Heart FailureSACARNCT00588692
Strategies for Aggressive Central Afterload Reduction in Patients With Heart Failure
A study testing SphygmoCor in people with Heart Failure, run by Mayo Clinic at 2 sites in United States.
Trial summary
Heart failure (HF) is the leading cause of hospitalization among Americans over the age of 65 years, affecting greater than 5 million in the U.S. alone. Significant improvements in morbidity and mortality have been achieved through the use of medications that antagonize adverse neurohormonal signaling pathways… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- SphygmoCor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Dec 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or greater
- Cardiac Ejection Fraction (EF) greater than or equal to 25% by echocardiography within 12 months
- Stable New York Heart Association (NYHA) class II or greater
- Heart Failure consultation within the last 18 months
- Ability to exercise on a cycle ergometer
- Stable angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) dosage for greater than 3 months
Who cannot join
- Enrollment in a concurrent study that may confound the results of this study
- Subjects with medical conditions that would limit study participation
- Pregnancy
- Brachial Systolic Blood Pressure less than 110 mmHg
- Baseline AIx less than 15%
- Cardiac Surgery with 60 days of potential study enrollment
Show all 16Show fewer
- Myocardial infarction within 30 days of potential study enrollment
- Hemodynamically significant valvular stenosis (greater than mild)
- Heart failure due to thyroid disease
- Active myocarditis or anemia defined as hemoglobin less than 9 mg/dl
- Presence of severe renal insufficiency with serum creatinine greater than 2.5 mg/dl
- Significant pulmonary hypertension or Cor pumonale
- Irregular heart rhythms
- Dyspnea due to pulmonary disease
- Uninterpretable echocardiographic images or radial tonometry data
- Significant competing cause for exercise intolerance (e.g., severe stable angina)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Arizona
Phoenix, Arizona, 85004
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Heart failure (HF) is the leading cause of hospitalization among Americans over the age of 65 years, affecting greater than 5 million in the U.S. alone. Significant improvements in morbidity and mortality have been achieved through the use of medications that antagonize adverse neurohormonal signaling pathways, particularly therapies that reduce left ventricular (LV) afterload.
Vascular stiffness increases with aging, contributing to the increase in cardiac load. One important repercussion of such stiffening is an increase in pulse wave velocity. As the incident pressure wave generated by cardiac ejection encounters zones of impedance mismatch (such as arterial bifurcations), part of the wave is reflected backward, summing with the incident wave, increasing central blood pressure (CBP). With normal aging, hypertension, and heart failure, increased wave velocity causes the reflected wave to reach the heart earlier, in mid to late systole, considerably increasing late-systolic load, impairing cardiac ejection, and diastolic relaxation in the ensuing cardiac cycle.
Read more
The magnitude of this reflected pressure wave can be quantified by the augmentation index (AIx). The use of vasoactive agents which antagonize this increase in late systolic load (and AIx) may prove useful in the treatment of heart failure, by facilitating cardiac ejection during late systole when reflected pressure waves predominate. However, it has never been conclusively shown in humans that CBP-targeted therapy is useful in the management of HF.
LV afterload, measured centrally in the ascending aorta, may differ considerably from brachial cuff-measured pressure, and has traditionally required invasive hemodynamic assessment to determine, limiting the applicability of techniques targeting CBP and late-systolic load. Recently, a novel, hand-held tonometer (SphygmoCor, Atcor Medical) has been developed for the noninvasive assessment of CBP. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure. This device has received FDA approval for clinical use in the assessment of central pressures. However, it remains unknown whether knowledge of CBP and late-systolic load (AIx) confers any clinically-significant incremental benefit in the management of patients with heart failure. The primary objective of the proposed investigation will be to determine if this assessment might have such a role.
Read the detailed description
Research Design and Methods
Hypotheses Knowledge of central aortic pressure waveforms (central pressure therapy, CPT) will affect the intensity of antihypertensive medication prescription, and treatment decisions based upon this knowledge in turn will lead to an enhanced reduction in CBP and AIx. Finally, it is hypothesized that this reduction in AIx/CBP will lead to improved exercise performance and LV systolic and diastolic reserve function.
Basic Study Plan This is a single-blind, randomized, controlled, parallel group intervention study examining the effects of a novel, noninvasive diagnostic test for determining AIx and CBP (SphygmoCor, Atcor Medical) on medical care, blood pressure control, exercise performance, and LV functional reserve in patients with chronic heart failure (HF) and systolic dysfunction (25%<EF<50%) and with preserved systolic function (EF>50%). Eligible subjects will undergo resting echocardiogram, noninvasive CBP assessment, and metabolic exercise stress testing on a recumbent cycle ergometer to quantify exercise performance. Echocardiography and CBP assessment will be performed at rest, during graded exercise, and immediately after peak exercise to determine indexes of LV systolic and diastolic performance and changes in CBP. Subjects will then be randomized (1:1) to subsequent determination of CBP at 1 month heart failure clinic visits versus sham (tonometry information acquired, but not shared with investigator). Investigators will then make adjustments to subject's medical therapy and antihypertensive regimen based upon the additional data procured via the Sphygmocor device. Subjects randomized to sham will have adjustments made as per standard clinical judgment based upon brachial blood pressure assessment and other clinical variables. In addition to standard clinical assessment, each subject will undergo 6 minute walk test at each visit, administered by the study coordinator.
At the 6 month follow up visit, subjects will undergo resting and exercise echo/CBP/metabolic stress testing exactly as performed at visit 1. The co-primary endpoints will be the change in central augmentation index (defined below) and change in peak oxygen uptake (VO2) from baseline. Secondary endpoints will include the changes in resting and exercise-induced CBP and brachial blood pressures, number of antihypertensive medications prescribed, resting and exercise change in LV systolic and diastolic function (see below), changes in: cardiac output, exercise time, anaerobic threshold, minute ventilation (VE) over carbon dioxide produced (VCO2) slope (ventilatory efficiency). There will be a total of 7 visits, the first and last for exercise testing; the intervening 5 visits will be routine heart failure clinic follow up appointments.
- Conditions
- Heart Failure
- Being tested
- SphygmoCor
- Keywords
- Heart Failure, Afterload Reduction, Sphygmocor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SphygmoCorDevice
The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure.
| Study group | Role | What they receive |
|---|---|---|
| SphygmoCor Unblinded | Active comparator | The use of the sphygmocor values will determine medication adjustments to optimize HF treatment. Receives: Device: SphygmoCor |
| SphygmoCor Blinded | Placebo comparator | Sphygmocor values will be blinded to the investigator. Receives: Device: SphygmoCor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Oxygen Uptake (VO2) During Maximal Effort Exercise Stress Test According to Ejection Fraction Subgroups
Peak oxygen uptake (VO2) is the maximum rate of oxygen consumption as measured during incremental exercise, most typically on a motorized treadmill. Maximal oxygen consumption reflects the aerobic physical fitness of the individual. VO2 data was obtained via standard breath-by-breath expired gas analysis. Ejection Fraction Subgroups are based on participants reported at baseline.
Measured: baseline, 6 months
Change in Aortic Augmentation Index (AIx) According to Ejection Fraction Subgroups
Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx.
Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx).
Measured: baseline, 6 months
Secondary outcomes (14)
Change in Heart Rate
Measured: baseline, six months
Change in Left Ventricle (LV) End Diastolic Volume
End-diastolic volume (EDV) is the volume of blood in the right and/or left ventricle at end load or filling in (diastole). An increase in EDV increases the preload on the heart and, through the Frank-Starling mechanism of the heart, increases the amount of blood ejected from the ventricle during systole (stroke volume).
Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7). LV EDV was determined from the apical 4 and 2 chamber views using Simpson's method of discs, along with ejection fraction (EF).
Measured: baseline, 6 months
Change in LV End Systolic Volume
End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle. End systolic volume can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.
Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7). LV end systolic volumes was determined from the apical 4 and 2 chamber views using Simpson's method of discs, along with EF.
Measured: baseline, 6 months
Change in LV Ejection Fraction
The ejection fraction is the percentage of the volume in the left ventricle ejected during a cardiac cycle. The normal ejection fraction is 55 to 75 percent. EF = (EDV - ESV) / EDV where EF = ejection fraction, EDV = volume of blood in the left ventricle at end-diastole, ESV = volume of blood in the left ventricle at end-systole.
Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7).
Measured: baseline, 6 months
Change in Stroke Volume
Stroke volume (SV) is the volume of blood pumped from one ventricle of the heart with each beat. SV was determined from pulse wave (PW) and continuous wave (CW) Doppler in the LV outflow tract.
Measured: baseline, 6 months
Change in Mitral E Velocity
The Mitral E velocity is the speed at which blood fills the ventricle. It is determined by echocardiography, an ultrasound-based cardiac imaging modality.
Measured: baseline, 6 months
Change in Mitral E/A Ratio
The E/A ratio is a marker of the function of the left ventricle of the heart; it is determined by echocardiography, an ultrasound-based cardiac imaging modality. Abnormalities in the E/A ratio on Doppler echocardiography suggest that the left ventricle, which pumps blood into the circulation, cannot fill with blood properly in the period between contractions. The E/A ratio is the ratio of peak early transmitral inflow velocity and peak late mitral inflow velocity.
Measured: baseline, 6 months
Change in Mitral E Wave Deceleration Time
The deceleration time (DT) is the time taken from the maximum E point to baseline. Normally in adults it is less than 220 milliseconds. The DT was measured by pulse wave doppler.
Measured: baseline, 6 months
Change in Brachial Systolic Blood Pressure (BP)
Blood pressure is a measure of the force of the blood flowing against the walls of your arteries as it moves through your body.
There are two numbers in a blood pressure reading. This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood. The second or lower number is the diastolic pressure and is the measure taken when your heart is at rest (80 in the example)
Brachial systolic BP was determined by a standard oscillometric device (Dinemap, Critikon).
Measured: baseline, 6 months
Change in Brachial Diastolic BP
Blood pressure is a measure of the force of the blood flowing against the walls of your arteries as it moves through your body.
There are two numbers in a blood pressure reading. This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood. The second or lower number is the diastolic pressure and is the measure taken when your heart is at rest (80 in the example)
Brachial diastolic BP was determined by a standard oscillometric device (Dinemap, Critikon).
Measured: baseline, 6 months
Change in Central Systolic BP
Central blood pressure (CBP) is the pressure in the aorta, which is the large artery into which the heart pumps. This was determined by noninvasive radial tonometry, which undergoes transfer function using customized software to derive CBP tracings.
Measured: baseline, 6 months
Change in Central Diastolic BP
Central blood pressure (CBP) is the pressure in the aorta, which is the large artery into which the heart pumps. This was determined by noninvasive radial tonometry, which undergoes transfer function using customized software to derive CBP tracings.
Measured: baseline, 6 months
Change in Augmentation Index
Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx.
Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx).
Measured: baseline, 6 months
Change in Arterial Elastance
Elastance is a measure of the tendency of a hollow organ to recoil toward its original dimensions upon removal of a distending or compressing force. Effective arterial elastance was determined by the ratio of end systolic BP/stroke volume (SV).
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionNov 2012
- Study completionDec 2012
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 (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- AtCor Medical, Inc.
- Responsible party
- Principal investigator, Barry Borlaug, Mayo Clinic
- Investigators
- Barry A. Borlaug, MD, Principal investigator, Staff Physician, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588692
- Sponsor's protocol ID
- 07-002008
- Acronym
- SACAR
- Status last verified
- Apr 2014
- First submitted
- 21 Dec 2007
- Last updated
- 6 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wohlfahrt P, Melenovsky V, Redfield MM, Olson TP, Lin G, Abdelmoneim SS, Hametner B, Wassertheurer S, Borlaug BA. Aortic Waveform Analysis to Individualize Treatment in Heart Failure. Circ Heart Fail. 2017 Feb;10(2):e003516. doi: 10.1161/CIRCHEARTFAILURE.116.003516.
PubMed 28159826Borlaug BA, Olson TP, Abdelmoneim SS, Melenovsky V, Sorrell VL, Noonan K, Lin G, Redfield MM. A randomized pilot study of aortic waveform guided therapy in chronic heart failure. J Am Heart Assoc. 2014 Mar 20;3(2):e000745. doi: 10.1161/JAHA.113.000745.
PubMed 24650926
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Aggressive Central Afterload Reduction in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT00588692
- Acronym / sponsor ID
- SACAR / 07-002008
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Afterload Reduction, Sphygmocor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- AtCor Medical, Inc.
- Study start
- Jul 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Posted 6 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure (HF) is the leading cause of hospitalization among Americans over the age of 65 years, affecting greater than 5 million in the U.S. alone. Significant improvements in morbidity and mortality have been achieved through the use of medications that antagonize adverse neurohormonal signaling pathways, particularly therapies that reduce left ventricular (LV) afterload.
Vascular stiffness increases with aging, contributing to the increase in cardiac load. One important repercussion of such stiffening is an increase in pulse wave velocity. As the incident pressure wave generated by cardiac ejection encounters zones of impedance mismatch (such as arterial bifurcations), part of the wave is reflected backward, summing with the incident wave, increasing central blood pressure (CBP). With normal aging, hypertension, and heart failure, increased wave velocity causes the reflected wave to reach the heart earlier, in mid to late systole, considerably increasing late-systolic load, impairing cardiac ejection, and diastolic relaxation in the ensuing cardiac cycle.
The magnitude of this reflected pressure wave can be quantified by the augmentation index (AIx). The use of vasoactive agents which antagonize this increase in late systolic load (and AIx) may prove useful in the treatment of heart failure, by facilitating cardiac ejection during late systole when reflected pressure waves predominate. However, it has never been conclusively shown in humans that CBP-targeted therapy is useful in the management of HF.
LV afterload, measured centrally in the ascending aorta, may differ considerably from brachial cuff-measured pressure, and has traditionally required invasive hemodynamic assessment to determine, limiting the applicability of techniques targeting CBP and late-systolic load. Recently, a novel, hand-held tonometer (SphygmoCor, Atcor Medical) has been developed for the noninvasive assessment of CBP. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure. This device has received FDA approval for clinical use in the assessment of central pressures. However, it remains unknown whether knowledge of CBP and late-systolic load (AIx) confers any clinically-significant incremental benefit in the management of patients with heart failure. The primary objective of the proposed investigation will be to determine if this assessment might have such a role.
Detailed description
Research Design and Methods
Hypotheses Knowledge of central aortic pressure waveforms (central pressure therapy, CPT) will affect the intensity of antihypertensive medication prescription, and treatment decisions based upon this knowledge in turn will lead to an enhanced reduction in CBP and AIx. Finally, it is hypothesized that this reduction in AIx/CBP will lead to improved exercise performance and LV systolic and diastolic reserve function.
Basic Study Plan This is a single-blind, randomized, controlled, parallel group intervention study examining the effects of a novel, noninvasive diagnostic test for determining AIx and CBP (SphygmoCor, Atcor Medical) on medical care, blood pressure control, exercise performance, and LV functional reserve in patients with chronic heart failure (HF) and systolic dysfunction (25%<EF<50%) and with preserved systolic function (EF>50%). Eligible subjects will undergo resting echocardiogram, noninvasive CBP assessment, and metabolic exercise stress testing on a recumbent cycle ergometer to quantify exercise performance. Echocardiography and CBP assessment will be performed at rest, during graded exercise, and immediately after peak exercise to determine indexes of LV systolic and diastolic performance and changes in CBP. Subjects will then be randomized (1:1) to subsequent determination of CBP at 1 month heart failure clinic visits versus sham (tonometry information acquired, but not shared with investigator). Investigators will then make adjustments to subject's medical therapy and antihypertensive regimen based upon the additional data procured via the Sphygmocor device. Subjects randomized to sham will have adjustments made as per standard clinical judgment based upon brachial blood pressure assessment and other clinical variables. In addition to standard clinical assessment, each subject will undergo 6 minute walk test at each visit, administered by the study coordinator.
At the 6 month follow up visit, subjects will undergo resting and exercise echo/CBP/metabolic stress testing exactly as performed at visit 1. The co-primary endpoints will be the change in central augmentation index (defined below) and change in peak oxygen uptake (VO2) from baseline. Secondary endpoints will include the changes in resting and exercise-induced CBP and brachial blood pressures, number of antihypertensive medications prescribed, resting and exercise change in LV systolic and diastolic function (see below), changes in: cardiac output, exercise time, anaerobic threshold, minute ventilation (VE) over carbon dioxide produced (VCO2) slope (ventilatory efficiency). There will be a total of 7 visits, the first and last for exercise testing; the intervening 5 visits will be routine heart failure clinic follow up appointments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SphygmoCor Unblinded | Active comparator | Device: SphygmoCorThe use of the sphygmocor values will determine medication adjustments to optimize HF treatment. |
| SphygmoCor Blinded | Placebo comparator | Device: SphygmoCorSphygmocor values will be blinded to the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or greater
- Cardiac Ejection Fraction (EF) greater than or equal to 25% by echocardiography within 12 months
- Stable New York Heart Association (NYHA) class II or greater
- Heart Failure consultation within the last 18 months
- Ability to exercise on a cycle ergometer
Key exclusion criteria (16 listed)
- Enrollment in a concurrent study that may confound the results of this study
- Subjects with medical conditions that would limit study participation
- Pregnancy
- Brachial Systolic Blood Pressure less than 110 mmHg
- Baseline AIx less than 15%
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 |
|---|---|---|
| SphygmoCorThe SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure. | Device | SphygmoCor Blinded, SphygmoCor Unblinded |
Primary outcome
Change in Peak Oxygen Uptake (VO2) During Maximal Effort Exercise Stress Test According to Ejection Fraction Subgroups
Time frame: baseline, 6 months
Peak oxygen uptake (VO2) is the maximum rate of oxygen consumption as measured during incremental exercise, most typically on a motorized treadmill. Maximal oxygen consumption reflects the aerobic physical fitness of the individual. VO2 data was obtained via standard breath-by-breath expired gas analysis. Ejection Fraction Subgroups are based on participants reported at baseline.
Change in Aortic Augmentation Index (AIx) According to Ejection Fraction Subgroups
Time frame: baseline, 6 months
Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx. Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx).
14 secondary outcomes
Change in Heart Rate
Time frame: baseline, six months
Change in Left Ventricle (LV) End Diastolic Volume
Time frame: baseline, 6 months
Change in LV End Systolic Volume
Time frame: baseline, 6 months
Change in LV Ejection Fraction
Time frame: baseline, 6 months
Change in Stroke Volume
Time frame: baseline, 6 months
Change in Mitral E Velocity
Time frame: baseline, 6 months
Change in Mitral E/A Ratio
Time frame: baseline, 6 months
Change in Mitral E Wave Deceleration Time
Time frame: baseline, 6 months
Change in Brachial Systolic Blood Pressure (BP)
Time frame: baseline, 6 months
Change in Brachial Diastolic BP
Time frame: baseline, 6 months
Change in Central Systolic BP
Time frame: baseline, 6 months
Change in Central Diastolic BP
Time frame: baseline, 6 months
Change in Augmentation Index
Time frame: baseline, 6 months
Change in Arterial Elastance
Time frame: baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28159826Wohlfahrt P, Melenovsky V, Redfield MM, Olson TP, Lin G, Abdelmoneim SS, Hametner B, Wassertheurer S, Borlaug BA. Aortic Waveform Analysis to Individualize Treatment in Heart Failure. Circ Heart Fail. 2017 Feb;10(2):e003516. doi: 10.1161/CIRCHEARTFAILURE.116.003516.
- Derived from this study: PubMed 24650926Borlaug BA, Olson TP, Abdelmoneim SS, Melenovsky V, Sorrell VL, Noonan K, Lin G, Redfield MM. A randomized pilot study of aortic waveform guided therapy in chronic heart failure. J Am Heart Assoc. 2014 Mar 20;3(2):e000745. doi: 10.1161/JAHA.113.000745.
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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.
Barry A. Borlaug, MD principal investigator
Staff Physician, Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SphygmoCor in people with Heart Failure, run by Mayo Clinic at 2 sites 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 16 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 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2014). 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?
Change in Peak Oxygen Uptake (VO2) During Maximal Effort Exercise Stress Test According to Ejection Fraction Subgroups (time frame: baseline, 6 months). The study lists 2 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 NCT00588692, 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 6 May 2014.