Cardiovascular DiseasePhase 2NCT00874432

Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease

A Phase 2 study testing angiotensin converting enzyme inhibitor and lisinopril in people with Cardiovascular Disease and Chronic Kidney Disease, run by University of Wisconsin, Madison 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 goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining their impact on aortic stiffness in people with… Read more about this study

Who is it for?: Ages 60 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Disease, Chronic Kidney Disease
What is being tested?: angiotensin converting enzyme inhibitor and lisinopril
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Dec 2011
Phase: Phase 2
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 60 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age > 60 years
BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure < 130/80 - IF bp remains > 130/80 we will administer other bp meds per JNC VII guidelines)
CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group

Who cannot join

Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New York Heart Association (NYHA) class III or greater).
Serum potassium > 5.2 meq/L
Known allergy or hypersensitivity to ACE inhibitor or ARB
Female of childbearing age not practicing contraception
Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week washout period)
History of ACE-I induced angioedema

Show all 9Show fewer

History of angioedema, hereditary or idiopathic
Persons lacking consent capacity
500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin-Madison Hospitals and Clinics
Madison, Wisconsin, 53792

Other trials in United States

About this study

Read the detailed description

This study will be the first to examine whether aortic stiffness is increased in elderly patients with CKD compared to their age-matched healthy controls and further examine whether ACE-I may delay the progression of aortic stiffness in elderly CKD patients. If ACE-I therapy appears beneficial in preventing or delaying arterial stiffening in elderly patients with CKD, this work has important implications for improving the overall health of this population.

Conditions: Cardiovascular Disease, Chronic Kidney Disease
Being tested: angiotensin converting enzyme inhibitor, lisinopril
Keywords: cardiovascular disease, angiotensin converting enzyme inhibitors, chronic kidney disease, cardiovascular disease in elderly patients with CKD
Medical subject headings: Cardiovascular Diseases, Renal Insufficiency, Chronic

What participants receive

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

angiotensin converting enzyme inhibitorDrug
Also called ACE-inhibitor
Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
lisinoprilDrug
Also called ace inhibitor
1 x 40 mg per day

Study groups in NCT00874432
Study group	Role	What they receive
Chronic Kidney Disease-ACE-I	Active comparator	ace inhibitor Receives: Drug: lisinopril
Chronic Kidney Disease	Placebo comparator	Not described Receives: Drug: angiotensin converting enzyme inhibitor
Age matched control-ACE-I	Active comparator	ace-inhibitor Receives: Drug: lisinopril
Age matched control	Placebo comparator	Placebo Receives: Drug: angiotensin converting enzyme inhibitor

What is being measured

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

Aortic Pulse Wave Velocity (PWV)
PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.
Measured: up to 12 months

Secondary outcomes (2)

Mean Vascular Stiffness As Measured by PWV
Comparison between Participants with Stage 3 Chronic Kidney Disease (CKD) and age matched Controls without CKD. The numbers reported are the mean of all the participants in the group at two points in time - the baseline and at 12 months for CFPWV, CBPWV, and CRPWV.
Carotid-Femoral Pulse Wave Velocity (CFPWV) Carotid-Brachial Pulse Wave Velocity (CBPWV) Carotid-Radial Pulse Wave Velocity (CRPWV)
Measured: baseline and 12 months
Change in Blood Pressure From Baseline to 12 Months
Change in Blood Pressure will be used to measure the effect of ACE-inhibitors on the clinical markers of Cardiovascular Disease in participants with stage 3 CKD.
Measured: up to 12 months

Timeline

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

Jan 2009Dec 2011

First posted2 Apr 2009 (estimated)
Study startJan 2009
Primary completionDec 2009
Study completionDec 2011

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 (35)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00874432
Sponsor's protocol ID: H-2008-0221
Other IDs: A534280, SMPH/MEDICINE/NEPHROLOGY
Status last verified: Oct 2020
First submitted: 1 Apr 2009
Last updated: 27 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Ryan TP, Sloand JA, Winters PC, Corsetti JP, Fisher SG. Chronic kidney disease prevalence and rate of diagnosis. Am J Med. 2007 Nov;120(11):981-6. doi: 10.1016/j.amjmed.2007.05.012.
PubMed 17976426
Foley RN, Parfrey PS. Cardiovascular disease and mortality in ESRD. J Nephrol. 1998 Sep-Oct;11(5):239-45.
PubMed 9831236
Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension. 2001 Oct;38(4):938-42. doi: 10.1161/hy1001.096358.
PubMed 11641313
Covic A, Haydar AA, Bhamra-Ariza P, Gusbeth-Tatomir P, Goldsmith DJ. Aortic pulse wave velocity and arterial wave reflections predict the extent and severity of coronary artery disease in chronic kidney disease patients. J Nephrol. 2005 Jul-Aug;18(4):388-96.
PubMed 16245242
London GM, Marchais SJ, Guerin AP. Arterial stiffness and function in end-stage renal disease. Adv Chronic Kidney Dis. 2004 Apr;11(2):202-9. doi: 10.1053/j.arrt.2004.02.008.
PubMed 15216492
Wang MC, Tsai WC, Chen JY, Huang JJ. Stepwise increase in arterial stiffness corresponding with the stages of chronic kidney disease. Am J Kidney Dis. 2005 Mar;45(3):494-501. doi: 10.1053/j.ajkd.2004.11.011.
PubMed 15754271
Kundhal K, Lok CE. Clinical epidemiology of cardiovascular disease in chronic kidney disease. Nephron Clin Pract. 2005;101(2):c47-52. doi: 10.1159/000086221. Epub 2005 Jun 7.
PubMed 15942250
Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70. doi: 10.1161/CIRCULATIONAHA.105.579342.
PubMed 16461839
London GM, Guerin AP, Marchais SJ, Pannier B, Safar ME, Day M, Metivier F. Cardiac and arterial interactions in end-stage renal disease. Kidney Int. 1996 Aug;50(2):600-8. doi: 10.1038/ki.1996.355.
PubMed 8840292
Shinohara K, Shoji T, Tsujimoto Y, Kimoto E, Tahara H, Koyama H, Emoto M, Ishimura E, Miki T, Tabata T, Nishizawa Y. Arterial stiffness in predialysis patients with uremia. Kidney Int. 2004 Mar;65(3):936-43. doi: 10.1111/j.1523-1755.2004.00468.x.
PubMed 14871413
Safar ME, London GM, Plante GE. Arterial stiffness and kidney function. Hypertension. 2004 Feb;43(2):163-8. doi: 10.1161/01.HYP.0000114571.75762.b0. Epub 2004 Jan 19.
PubMed 14732732
Dao HH, Essalihi R, Bouvet C, Moreau P. Evolution and modulation of age-related medial elastocalcinosis: impact on large artery stiffness and isolated systolic hypertension. Cardiovasc Res. 2005 May 1;66(2):307-17. doi: 10.1016/j.cardiores.2005.01.012.
PubMed 15820199
Ferrari AU, Radaelli A, Centola M. Invited review: aging and the cardiovascular system. J Appl Physiol (1985). 2003 Dec;95(6):2591-7. doi: 10.1152/japplphysiol.00601.2003.
PubMed 14600164
Mitchell GF, Parise H, Benjamin EJ, Larson MG, Keyes MJ, Vita JA, Vasan RS, Levy D. Changes in arterial stiffness and wave reflection with advancing age in healthy men and women: the Framingham Heart Study. Hypertension. 2004 Jun;43(6):1239-45. doi: 10.1161/01.HYP.0000128420.01881.aa. Epub 2004 May 3.
PubMed 15123572
Sawabe M, Takahashi R, Matsushita S, Ozawa T, Arai T, Hamamatsu A, Nakahara K, Chida K, Yamanouchi H, Murayama S, Tanaka N. Aortic pulse wave velocity and the degree of atherosclerosis in the elderly: a pathological study based on 304 autopsy cases. Atherosclerosis. 2005 Apr;179(2):345-51. doi: 10.1016/j.atherosclerosis.2004.09.023. Epub 2004 Dec 13.
PubMed 15777552

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 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT00874432
Acronym / sponsor ID: H-2008-0221
Conditions: Cardiovascular Disease, Chronic Kidney Disease
Keywords: cardiovascular disease, angiotensin converting enzyme inhibitors, chronic kidney disease, cardiovascular disease in elderly patients with CKD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: Jan 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2011 (actual)
First posted: 2 Apr 2009 (estimated)
Results: Posted 23 Sep 2020

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Chronic Kidney Disease-ACE-I	Active comparator	Drug: lisinoprilace inhibitor
Chronic Kidney Disease	Placebo comparator	Drug: angiotensin converting enzyme inhibitor
Age matched control-ACE-I	Active comparator	Drug: lisinoprilace-inhibitor
Age matched control	Placebo comparator	Drug: angiotensin converting enzyme inhibitorPlacebo

Who may qualify

Ages: 60 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age > 60 years
BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure < 130/80 - IF bp remains > 130/80 we will administer other bp meds per JNC VII guidelines)
CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group

Key exclusion criteria (9 listed)

Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New York Heart Association (NYHA) class III or greater).
Serum potassium > 5.2 meq/L
Known allergy or hypersensitivity to ACE inhibitor or ARB
Female of childbearing age not practicing contraception
Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week washout period)

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
angiotensin converting enzyme inhibitorAlso: ACE-inhibitorActive comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day	Drug	Age matched control, Chronic Kidney Disease
lisinoprilAlso: ace inhibitor1 x 40 mg per day	Drug	Age matched control-ACE-I, Chronic Kidney Disease-ACE-I

Primary outcome

Aortic Pulse Wave Velocity (PWV)
Time frame: up to 12 months
PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.

2 secondary outcomes

Mean Vascular Stiffness As Measured by PWV
Time frame: baseline and 12 months
Change in Blood Pressure From Baseline to 12 Months
Time frame: up to 12 months

Results and safety

Results posted to the registry on 23 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chronic Kidney Disease-ACE-I	8	5
Chronic Kidney Disease	4	2
Age Matched Control-ACE-I	17	9
Age Matched Control	14	11

Primary outcome: Aortic Pulse Wave Velocity (PWV)

Time frame: up to 12 months. Mean (Standard Deviation). Unit: m/s

Measure	Chronic Kidney Disease n = 11	Age Matched Control n = 22
Carotid-Femoral Pulse Wave Velocity	9.90 (1.12)	9.96 (2.52)
Carotid-Brachial Pulse Wave Velocity	7.62 (1.76)	8.57 (1.46)
Carotid-Radial Pulse Wave Velocity	9.03 (2.12)	8.38 (1.76)

Chronic Kidney Disease vs Age Matched Control: p = 0.685, t-test, 2 sided
Chronic Kidney Disease vs Age Matched Control: p = 0.739, t-test, 2 sided
Chronic Kidney Disease vs Age Matched Control: p = 0.471, t-test, 2 sided

Population analysed: Comparison of the baseline pulse wave velocity measures between the two groups (CKD vs no CKD) prior to intervention with ACE inhibitor. Data analyzed is from 32 participants due to drop out either from study self withdrawal (3) or ineligibility (1 = BP too low to start medication) and 7 without adequate testing data available for analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Kidney Disease-ACE-I	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Chronic Kidney Disease	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Age Matched Control-ACE-I	0 of 17 (0%)	3 of 17 (17.6%)	0 of 17
Age Matched Control	0 of 14 (0%)	1 of 14 (7.1%)	0 of 14

Limitations and caveats (from the sponsor): There is limited data for this study, the PI is now in private practice and some raw data no longer exists to answer this outcome. We have done our due diligence to populate this record with data that remains.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17976426Ryan TP, Sloand JA, Winters PC, Corsetti JP, Fisher SG. Chronic kidney disease prevalence and rate of diagnosis. Am J Med. 2007 Nov;120(11):981-6. doi: 10.1016/j.amjmed.2007.05.012.
Background: PubMed 9831236Foley RN, Parfrey PS. Cardiovascular disease and mortality in ESRD. J Nephrol. 1998 Sep-Oct;11(5):239-45.
Background: PubMed 11641313Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension. 2001 Oct;38(4):938-42. doi: 10.1161/hy1001.096358.
Background: PubMed 16245242Covic A, Haydar AA, Bhamra-Ariza P, Gusbeth-Tatomir P, Goldsmith DJ. Aortic pulse wave velocity and arterial wave reflections predict the extent and severity of coronary artery disease in chronic kidney disease patients. J Nephrol. 2005 Jul-Aug;18(4):388-96.
Background: PubMed 15216492London GM, Marchais SJ, Guerin AP. Arterial stiffness and function in end-stage renal disease. Adv Chronic Kidney Dis. 2004 Apr;11(2):202-9. doi: 10.1053/j.arrt.2004.02.008.
Background: PubMed 15754271Wang MC, Tsai WC, Chen JY, Huang JJ. Stepwise increase in arterial stiffness corresponding with the stages of chronic kidney disease. Am J Kidney Dis. 2005 Mar;45(3):494-501. doi: 10.1053/j.ajkd.2004.11.011.
Background: PubMed 15942250Kundhal K, Lok CE. Clinical epidemiology of cardiovascular disease in chronic kidney disease. Nephron Clin Pract. 2005;101(2):c47-52. doi: 10.1159/000086221. Epub 2005 Jun 7.
Background: PubMed 16461839Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70. doi: 10.1161/CIRCULATIONAHA.105.579342.
Background: PubMed 8840292London GM, Guerin AP, Marchais SJ, Pannier B, Safar ME, Day M, Metivier F. Cardiac and arterial interactions in end-stage renal disease. Kidney Int. 1996 Aug;50(2):600-8. doi: 10.1038/ki.1996.355.
Background: PubMed 14871413Shinohara K, Shoji T, Tsujimoto Y, Kimoto E, Tahara H, Koyama H, Emoto M, Ishimura E, Miki T, Tabata T, Nishizawa Y. Arterial stiffness in predialysis patients with uremia. Kidney Int. 2004 Mar;65(3):936-43. doi: 10.1111/j.1523-1755.2004.00468.x.
Background: PubMed 14732732Safar ME, London GM, Plante GE. Arterial stiffness and kidney function. Hypertension. 2004 Feb;43(2):163-8. doi: 10.1161/01.HYP.0000114571.75762.b0. Epub 2004 Jan 19.
Background: PubMed 15820199Dao HH, Essalihi R, Bouvet C, Moreau P. Evolution and modulation of age-related medial elastocalcinosis: impact on large artery stiffness and isolated systolic hypertension. Cardiovasc Res. 2005 May 1;66(2):307-17. doi: 10.1016/j.cardiores.2005.01.012.

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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.

Arjang Djamali, MD principal investigator

University of Wisconsin-Madison School of Medicine and Public Health

Laura Maursetter, DO study director

University of Wisconsin, Madison

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

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 9 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 Oct 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 23 Sep 2020). 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?

Aortic Pulse Wave Velocity (PWV) (time frame: up to 12 months). 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 NCT00874432, which also lists 35 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 Oct 2020.