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

NCT00874432 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: H-2008-0221A534280SMPH/MEDICINE/NEPHROLOGY
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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 stage 3 CKD in a randomized, controlled study.

Conditions

Cardiovascular Disease; Chronic Kidney Disease

Keywords

cardiovascular disease; angiotensin converting enzyme inhibitors; chronic kidney disease; cardiovascular disease in elderly patients with CKD

Outcome Measures

Primary Outcomes (1)

• Aortic Pulse Wave Velocity (PWV)

  PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.

  up to 12 months

Secondary Outcomes (2)

• Mean Vascular Stiffness As Measured by PWV

  baseline and 12 months

• Change in Blood Pressure From Baseline to 12 Months

  up to 12 months

Study Arms (4)

Chronic Kidney Disease-ACE-I

ACTIVE COMPARATOR

ace inhibitor

Drug: lisinopril

Chronic Kidney Disease

PLACEBO COMPARATOR

Drug: angiotensin converting enzyme inhibitor

Age matched control-ACE-I

ACTIVE COMPARATOR

ace-inhibitor

Drug: lisinopril

Age matched control

PLACEBO COMPARATOR

Placebo

Drug: angiotensin converting enzyme inhibitor

Interventions

angiotensin converting enzyme inhibitor DRUG

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

Also known as: ACE-inhibitor

Age matched control; Chronic Kidney Disease

lisinopril DRUG

1 x 40 mg per day

Also known as: ace inhibitor

Age matched control-ACE-I; Chronic Kidney Disease-ACE-I

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison Hospitals and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (35)

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  BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Renal Insufficiency, Chronic

Interventions

Angiotensin-Converting Enzyme Inhibitors; Lisinopril

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Arjang Djamali
• Organization: University of Wisconsin - Madison

axd@medicine.wisc.edu

(608) 262-9306

Study Officials

• Arjang Djamali, MD

  University of Wisconsin-Madison School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

• Laura Maursetter, DO

  University of Wisconsin, Madison

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2011
• Last Updated: October 27, 2020
• Results First Posted: September 23, 2020

Record last verified: 2020-10

Locations

US (1)