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Cardiovascular DiseasePhase 2NCT00277875

STRETCH Study: Effect of Distensibility on Endothelial-Dependent Vasoreactivity in Patients With ISH

A Phase 2 study testing ALT-711 (alagebrium chloride) in people with Cardiovascular Disease, run by Synvista Therapeutics, Inc 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
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Trial summary

Determine whether increasing arterial distensibility by decreasing advanced glycation end-product (AGE) cross-link components of vascular stiffness improves (a) endothelial-mediated vasoreactivity at rest, as assessed by flow-mediated vasodilation (FMD), and (b) endothelial-mediated vasoreactivity after exercise, as… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Cardiovascular Disease
What is being tested?
ALT-711 (alagebrium chloride)
How many people
25 participants
Where
1 siteUnited States
Study dates
Feb 2004to Jan 2006
Phase
Phase 2
Are there results?
None posted in the registry

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female 50 years of age or greater.
  • Diagnosed with systolic hypertension (systolic blood pressure >140 mm Hg and (less than or equal to) 200 mm Hg, and a diastolic blood pressure (less than or equal to) 95 mm Hg) and elevated pulse pressure (systolic blood pressure [SBP] minus diastolic blood pressure [DBP] greater than 60 mm Hg).
  • Normal left ventricular function (ejection fraction >55%) at baseline (Visit 3).
  • Able to perform bicycle exercise.
  • Able to read, understand and sign the informed consent after the nature of the study has been explained.
  • If sexually active, the patient agrees to use reliable contraception while participating in this study. If a woman, is surgically sterilized or post-menopausal, or has a negative serum pregnancy test.

Who cannot join

  • Aortic stenosis, prior known coronary artery disease (including myocardial infarction), cerebrovascular accident, or peripheral vascular disease.
  • Uncontrolled hypertension (SBP > 200/ DBP > 95 mm Hg).
  • Atrial fibrillation, diabetes mellitus treated with insulin, or chronic lung disease.
  • Any additional condition(s) which, in the opinion of the investigator, would prohibit the patient from completing the study, or not be in the best interest of the patient.
  • Treatment with nitrates, or a change in antihypertensive medications within the last 1 month.
  • Treatment with any investigational drug within 1 month prior to study drug administration.
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  • Previous exposure to alagebrium.
  • AST (SGOT) or ALT (SGPT) > 2x normal limit.
  • Serum creatinine > 2.0 ng/mL.
  • Cigar/cigarette smoking.
  • Necessity to use smokeless tobacco or nicotine-containing products, or to consume caffeine, alcohol, or antioxidants starting at midnight prior to study clinic visits. NOTE: Water is allowed ad libitim.
  • Positive drug screen.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: The Effect of Vascular Distensibility on Endothelial-Dependent Vasoreactivity in Patients With Systolic Hypertension Before and After Receiving Oral Alagebrium for 8 Weeks.

Determine whether increasing arterial distensibility by decreasing advanced glycation end-product (AGE) cross-link components of vascular stiffness improves (a) endothelial-mediated vasoreactivity at rest, as assessed by flow-mediated vasodilation (FMD), and (b) endothelial-mediated vasoreactivity after exercise, as assessed by pulse perfusion-mediated vasodilation (PPMV).

Read the detailed description
  • Explore several independent variables as potential independent predictors of vascular stiffness and endothelial function. These parameters include patient age, body mass index, gender, renal disease, history of cardiovascular disease, serum cholesterol, and antihypertensive medication use.
  • Provide insight into nitric oxide-dependent endothelial function in the setting of increased arterial stiffness by determination of substances in the nitric oxide signaling pathway (specifically, levels of serum cGMP; serum nitrate and nitrite; and serum asymmetric dimethylarginine [ADMA], an endogenous inhibitor of nitric oxide synthase).
  • Provide insight into changes in AGE levels and collagen metabolism in response to alagebrium therapy [specifically, AGEs: pentosidine, carboxymethyllysine, carboxyethyllysine, furosine; Collagen markers: procollagen I carboxyterminal propeptide (PICP), procollagen type I N terminal propeptide (PINP), cross-linked carboxyterminal telopeptide of Type I collagen (ICTP), n-terminal propeptide of type III procollagen (PIIINP)].
  • Provide insight into changes in markers of inflammation in response to alagebrium therapy [specifically, free and total serum matrix metalloproteinase-1(MMP-1), free tissue inhibitor of metalloproteinase 1 (TIMP1), intercellular adhesion molecule-1 (ICAM), P-selectin, von Willebrand factor (vWf), interleukin-6 (IL-6), and high-sensitivity C reactive protein (hs CRP)].
Being tested
ALT-711 (alagebrium chloride)
Keywords
Cardiovascular, Flow-Mediated Vasodilation (FMD), Pulse Perfusion-Mediated Vasodilation (PPMV), Endothelial Function, Heart Failure, Local Distensibility, Arterial Stiffening, Augmentation Index (AI), Aging, Isolated Systolic Hypertension, Advanced Glycation Endproducts, Vascular Stiffness
Medical subject headings
Cardiovascular Diseases, Heart Failure, Isolated Systolic Hypertension

What participants receive

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

  • ALT-711 (alagebrium chloride)Drug

What is being measured

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

  1. Endothelial function

  2. Local distensibility

  3. Arterial stiffening

  4. Augmentation index (AI)

  5. Markers of endothelial function, vascular inflammation and collagen synthesis.

Timeline

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

  1. First posted18 Jan 2006 (estimated)
  2. Study startFeb 2004
  3. Primary completionDec 2004
  4. Study completionJan 2006

Resources

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 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Enrolment
25 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00277875
Sponsor's protocol ID
ALT-711-0217
Status last verified
Jan 2006
First submitted
13 Jan 2006
Last updated
27 Aug 2009
Results posted
No
Data monitoring committee
No

Publications

  • Kass DA, Shapiro EP, Kawaguchi M, Capriotti AR, Scuteri A, deGroof RC, Lakatta EG. Improved arterial compliance by a novel advanced glycation end-product crosslink breaker. Circulation. 2001 Sep 25;104(13):1464-70. doi: 10.1161/hc3801.097806.

    PubMed 11571237

  • Liu ZR, Ting CT, Zhu SX, Yin FC. Aortic compliance in human hypertension. Hypertension. 1989 Aug;14(2):129-36. doi: 10.1161/01.hyp.14.2.129.

    PubMed 2759675

  • Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.

    PubMed 11788217

  • Deng YB, Wang XF, Le GR, Zhang QP, Li CL, Zhang YG. Evaluation of endothelial function in hypertensive elderly patients by high-resolution ultrasonography. Clin Cardiol. 1999 Nov;22(11):705-10. doi: 10.1002/clc.4960221105.

    PubMed 10554684

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALT-711 (alagebrium chloride) in people with Cardiovascular Disease, run by Synvista Therapeutics, Inc 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 6 inclusion and 12 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 27 Aug 2009. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Endothelial function. The study lists 5 primary outcomes in all. 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 NCT00277875, which also lists 4 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 27 Aug 2009.

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