg DRUG

Compare office and 24-hour Blood Pressure Control and regression of Left Ventricular Hypertrophy

Also known as: Nebivolol/Valsartan 5/80mg

Nebivolol/Valsartan; Valsartan Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of reading, comprehending the consent process and providing written informed consent to participate in the study.
• Male or female ≥ 18 years of age who are either newly diagnosed with HTN or who are currently being treated.
• Patients must have a mean cuff sitting diastolic blood pressure cuff (DBP) \> 90 mmHg and \<105 mmHg (\< 100 mmHg on prior treatment) and mean cuff sitting systolic blood pressure (SBP) \<160 mmHg, at two consecutive qualifying visits during the placebo run in period.
• Arm circumference \< 45cm.
• Compliance with single blind placebo capsules between V1 to 4 or 4X of 80-120%.
• Women may be enrolled if the following criteria are met:
• Have a negative serum pregnancy test at screening 2.- Are not breastfeeding 3.- Do not plan to become pregnant during the study 4.- Have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form or 5.- Have been postmenopausal for at least 1 year or 6. - If they are of childbearing potential and will practice one of the following methods of birth control throughout the study: oral, patch, injectable, or implantable hormone contraception, intrauterine device, diaphragm plus spermicide or female condom plus spermicide. Abstinence, partner's vasectomy are not acceptable methods of contraception.
• \. Diagnosis of Left Ventricular Hypertrophy (LVH).

You may not qualify if:

• Known allergy or hypersensitivity to Beta-Blockers.
• Known allergy or hypersensitivity to Angiotensin II Receptor Blockers.
• Patients with severe hypertension (mean seated cuff DBP\>115 mmHg or mean seated SBP\> 180mmHg) or any form of secondary hypertension.
• Patients within the past 6 months with a history of hypertensive encephalopathy, stroke or transient ischemic attack.
• Patients within the last 6 months with a history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary bypass graft, valvular surgery or unstable angina.
• Patients with evidence of resting bradycardia (\<50 bpm) via palpation.
• Patients with a history of heart block greater than First Degree Sino-atrial Block. Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial Fibrillation, Atrial Flutter, Congestive Heart Failure, or other manifestations of clinically significant cardiac valvular disease.
• Patients with hemodynamically significant cardiac valvular disease.
• Patients with evidence of significant chronic renal impairment as indicated by a serum creatinine of \> 2.5mg/dL.
• Patients with evidence of liver disease as indicated by AST (SGOT) or ALT (SGPT) \> 2.5 times or total bilirubin \> 1.5 times, the upper limit of the laboratory normal range.
• Patients who demonstrate other laboratory test values deviating from the normal range which are considered to be clinically significant by the investigator.
• Patient with a history or presence of gastrointestinal disease which may interfere with drug absorption.
• Patients with insulin and non-insulin dependent diabetes mellitus not controlled on diet, insulin, or oral hypoglycemics as defined by a HgA1c \>10.
• Severe psychological or emotional condition which may interfere with participation in the study.
• History of or current use of illicit drugs or alcohol abuse.

Sponsors & Collaborators

• Trinity Hypertension & Metabolic Research Institute: lead
• Allergan Sales, LLC: collaborator

Study Sites (1)

Trinity Hypertension & Metabolic Research Institute

Carrollton, Texas, 75006, United States

Location

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Interventions

Valsartan; Nebivolol

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Henry A Punzi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: alternating
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Model Details: Prospective, randomized, open label, blinded-endpoint (PROBE)

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: February 7, 2017
• Primary Completion: January 25, 2018
• Study Completion: January 25, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)