NCT01504828

Brief Summary

Normal aging is characterized by altered cardiovascular function. Our preliminary data with MR imaging and spectroscopy in normal subjects without cardiovascular disease or hypertension show that age-related cardiac dysfunction is characterized initially by impaired relaxation of the heart (40 - 60 years), and then at \> 60 years altered contraction and impaired myocardial energetics. For the first time, the investigators will test whether the functional and energetic effects of normal aging can be reversed by acutely reducing stiffness of peripheral blood vessels using an ACE inhibitor. This will potentially have important insights into how normal aging affects the heart, and how potential treatments could be used to attenuate this process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

3.4 years

First QC Date

December 21, 2011

Last Update Submit

March 29, 2017

Conditions

Keywords

Energy MetabolismAgeingleft ventricleenergeticsfunction

Outcome Measures

Primary Outcomes (3)

  • Vascular Stiffness

    There are 3 principal measures of vascular stiffness, and these are central pulse pressure, central systolic pressure, and the augmentation index. These are correlated against the 3 principal measures of left ventricular function and energetics that are known to change with age: torsion to shortening ratio, early to late diastolic filling ratio, and the ratio of phosphocreatine to adenosine triphosphate (listed as separate Primary Outcome Measures).

    2 Hours - Acute study with no follow-up

  • Left Ventricular Energetics

    Left ventricular energetics is measured as the ratio of phosphocreatine to adenosine triphosphate

    2 hours - Acute Study, no follow-up

  • Left Ventricular Function

    Left ventricular function is measured with the 2 parameters that are known to change with age: ratio of early to late diastolic filling, and ratio of torsion to shortening ratio.

    2 hours - Acute Study, no follow-up

Secondary Outcomes (1)

  • Effects of ACE inhibitor on left ventricular energetics and function in those subjects aged 40 and over

    6 hours - Acute study, no follow-up

Study Arms (1)

Ramipril

EXPERIMENTAL

Those who are 40 years and older receive an ACE inhibitor to determine if this reduces age-related changes in left ventricular energetics and function

Drug: Ramipril

Interventions

Ramipril in one dose to reduce vascular stiffness to determine effects of this on left ventricular function and energetics

Ramipril

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects between the ages of 20 and 80 years

You may not qualify if:

  • Any cardiovascular condition including hypertension, or on any cardiovascular therapy.
  • Blood Pressure \> 150 mmHg systolic, and/or \> 90 mmHg diastolic
  • Claustrophobia
  • Implanted metal prosthesis
  • Chronic renal failure requiring dialysis
  • Diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus for Ageing and Vitality

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Related Publications (2)

  • Hollingsworth KG, Blamire AM, Keavney BD, Macgowan GA. Left ventricular torsion, energetics, and diastolic function in normal human aging. Am J Physiol Heart Circ Physiol. 2012 Feb 15;302(4):H885-92. doi: 10.1152/ajpheart.00985.2011. Epub 2011 Dec 16.

    PMID: 22180656BACKGROUND
  • Parikh JD, Hollingsworth KG, Kunadian V, Blamire A, MacGowan GA. Measurement of pulse wave velocity in normal ageing: comparison of Vicorder and magnetic resonance phase contrast imaging. BMC Cardiovasc Disord. 2016 Feb 19;16:50. doi: 10.1186/s12872-016-0224-4.

MeSH Terms

Interventions

Ramipril

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Guy A MacGowan, MD

    Freeman Hospital, Newcastle upon Tyne and Newcastle University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2011

First Posted

January 5, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations