HypertensionPhase 4NCT01502787

Comparison of Nebivolol and Metoprolol With Exercise and Angiotensin II in Hypertensive Patients

A Phase 4 study testing Metoprolol succinate, Nebivolol and Forearm blood flow in people with Hypertension, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine if Nebivolol a) attenuates the angiotensin II (Ang II)-induced increase in oxidative stress, thereby attenuating Ang II-induced vasoconstriction; and b) attenuates sympathetic mediated vasoconstriction during exercise, thereby reducing functional skeletal muscle ischemia in… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hypertension
What is being tested?: Metoprolol succinate, Nebivolol and Forearm blood flow
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: Apr 2009to Jun 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Stage I hypertension (140-159/90-99 mmHg)
Men and women age 18-65

Who cannot join

Congestive heart failure or coronary artery disease
Blood pressure averaging >159/99 mmHg or resting heart rate < 55 bpm
Serum creatinine > 1.4 mg/dL
Asthma or chronic obstructive pulmonary diseases
Left ventricular hypertrophy by echocardiography or ECG
Pregnancy

Show all 10Show fewer

Hypersensitivity to beta blockers, microbubble contrast agents, or angiotensin
Any history of substance abuse (other than tobacco)
Concomitant drug treatment which raises endogenous nitric oxide levels such as nitrates or phosphodiesterase V inhibitors (Viagra, Levitra, or Cialis)
History of symptomatic bradycardia or heart block

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

Official title: Effects of Nebivolol Versus Metoprolol on Blood Flow Responses to Exercise and Angiotensin II in Hypertensive Patients

Read the detailed description

In 40 untreated, stage I hypertensive subjects, Investigators will measure sympathetic nerve activity (microneurography); total forearm blood flow (high-resolution ultrasonography); skeletal muscle oxygenation (Near Infrared spectroscopy); plasma F2-isoprostanes; cardiac output (non-invasive impedance plethysmography); and blood pressure at baseline and after a) rhythmic handgrip exercise at 30% of maximal voluntary contraction alone for 3 minutes, b) rhythmic handgrip at the same intensity of exercise plus lower body negative pressure (LBNP) to activate sympathetic nerve activity (SNA) for 2 minutes, and c) during intravenous infusion of Angiotensin II at the dose of 1, 2, and 3 ng/kg/min for 15 minutes at each dose.

Each subject will then be randomized to receive 12 weeks of Nebivolol (Bystolic, 5-20 mg/day) or Metoprolol Succinate (Toprol XL, 100-300 mg/day), using a randomized crossover design. There will be a 2-week washout period between the two treatment periods. During drug treatment, blood pressure will be monitored every 4 weeks and the doses of Nebivolol and Metoprolol will be titrated to keep BP <140/90 mmHg. SNA, total forearm blood flow, skeletal muscle blood flow, muscle oxygenation, cardiac output, and blood pressure responses to Nebivolol will be compared to responses during Metoprolol in the same subjects.

Conditions: Hypertension
Being tested: Metoprolol succinate, Nebivolol, Forearm blood flow, Microneurography, Rhythmic handgrip exercise
Keywords: hypertension, blood pressure, blood pressure medications, metoprolol, nebivolol, handgrip exercise, lower body negative pressure, angiotensin II, sympathetic nerve activity, flow mediated dilation, nitric oxide, microneurography
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Metoprolol succinateDrug
Also called Toprol XL
The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
NebivololDrug
Also called Bystolic
The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
Forearm blood flowProcedure or surgery
Using high-resolution ultrasound, investigators will measure skeletal muscle blood flow in the forearm at rest, following handgrip exercise (described below), and following Angiotensin II infusion (described below).
MicroneurographyProcedure or surgery
Also called Assessment of sympathetic nerve activity (SNA)
Investigators will measure sympathetic nerve activity from the peroneal nerve by inserting a tiny needle directly into the nerve in the leg. Investigators will localize the nerve by electrical stimulation over the skin using a blunt probe. With this stimulation, subject will notice either involuntary twitching or a tingling sensation, which may be annoying but not painful. Investigators will then introduce a tiny, sterile wire needle (an electrode) through the skin at the same location. When the tip of the needle enters the nerve, subjects may again notice involuntary muscle twitches or tingling in the leg. Investigators will then turn the electrical stimulator off and make minor adjustments in the position of the needle until investigators begin to record the nerve signals. The recording needle will remain in position throughout the study.
Rhythmic handgrip exerciseProcedure or surgery
Subjects will perform a rhythmic handgrip exercise at 30% of maximal voluntary contraction for 3 minutes. Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure, and sympathetic nerve activity (SNA) at baseline and following this handgrip exercise.
Lower body negative pressureProcedure or surgery
Also called LBNP
Lower body negative pressure increases sympathetic nerve activity. Therefore, investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure and sympathetic nerve activity at baseline and after rhythmic handgrip exercise plus lower body negative pressure (LBNP) for 2 minutes.
Angiotensin IIDrug
Also called IND #103,935
Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure and sympathetic nerve activity at baseline and during intravenous infusion of Angiotensin II at the dose of 1, 2, and 3 ng/kg/min for 15 minutes at each dose.

Study groups in NCT01502787
Study group	Role	What they receive
Initial treatment with metoprolol	Active comparator	The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. Receives: Drug: Metoprolol succinate; Drug: Nebivolol; Procedure: Forearm blood flow; Procedure: Microneurography; Procedure: Rhythmic handgrip exercise; Procedure: Lower body negative pressure; Drug: Angiotensin II
Initial treatment with nebivolol	Active comparator	The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. Receives: Drug: Metoprolol succinate; Drug: Nebivolol; Procedure: Forearm blood flow; Procedure: Microneurography; Procedure: Rhythmic handgrip exercise; Procedure: Lower body negative pressure; Drug: Angiotensin II

What is being measured

The primary outcome is the main question the study is designed to answer.

Forearm Blood Flow
Measured: 12 weeks after each specified medication

Secondary outcomes (2)

Blood Pressure During Exercise
Measured: 12 weeks
Blood Pressure During Angiotensin II Infusion
Measured: 12 weeks after initiation of metoprolol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jun 2013

First posted2 Jan 2012 (estimated)
Study startApr 2009
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01502787
Sponsor's protocol ID: STU 062011-072
Status last verified: Jul 2020
First submitted: 1 Nov 2011
Last updated: 7 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rosenmeier JB, Dinenno FA, Fritzlar SJ, Joyner MJ. alpha1- and alpha2-adrenergic vasoconstriction is blunted in contracting human muscle. J Physiol. 2003 Mar 15;547(Pt 3):971-6. doi: 10.1113/jphysiol.2002.037937. Epub 2003 Feb 14.
PubMed 12588902
Hansen J, Sander M, Thomas GD. Metabolic modulation of sympathetic vasoconstriction in exercising skeletal muscle. Acta Physiol Scand. 2000 Apr;168(4):489-503. doi: 10.1046/j.1365-201x.2000.00701.x.
PubMed 10759586
Thomas GD, Sander M, Lau KS, Huang PL, Stull JT, Victor RG. Impaired metabolic modulation of alpha-adrenergic vasoconstriction in dystrophin-deficient skeletal muscle. Proc Natl Acad Sci U S A. 1998 Dec 8;95(25):15090-5. doi: 10.1073/pnas.95.25.15090.
PubMed 9844020
Thomas GD, Zhang W, Victor RG. Impaired modulation of sympathetic vasoconstriction in contracting skeletal muscle of rats with chronic myocardial infarctions: role of oxidative stress. Circ Res. 2001 Apr 27;88(8):816-23. doi: 10.1161/hh0801.089341.
PubMed 11325874
Chavoshan B, Sander M, Sybert TE, Hansen J, Victor RG, Thomas GD. Nitric oxide-dependent modulation of sympathetic neural control of oxygenation in exercising human skeletal muscle. J Physiol. 2002 Apr 1;540(Pt 1):377-86. doi: 10.1113/jphysiol.2001.013153.
PubMed 11927694
Zhao W, Swanson SA, Ye J, Li X, Shelton JM, Zhang W, Thomas GD. Reactive oxygen species impair sympathetic vasoregulation in skeletal muscle in angiotensin II-dependent hypertension. Hypertension. 2006 Oct;48(4):637-43. doi: 10.1161/01.HYP.0000240347.51386.ea. Epub 2006 Aug 28.
PubMed 16940212
Murphey LJ, Morrow JD, Sawathiparnich P, Williams GH, Vaughan DE, Brown NJ. Acute angiotensin II increases plasma F2-isoprostanes in salt-replete human hypertensives. Free Radic Biol Med. 2003 Oct 1;35(7):711-8. doi: 10.1016/s0891-5849(03)00395-2.
PubMed 14583335
Dijkhorst-Oei LT, Stroes ES, Koomans HA, Rabelink TJ. Acute simultaneous stimulation of nitric oxide and oxygen radicals by angiotensin II in humans in vivo. J Cardiovasc Pharmacol. 1999 Mar;33(3):420-4. doi: 10.1097/00005344-199903000-00012.
PubMed 10069678
Vittorio TJ, Lang CC, Katz SD, Packer M, Mancini DM, Jorde UP. Vasopressor response to angiotensin II infusion in patients with chronic heart failure receiving beta-blockers. Circulation. 2003 Jan 21;107(2):290-3. doi: 10.1161/01.cir.0000045666.04794.14.
PubMed 12538430
Oelze M, Daiber A, Brandes RP, Hortmann M, Wenzel P, Hink U, Schulz E, Mollnau H, von Sandersleben A, Kleschyov AL, Mulsch A, Li H, Forstermann U, Munzel T. Nebivolol inhibits superoxide formation by NADPH oxidase and endothelial dysfunction in angiotensin II-treated rats. Hypertension. 2006 Oct;48(4):677-84. doi: 10.1161/01.HYP.0000239207.82326.29. Epub 2006 Aug 28.
PubMed 16940222
Fratta Pasini A, Garbin U, Nava MC, Stranieri C, Davoli A, Sawamura T, Lo Cascio V, Cominacini L. Nebivolol decreases oxidative stress in essential hypertensive patients and increases nitric oxide by reducing its oxidative inactivation. J Hypertens. 2005 Mar;23(3):589-96. doi: 10.1097/01.hjh.0000160216.86597.ff.
PubMed 15716701
Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
PubMed 12748199
Klingbeil AU, Schobel H, Langenfeld MR, Hilgers K, Schaufele T, Schmieder RE. Hyper-responsiveness to angiotensin II is related to cardiac structural adaptation in hypertensive subjects. J Hypertens. 1999 Jun;17(6):825-33. doi: 10.1097/00004872-199917060-00015.
PubMed 10459881
Hopkins PN, Hunt SC, Jeunemaitre X, Smith B, Solorio D, Fisher ND, Hollenberg NK, Williams GH. Angiotensinogen genotype affects renal and adrenal responses to angiotensin II in essential hypertension. Circulation. 2002 Apr 23;105(16):1921-7. doi: 10.1161/01.cir.0000014684.75359.68.
PubMed 11997278
Vuagnat A, Giacche M, Hopkins PN, Azizi M, Hunt SC, Vedie B, Corvol P, Williams GH, Jeunemaitre X. Blood pressure response to angiotensin II, low-density lipoprotein cholesterol and polymorphisms of the angiotensin II type 1 receptor gene in hypertensive sibling pairs. J Mol Med (Berl). 2001 May;79(4):175-83. doi: 10.1007/s001090100205.
PubMed 11409708

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Nebivolol Versus Metoprolol on Blood Flow Responses to Exercise and Angiotensin II in Hypertensive Patients
ClinicalTrials.gov ID: NCT01502787
Acronym / sponsor ID: STU 062011-072
Conditions: Hypertension
Keywords: hypertension, blood pressure, blood pressure medications, metoprolol, nebivolol, handgrip exercise, lower body negative pressure, angiotensin II
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: Forest Laboratories
Study start: Apr 2009
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 2 Jan 2012 (estimated)
Results: Posted 31 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Initial treatment with metoprolol	Active comparator	Drug: Metoprolol succinate, Drug: Nebivolol, Procedure: Forearm blood flow, Procedure: Microneurography, Procedure: Rhythmic handgrip exercise, Procedure: Lower body negative pressure, Drug: Angiotensin IIThe subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
Initial treatment with nebivolol	Active comparator	Drug: Metoprolol succinate, Drug: Nebivolol, Procedure: Forearm blood flow, Procedure: Microneurography, Procedure: Rhythmic handgrip exercise, Procedure: Lower body negative pressure, Drug: Angiotensin IIThe subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Stage I hypertension (140-159/90-99 mmHg)
Men and women age 18-65

Key exclusion criteria (10 listed)

Congestive heart failure or coronary artery disease
Blood pressure averaging >159/99 mmHg or resting heart rate < 55 bpm
Serum creatinine > 1.4 mg/dL
Asthma or chronic obstructive pulmonary diseases
Left ventricular hypertrophy by echocardiography or ECG

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Metoprolol succinateAlso: Toprol XLThe subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.	Drug	Initial treatment with metoprolol, Initial treatment with nebivolol
NebivololAlso: BystolicThe subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.	Drug	Initial treatment with metoprolol, Initial treatment with nebivolol
Forearm blood flowUsing high-resolution ultrasound, investigators will measure skeletal muscle blood flow in the forearm at rest, following handgrip exercise (described below), and following Angiotensin II infusion (described below).	Procedure or surgery	Initial treatment with metoprolol, Initial treatment with nebivolol
MicroneurographyAlso: Assessment of sympathetic nerve activity (SNA)Investigators will measure sympathetic nerve activity from the peroneal nerve by inserting a tiny needle directly into the nerve in the leg. Investigators will localize the nerve by electrical stimulation over the skin using a blunt probe. With this stimulation, subject will notice either involuntary twitching or a tingling sensation, which may be annoying but not painful. Investigators will then introduce a tiny, sterile wire needle (an electrode) through the skin at the same location. When the tip of the needle enters the nerve, subjects may again notice involuntary muscle twitches or tingling in the leg. Investigators will then turn the electrical stimulator off and make minor adjustments in the position of the needle until investigators begin to record the nerve signals. The recording needle will remain in position throughout the study.	Procedure or surgery	Initial treatment with metoprolol, Initial treatment with nebivolol
Rhythmic handgrip exerciseSubjects will perform a rhythmic handgrip exercise at 30% of maximal voluntary contraction for 3 minutes. Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure, and sympathetic nerve activity (SNA) at baseline and following this handgrip exercise.	Procedure or surgery	Initial treatment with metoprolol, Initial treatment with nebivolol
Lower body negative pressureAlso: LBNPLower body negative pressure increases sympathetic nerve activity. Therefore, investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure and sympathetic nerve activity at baseline and after rhythmic handgrip exercise plus lower body negative pressure (LBNP) for 2 minutes.	Procedure or surgery	Initial treatment with metoprolol, Initial treatment with nebivolol
Angiotensin IIAlso: IND #103,935Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure and sympathetic nerve activity at baseline and during intravenous infusion of Angiotensin II at the dose of 1, 2, and 3 ng/kg/min for 15 minutes at each dose.	Drug	Initial treatment with metoprolol, Initial treatment with nebivolol

Primary outcome

Forearm Blood Flow
Time frame: 12 weeks after each specified medication

2 secondary outcomes

Blood Pressure During Exercise
Time frame: 12 weeks
Blood Pressure During Angiotensin II Infusion
Time frame: 12 weeks after initiation of metoprolol

Results and safety

Results posted to the registry on 31 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metoprolol First Then Nebivolol	11	11
Nebivolol First, Then Metoprolol	10	10

Primary outcome: Forearm Blood Flow

Time frame: 12 weeks after each specified medication. Mean (Standard Deviation). Unit: ml/min

Measure	First Intervention Metoprolol: 12 Weeks n = 21	Second Intervention Nebivolol: 24 Weeks n = 21
Value	96 (1)	105 (13)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metoprolol 21 Subjects	0 of 21 (0%)	0 of 21 (0%)	Not reported
Nebivolol 21 Subjects	0 of 21 (0%)	0 of 21 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12588902Rosenmeier JB, Dinenno FA, Fritzlar SJ, Joyner MJ. alpha1- and alpha2-adrenergic vasoconstriction is blunted in contracting human muscle. J Physiol. 2003 Mar 15;547(Pt 3):971-6. doi: 10.1113/jphysiol.2002.037937. Epub 2003 Feb 14.
Background: PubMed 10759586Hansen J, Sander M, Thomas GD. Metabolic modulation of sympathetic vasoconstriction in exercising skeletal muscle. Acta Physiol Scand. 2000 Apr;168(4):489-503. doi: 10.1046/j.1365-201x.2000.00701.x.
Background: PubMed 9844020Thomas GD, Sander M, Lau KS, Huang PL, Stull JT, Victor RG. Impaired metabolic modulation of alpha-adrenergic vasoconstriction in dystrophin-deficient skeletal muscle. Proc Natl Acad Sci U S A. 1998 Dec 8;95(25):15090-5. doi: 10.1073/pnas.95.25.15090.
Background: PubMed 11325874Thomas GD, Zhang W, Victor RG. Impaired modulation of sympathetic vasoconstriction in contracting skeletal muscle of rats with chronic myocardial infarctions: role of oxidative stress. Circ Res. 2001 Apr 27;88(8):816-23. doi: 10.1161/hh0801.089341.
Background: PubMed 11927694Chavoshan B, Sander M, Sybert TE, Hansen J, Victor RG, Thomas GD. Nitric oxide-dependent modulation of sympathetic neural control of oxygenation in exercising human skeletal muscle. J Physiol. 2002 Apr 1;540(Pt 1):377-86. doi: 10.1113/jphysiol.2001.013153.
Background: PubMed 16940212Zhao W, Swanson SA, Ye J, Li X, Shelton JM, Zhang W, Thomas GD. Reactive oxygen species impair sympathetic vasoregulation in skeletal muscle in angiotensin II-dependent hypertension. Hypertension. 2006 Oct;48(4):637-43. doi: 10.1161/01.HYP.0000240347.51386.ea. Epub 2006 Aug 28.
Background: PubMed 14583335Murphey LJ, Morrow JD, Sawathiparnich P, Williams GH, Vaughan DE, Brown NJ. Acute angiotensin II increases plasma F2-isoprostanes in salt-replete human hypertensives. Free Radic Biol Med. 2003 Oct 1;35(7):711-8. doi: 10.1016/s0891-5849(03)00395-2.
Background: PubMed 10069678Dijkhorst-Oei LT, Stroes ES, Koomans HA, Rabelink TJ. Acute simultaneous stimulation of nitric oxide and oxygen radicals by angiotensin II in humans in vivo. J Cardiovasc Pharmacol. 1999 Mar;33(3):420-4. doi: 10.1097/00005344-199903000-00012.
Background: PubMed 12538430Vittorio TJ, Lang CC, Katz SD, Packer M, Mancini DM, Jorde UP. Vasopressor response to angiotensin II infusion in patients with chronic heart failure receiving beta-blockers. Circulation. 2003 Jan 21;107(2):290-3. doi: 10.1161/01.cir.0000045666.04794.14.
Background: PubMed 16940222Oelze M, Daiber A, Brandes RP, Hortmann M, Wenzel P, Hink U, Schulz E, Mollnau H, von Sandersleben A, Kleschyov AL, Mulsch A, Li H, Forstermann U, Munzel T. Nebivolol inhibits superoxide formation by NADPH oxidase and endothelial dysfunction in angiotensin II-treated rats. Hypertension. 2006 Oct;48(4):677-84. doi: 10.1161/01.HYP.0000239207.82326.29. Epub 2006 Aug 28.
Background: PubMed 15716701Fratta Pasini A, Garbin U, Nava MC, Stranieri C, Davoli A, Sawamura T, Lo Cascio V, Cominacini L. Nebivolol decreases oxidative stress in essential hypertensive patients and increases nitric oxide by reducing its oxidative inactivation. J Hypertens. 2005 Mar;23(3):589-96. doi: 10.1097/01.hjh.0000160216.86597.ff.
Background: PubMed 12748199Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wanpen Vongpatanasin, MD principal investigator

University of Texas Southwestern Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metoprolol succinate, Nebivolol and Forearm blood flow in people with Hypertension, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forearm Blood Flow (time frame: 12 weeks after each specified medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01502787, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.