Cardiovascular DiseasesNCT00037349
Heart Rate Recovery and Mortality
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate whether impaired heart-rate recovery after exercise is a powerful and independent predictor of mortality. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2001to Feb 2004
- Phase
- Observational
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate whether impaired heart-rate recovery after exercise is a powerful and independent predictor of mortality.
Read the detailed description
BACKGROUND:
Although there has been considerable attention paid to the prognostic significance of the heart rate rise during exercise, only recently has it been noted that the heart rate fall after exercise, or "heart-rate recovery," may be an even more powerful predictor of outcome. Heart-rate recovery after exercise is a consequence of central reactivation of vagal tone. As impaired parasympathetic function has been associated with increased risk of death, the study tests the hypothesis that an impaired heart-rate recovery is a powerful and independent predictor of mortality.
DESIGN NARRATIVE:
The overall aim of this project was to use heart-rate recovery to substantially improve the prognostic value of the exercise test. The specific aims of this project were: 1) Derive biologically meaningful mathematical models of heart-rate recovery. Data from over 20,000 patients who had undergone exercise testing at Cleveland Clinic Foundation between 1990 and 1998 were used; all of these patients had had their tests performed on exercise workstations which recorded heart rates every 10 seconds during and after exercise. Heart-rate recovery measures were the difference between heart rate at peak exercise and heart rate at different points during recovery. Modeling was based on exponential families, using stepwise selection, bootstrapping, and information theory approaches. Correlates of different patterns of heart rate recovery were determined. 2) Using the results of modeling of heart-recovery derived from the work in Specific Aim 1, determined a prognostically defined optimal definition of abnormal heart rate recovery and demonstrated that an abnormal heart rate recovery was a powerful and independent predictor of mortality in diverse patient groups. Data from exercise tolerance tests of over 40,000 patients studied at the Cleveland Clinic Foundation between 1990 and 1999 were analyzed. Statistical methods used included the nonparametric Kaplan-Meier product limit method and the Cox proportional hazards model with bootstrap validation, which included use of the random forest technique. 3) Using completely parametric techniques, developed predictive survival models in which heart-rate recovery was included along with clinical data and other exercise findings, including exercise capacity and heart rate changes during exercise. The advantages of the parametric technique included: a) it allowed for modeling of nonproportional hazards that might permit differential strength of effect at different follow-up times for different sets of risk factors; b) it generated absolute risk, not just relative risk; and c) it permitted patient-specific prediction.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2002 (estimated)
- Study startMar 2001
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael Lauer, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037349
- Sponsor's protocol ID
- 1164
- Other IDs
- R01HL066004
- Status last verified
- Jan 2005
- First submitted
- 16 May 2002
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Lauer MS, Alexe S, Pothier Snader CE, Blackstone EH, Ishwaran H, Hammer PL. Use of the logical analysis of data method for assessing long-term mortality risk after exercise electrocardiography. Circulation. 2002 Aug 6;106(6):685-90. doi: 10.1161/01.cir.0000024410.15081.fd.
PubMed 12163428Pereira JJ, Lauer MS, Bashir M, Afridi I, Blackstone EH, Stewart WJ, McCarthy PM, Thomas JD, Asher CR; New Collective Author. Survival after aortic valve replacement for severe aortic stenosis with low transvalvular gradients and severe left ventricular dysfunction. J Am Coll Cardiol. 2002 Apr 17;39(8):1356-63. doi: 10.1016/s0735-1097(02)01759-x.
PubMed 11955855Watanabe J, Thamilarasan M, Blackstone EH, Thomas JD, Lauer MS. Heart rate recovery immediately after treadmill exercise and left ventricular systolic dysfunction as predictors of mortality: the case of stress echocardiography. Circulation. 2001 Oct 16;104(16):1911-6.
PubMed 11602493Lauer MS. Exercise testing for assessment of autonomic function. Am Heart J. 2002 Oct;144(4):580-2. doi: 10.1067/mhj.2002.124830. No abstract available.
PubMed 12360151Frolkis JP, Pothier CE, Blackstone EH, Lauer MS. Frequent ventricular ectopy after exercise as a predictor of death. N Engl J Med. 2003 Feb 27;348(9):781-90. doi: 10.1056/NEJMoa022353.
PubMed 12606732Shishehbor MH, Baker DW, Blackstone EH, Lauer MS. Association of educational status with heart rate recovery: a population-based propensity analysis. Am J Med. 2002 Dec 1;113(8):643-9. doi: 10.1016/s0002-9343(02)01324-4.
PubMed 12505114Lauer MS, Froelicher V. Abnormal heart-rate recovery after exercise. Lancet. 2002 Oct 12;360(9340):1176-7. doi: 10.1016/S0140-6736(02)11224-4. No abstract available.
PubMed 12387983Ellis K, Pothier CE, Blackstone EH, Lauer MS. Is systolic blood pressure recovery after exercise a predictor of mortality? Am Heart J. 2004 Feb;147(2):287-92. doi: 10.1016/j.ahj.2003.08.009.
PubMed 14760327Vivekananthan DP, Blackstone EH, Pothier CE, Lauer MS. Heart rate recovery after exercise is a predictor of mortality, independent of the angiographic severity of coronary disease. J Am Coll Cardiol. 2003 Sep 3;42(5):831-8. doi: 10.1016/s0735-1097(03)00833-7.
PubMed 12957428Cheng YJ, Lauer MS, Earnest CP, Church TS, Kampert JB, Gibbons LW, Blair SN. Heart rate recovery following maximal exercise testing as a predictor of cardiovascular disease and all-cause mortality in men with diabetes. Diabetes Care. 2003 Jul;26(7):2052-7. doi: 10.2337/diacare.26.7.2052.
PubMed 12832312Seshadri N, Gildea TR, McCarthy K, Pothier C, Kavuru MS, Lauer MS. Association of an abnormal exercise heart rate recovery with pulmonary function abnormalities. Chest. 2004 Apr;125(4):1286-91. doi: 10.1378/chest.125.4.1286.
PubMed 15078736Chen MS, Blackstone EH, Pothier CE, Lauer MS. Heart rate recovery and impact of myocardial revascularization on long-term mortality. Circulation. 2004 Nov 2;110(18):2851-7. doi: 10.1161/01.CIR.0000147539.39775.F4. Epub 2004 Oct 25.
PubMed 15505081Aktas MK, Ozduran V, Pothier CE, Lang R, Lauer MS. Global risk scores and exercise testing for predicting all-cause mortality in a preventive medicine program. JAMA. 2004 Sep 22;292(12):1462-8. doi: 10.1001/jama.292.12.1462.
PubMed 15383517Christopher Jones R, Pothier CE, Blackstone EH, Lauer MS. Prognostic importance of presenting symptoms in patients undergoing exercise testing for evaluation of known or suspected coronary disease. Am J Med. 2004 Sep 15;117(6):380-9. doi: 10.1016/j.amjmed.2004.06.004.
PubMed 15380494O'Neill JO, Young JB, Pothier CE, Lauer MS. Severe frequent ventricular ectopy after exercise as a predictor of death in patients with heart failure. J Am Coll Cardiol. 2004 Aug 18;44(4):820-6. doi: 10.1016/j.jacc.2004.02.063.
PubMed 15312865
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Recovery and Mortality
- ClinicalTrials.gov ID
- NCT00037349
- Acronym / sponsor ID
- 1164
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Mar 2001
- Study completion
- Feb 2004 (actual)
- First posted
- 17 May 2002 (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.
To investigate whether impaired heart-rate recovery after exercise is a powerful and independent predictor of mortality.
Detailed description
BACKGROUND:
Although there has been considerable attention paid to the prognostic significance of the heart rate rise during exercise, only recently has it been noted that the heart rate fall after exercise, or "heart-rate recovery," may be an even more powerful predictor of outcome. Heart-rate recovery after exercise is a consequence of central reactivation of vagal tone. As impaired parasympathetic function has been associated with increased risk of death, the study tests the hypothesis that an impaired heart-rate recovery is a powerful and independent predictor of mortality.
DESIGN NARRATIVE:
The overall aim of this project was to use heart-rate recovery to substantially improve the prognostic value of the exercise test. The specific aims of this project were: 1) Derive biologically meaningful mathematical models of heart-rate recovery. Data from over 20,000 patients who had undergone exercise testing at Cleveland Clinic Foundation between 1990 and 1998 were used; all of these patients had had their tests performed on exercise workstations which recorded heart rates every 10 seconds during and after exercise. Heart-rate recovery measures were the difference between heart rate at peak exercise and heart rate at different points during recovery. Modeling was based on exponential families, using stepwise selection, bootstrapping, and information theory approaches. Correlates of different patterns of heart rate recovery were determined. 2) Using the results of modeling of heart-recovery derived from the work in Specific Aim 1, determined a prognostically defined optimal definition of abnormal heart rate recovery and demonstrated that an abnormal heart rate recovery was a powerful and independent predictor of mortality in diverse patient groups. Data from exercise tolerance tests of over 40,000 patients studied at the Cleveland Clinic Foundation between 1990 and 1999 were analyzed. Statistical methods used included the nonparametric Kaplan-Meier product limit method and the Cox proportional hazards model with bootstrap validation, which included use of the random forest technique. 3) Using completely parametric techniques, developed predictive survival models in which heart-rate recovery was included along with clinical data and other exercise findings, including exercise capacity and heart rate changes during exercise. The advantages of the parametric technique included: a) it allowed for modeling of nonproportional hazards that might permit differential strength of effect at different follow-up times for different sets of risk factors; b) it generated absolute risk, not just relative risk; and c) it permitted patient-specific prediction.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 18 Feb 2016.
- Background: PubMed 12163428Lauer MS, Alexe S, Pothier Snader CE, Blackstone EH, Ishwaran H, Hammer PL. Use of the logical analysis of data method for assessing long-term mortality risk after exercise electrocardiography. Circulation. 2002 Aug 6;106(6):685-90. doi: 10.1161/01.cir.0000024410.15081.fd.
- Background: PubMed 11955855Pereira JJ, Lauer MS, Bashir M, Afridi I, Blackstone EH, Stewart WJ, McCarthy PM, Thomas JD, Asher CR; New Collective Author. Survival after aortic valve replacement for severe aortic stenosis with low transvalvular gradients and severe left ventricular dysfunction. J Am Coll Cardiol. 2002 Apr 17;39(8):1356-63. doi: 10.1016/s0735-1097(02)01759-x.
- Background: PubMed 11602493Watanabe J, Thamilarasan M, Blackstone EH, Thomas JD, Lauer MS. Heart rate recovery immediately after treadmill exercise and left ventricular systolic dysfunction as predictors of mortality: the case of stress echocardiography. Circulation. 2001 Oct 16;104(16):1911-6.
- Background: PubMed 12360151Lauer MS. Exercise testing for assessment of autonomic function. Am Heart J. 2002 Oct;144(4):580-2. doi: 10.1067/mhj.2002.124830. No abstract available.
- Background: PubMed 12606732Frolkis JP, Pothier CE, Blackstone EH, Lauer MS. Frequent ventricular ectopy after exercise as a predictor of death. N Engl J Med. 2003 Feb 27;348(9):781-90. doi: 10.1056/NEJMoa022353.
- Background: PubMed 12505114Shishehbor MH, Baker DW, Blackstone EH, Lauer MS. Association of educational status with heart rate recovery: a population-based propensity analysis. Am J Med. 2002 Dec 1;113(8):643-9. doi: 10.1016/s0002-9343(02)01324-4.
- Background: PubMed 12387983Lauer MS, Froelicher V. Abnormal heart-rate recovery after exercise. Lancet. 2002 Oct 12;360(9340):1176-7. doi: 10.1016/S0140-6736(02)11224-4. No abstract available.
- Background: PubMed 14760327Ellis K, Pothier CE, Blackstone EH, Lauer MS. Is systolic blood pressure recovery after exercise a predictor of mortality? Am Heart J. 2004 Feb;147(2):287-92. doi: 10.1016/j.ahj.2003.08.009.
- Background: PubMed 12957428Vivekananthan DP, Blackstone EH, Pothier CE, Lauer MS. Heart rate recovery after exercise is a predictor of mortality, independent of the angiographic severity of coronary disease. J Am Coll Cardiol. 2003 Sep 3;42(5):831-8. doi: 10.1016/s0735-1097(03)00833-7.
- Background: PubMed 12832312Cheng YJ, Lauer MS, Earnest CP, Church TS, Kampert JB, Gibbons LW, Blair SN. Heart rate recovery following maximal exercise testing as a predictor of cardiovascular disease and all-cause mortality in men with diabetes. Diabetes Care. 2003 Jul;26(7):2052-7. doi: 10.2337/diacare.26.7.2052.
- Background: PubMed 15078736Seshadri N, Gildea TR, McCarthy K, Pothier C, Kavuru MS, Lauer MS. Association of an abnormal exercise heart rate recovery with pulmonary function abnormalities. Chest. 2004 Apr;125(4):1286-91. doi: 10.1378/chest.125.4.1286.
- Background: PubMed 15505081Chen MS, Blackstone EH, Pothier CE, Lauer MS. Heart rate recovery and impact of myocardial revascularization on long-term mortality. Circulation. 2004 Nov 2;110(18):2851-7. doi: 10.1161/01.CIR.0000147539.39775.F4. Epub 2004 Oct 25.
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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.
Michael Lauer
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00037349, which also lists 16 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 18 Feb 2016.