Left Ventricular Function Systolic DysfunctionNCT01504828
Cardiac Energetics and Function in Normal Human Ageing
A study testing Ramipril in people with Left Ventricular Function Systolic Dysfunction and Left Ventricular Function Diastolic Dysfunction, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Ventricular Function Systolic Dysfunction, Left Ventricular Function Diastolic Dysfunction, Ageing
- What is being tested?
- Ramipril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Dec 2015
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects between the ages of 20 and 80 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Campus for Ageing and Vitality
Newcastle upon Tyne, NE4 6BE
About this study
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.
Read the detailed description
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 diastolic dysfunction (40 - 60 years), and then at > 60 years altered systolic strains and impaired myocardial energetics. The investigators propose to study the mechanism of these findings in subjects with normal aging without any cardiovascular disease, hypothesizing that increased vascular stiffening contributes to impaired energetics and left ventricular function. For the first time, the investigators will test whether the functional and energetic effects of normal aging can be reversed by acutely reducing afterload using an ACE inhibitor. This will be tested at 2 ages (40-60 and > 60 years), so that the intervention tests the hypothesis soon after the abnormalities develop (40-60 years - diastolic dysfunction; > 60 years energetics and altered strains). This will potentially have important insights into how normal aging affects the heart, and how potential treatments could be used to attenuate this process.
- Conditions
- Left Ventricular Function Systolic Dysfunction, Left Ventricular Function Diastolic Dysfunction, Ageing
- Being tested
- Ramipril
- Keywords
- Energy Metabolism, Ageing, left ventricle, energetics, function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
Ramipril in one dose to reduce vascular stiffness to determine effects of this on left ventricular function and energetics
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ramipril |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 Hours - Acute study with no follow-up
Left Ventricular Energetics
Left ventricular energetics is measured as the ratio of phosphocreatine to adenosine triphosphate
Measured: 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.
Measured: 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
A single dose of ACE inhibitor is given to reduce vascular stiffness, and we then measure the effects of this on the measures of left ventricular function and energetics which are the torsion to shortening ratio, diastolic early to late filling ratio, and the phosphocreatine to adenosine triphosphate ratio.
Measured: 6 hours - Acute study, no follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Function Systolic DysfunctionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy A MacGowan, MD, Principal investigator, Freeman Hospital, Newcastle upon Tyne and Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504828
- Sponsor's protocol ID
- BH111454
- Other IDs
- 95309
- Status last verified
- Mar 2017
- First submitted
- 21 Dec 2011
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22180656Parikh 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.
PubMed 26892669
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Energetics and Function in Normal Human Ageing
- ClinicalTrials.gov ID
- NCT01504828
- Acronym / sponsor ID
- BH111454
- Conditions
- Left Ventricular Function Systolic Dysfunction, Left Ventricular Function Diastolic Dysfunction, Ageing
- Keywords
- Energy Metabolism, Ageing, left ventricle, energetics, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 diastolic dysfunction (40 - 60 years), and then at > 60 years altered systolic strains and impaired myocardial energetics. The investigators propose to study the mechanism of these findings in subjects with normal aging without any cardiovascular disease, hypothesizing that increased vascular stiffening contributes to impaired energetics and left ventricular function. For the first time, the investigators will test whether the functional and energetic effects of normal aging can be reversed by acutely reducing afterload using an ACE inhibitor. This will be tested at 2 ages (40-60 and > 60 years), so that the intervention tests the hypothesis soon after the abnormalities develop (40-60 years - diastolic dysfunction; > 60 years energetics and altered strains). This will potentially have important insights into how normal aging affects the heart, and how potential treatments could be used to attenuate this process.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramipril | Experimental | Drug: RamiprilThose who are 40 years and older receive an ACE inhibitor to determine if this reduces age-related changes in left ventricular energetics and function |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female subjects between the ages of 20 and 80 years
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| RamiprilRamipril in one dose to reduce vascular stiffness to determine effects of this on left ventricular function and energetics | Drug | Ramipril |
Primary outcome
Vascular Stiffness
Time frame: 2 Hours - Acute study with no follow-up
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).
Left Ventricular Energetics
Time frame: 2 hours - Acute Study, no follow-up
Left ventricular energetics is measured as the ratio of phosphocreatine to adenosine triphosphate
Left Ventricular Function
Time frame: 2 hours - Acute Study, no follow-up
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.
1 secondary outcome
Effects of ACE inhibitor on left ventricular energetics and function in those subjects aged 40 and over
Time frame: 6 hours - Acute study, no follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Background: PubMed 22180656Hollingsworth 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.
- Derived from this study: PubMed 26892669Parikh 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.
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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.
Guy A MacGowan, MD principal investigator
Freeman Hospital, Newcastle upon Tyne and Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ramipril in people with Left Ventricular Function Systolic Dysfunction and Left Ventricular Function Diastolic Dysfunction, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 6 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 30 Mar 2017. 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 Kingdom. 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.
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?
Vascular Stiffness (time frame: 2 Hours - Acute study with no follow-up). The study lists 3 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 NCT01504828, which also lists 2 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 30 Mar 2017.