Heart Failure, DiastolicSECRETNCT00959660
Exercise Intolerance in Elderly Patients With Diastolic Heart Failure
A study testing Exercise, Dietary Intervention and Diet and exercise in people with Heart Failure, Diastolic and Obesity, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with heart failure and a normal ejection fraction (HFNEF) and body mass index greater than or equal to 30. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure, Diastolic, Obesity
- What is being tested?
- Exercise, Dietary Intervention and Diet and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure clinical score greater than or equal to 3
- Age 60 and over
- Normal ejection fraction greater than or equal to 50%
- BMI greater than or equal to 30
Who cannot join
- Valvular heart disease
- Significant change in cardiac medication <4 weeks
- Uncontrolled hypertension
- Recent or debilitating stroke
- Cancer or other noncardiovascular conditions with life expectancy less than 2 years
- Significant Anemia
Show all 11Show fewer
- Renal insufficiency (creatinine >2.5mg/dl)
- Psychiatric disease- uncontrolled major psychoses, depressions, dementia, or personality disorder
- Plans to leave area within 6 months
- Refuses informed consent
- Failure to pass screening test:pulmonary function, echocardiogram,or exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 271757
About this study
Official title: Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET)
The purpose of this study is to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with heart failure and a normal ejection fraction (HFNEF) and body mass index greater than or equal to 30.
Read the detailed description
Heart failure with a normal ejection fraction (HFNEF, previously termed diastolic heart failure), accounts for the majority of heart failure cases in the population > 65 years old and has been recognized as a true geriatric syndrome. Exercise intolerance is the primary chronic symptom of HFNEF and a major determinant of these patients' severely reduced quality of life; however little is known regarding its pathophysiology and treatment. Therefore, our work has focused on understanding the pathophysiology of exercise intolerance in HFNEF and developing and testing interventions that may improve this pivotal outcome in this highly prevalent disorder of older persons. The aims of the proposed study are to conduct a randomized, controlled, single-blinded, 2x2 design trial to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with HFNEF and body mass index >30 in order to test the following hypotheses: 1) Both weight loss and exercise training will improve exercise intolerance and quality of life in older, obese patients with HFNEF; 2) The combination of weight loss and exercise training will produce complementary effects on body and thigh muscle composition and additive improvements in exercise intolerance in HFNEF; 3) Improvements in exercise intolerance will correlate with improvements in lean body mass, reversal of adverse thigh muscle remodeling, and increased thigh muscle capillarity. The study has the potential to significantly advance our understanding of exercise intolerance and its treatment in the large population of older persons with HFNEF.
- Conditions
- Heart Failure, Diastolic, Obesity
- Being tested
- Exercise, Dietary Intervention, Diet and exercise, Attention Control
- Keywords
- Diastolic heart failure, Heart Failure, Elderly, Obesity
- Medical subject headings
- Heart Failure, Diastolic, Obesity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
walking, treadmill and bicycle exercise
Dietary InterventionDietary supplement
Subjects will be provided meals and instructions for individual food selections.
Diet and exerciseBehavioural
Subjects will be provided meals and instructions for individual food selections and will undergo walking, treadmill and bicycle exercise.
Attention ControlOther
control group- continue their previously randomized life style
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Active comparator | Exercise participants will undergo a 1-hour supervised exercise program 3 times per week for 20 weeks consisting primarily of walking exercise using an individualized exercise prescription based on the initial exercise stress testing results. Receives: Behavioral: Exercise |
| Dietary Intervention | Active comparator | A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week. Receives: Dietary Supplement: Dietary Intervention |
| Attention control | Active comparator | Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status. Receives: Other: Attention Control |
| Diet and Exercise | Active comparator | A hypocaloric diet will be developed to achieve a 2450 kcal/week deficit in addition to undergoing a 1-hour supervised exercise program 3 times per week for 20 weeks consisting primarily of walking exercise using an individualized exercise prescription based on the initial exercise stress testing results. Receives: Behavioral: Exercise; Behavioral: Diet and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Exercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion.
Measured: 20 weeks
Secondary outcomes (3)
Quality of Life
Heart failure-specific quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a range 0-100; higher scores indicate better quality of life.
Measured: 20 weeks
Body Composition
Total Body Fat Mass and Total Non-bone Lean Mass via DEXA
Measured: 20 weeks
Thigh Muscle Composition
Thigh Skeletal Muscle and Subcutaneous Fat via MRI
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startFeb 2009
- Primary completion15 Aug 2012
- Study completionAug 2013
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 (5)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, DiastolicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Dalane W Kitzman, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959660
- Sponsor's protocol ID
- IRB00005668
- Other IDs
- R37AG018915
- Acronym
- SECRET
- Status last verified
- Feb 2019
- First submitted
- 14 Aug 2009
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Singleton MJ, Nelson MB, Samuel TJ, Kitzman DW, Brubaker P, Haykowsky MJ, Upadhya B, Chen H, Nelson MD. Left Atrial Stiffness Index Independently Predicts Exercise Intolerance and Quality of Life in Older, Obese Patients With Heart Failure With Preserved Ejection Fraction. J Card Fail. 2022 Apr;28(4):567-575. doi: 10.1016/j.cardfail.2021.10.010. Epub 2021 Nov 10.
PubMed 34774747Anderson T, Cascino TM, Koelling TM, Perry D, Grafton G, Houston DK, Upadhya B, Kitzman DW, Hummel SL. Measured Versus Estimated Resting Metabolic Rate in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2021 Aug;14(8):e007962. doi: 10.1161/CIRCHEARTFAILURE.120.007962. Epub 2021 Aug 4.
PubMed 34344169Haykowsky MJ, Nicklas BJ, Brubaker PH, Hundley WG, Brinkley TE, Upadhya B, Becton JT, Nelson MD, Chen H, Kitzman DW. Regional Adipose Distribution and its Relationship to Exercise Intolerance in Older Obese Patients Who Have Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2018 Aug;6(8):640-649. doi: 10.1016/j.jchf.2018.06.002. Epub 2018 Jul 11.
PubMed 30007558Maldonado-Martin S, Brubaker PH, Eggebeen J, Stewart KP, Kitzman DW. Association Between 6-Minute Walk Test Distance and Objective Variables of Functional Capacity After Exercise Training in Elderly Heart Failure Patients With Preserved Ejection Fraction: A Randomized Exercise Trial. Arch Phys Med Rehabil. 2017 Mar;98(3):600-603. doi: 10.1016/j.apmr.2016.08.481. Epub 2016 Sep 28.
PubMed 27693420Kitzman DW, Brubaker P, Morgan T, Haykowsky M, Hundley G, Kraus WE, Eggebeen J, Nicklas BJ. Effect of Caloric Restriction or Aerobic Exercise Training on Peak Oxygen Consumption and Quality of Life in Obese Older Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Jan 5;315(1):36-46. doi: 10.1001/jama.2015.17346.
PubMed 26746456
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET)
- ClinicalTrials.gov ID
- NCT00959660
- Acronym / sponsor ID
- SECRET / IRB00005668
- Conditions
- Heart Failure, Diastolic, Obesity
- Keywords
- Diastolic heart failure, Heart Failure, Elderly, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Feb 2009 (actual)
- Primary completion
- 15 Aug 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Posted 11 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with heart failure and a normal ejection fraction (HFNEF) and body mass index greater than or equal to 30.
Detailed description
Heart failure with a normal ejection fraction (HFNEF, previously termed diastolic heart failure), accounts for the majority of heart failure cases in the population > 65 years old and has been recognized as a true geriatric syndrome. Exercise intolerance is the primary chronic symptom of HFNEF and a major determinant of these patients' severely reduced quality of life; however little is known regarding its pathophysiology and treatment. Therefore, our work has focused on understanding the pathophysiology of exercise intolerance in HFNEF and developing and testing interventions that may improve this pivotal outcome in this highly prevalent disorder of older persons. The aims of the proposed study are to conduct a randomized, controlled, single-blinded, 2x2 design trial to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with HFNEF and body mass index >30 in order to test the following hypotheses: 1) Both weight loss and exercise training will improve exercise intolerance and quality of life in older, obese patients with HFNEF; 2) The combination of weight loss and exercise training will produce complementary effects on body and thigh muscle composition and additive improvements in exercise intolerance in HFNEF; 3) Improvements in exercise intolerance will correlate with improvements in lean body mass, reversal of adverse thigh muscle remodeling, and increased thigh muscle capillarity. The study has the potential to significantly advance our understanding of exercise intolerance and its treatment in the large population of older persons with HFNEF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Active comparator | Behavioral: ExerciseExercise participants will undergo a 1-hour supervised exercise program 3 times per week for 20 weeks consisting primarily of walking exercise using an individualized exercise prescription based on the initial exercise stress testing results. |
| Dietary Intervention | Active comparator | Dietary Supplement: Dietary InterventionA hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week. |
| Attention control | Active comparator | Other: Attention ControlAttention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status. |
| Diet and Exercise | Active comparator | Behavioral: Exercise, Behavioral: Diet and exerciseA hypocaloric diet will be developed to achieve a 2450 kcal/week deficit in addition to undergoing a 1-hour supervised exercise program 3 times per week for 20 weeks consisting primarily of walking exercise using an individualized exercise prescription based on the initial exercise stress testing results. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Heart failure clinical score greater than or equal to 3
- Age 60 and over
- Normal ejection fraction greater than or equal to 50%
- BMI greater than or equal to 30
Key exclusion criteria (11 listed)
- Valvular heart disease
- Significant change in cardiac medication <4 weeks
- Uncontrolled hypertension
- Recent or debilitating stroke
- Cancer or other noncardiovascular conditions with life expectancy less than 2 years
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 |
|---|---|---|
| Exercisewalking, treadmill and bicycle exercise | Behavioural | Diet and Exercise, Exercise Training |
| Dietary InterventionSubjects will be provided meals and instructions for individual food selections. | Dietary supplement | Dietary Intervention |
| Diet and exerciseSubjects will be provided meals and instructions for individual food selections and will undergo walking, treadmill and bicycle exercise. | Behavioural | Diet and Exercise |
| Attention Controlcontrol group- continue their previously randomized life style | Other | Attention control |
Primary outcome
Exercise Capacity
Time frame: 20 weeks
Exercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion.
3 secondary outcomes
Quality of Life
Time frame: 20 weeks
Body Composition
Time frame: 20 weeks
Thigh Muscle Composition
Time frame: 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34774747Singleton MJ, Nelson MB, Samuel TJ, Kitzman DW, Brubaker P, Haykowsky MJ, Upadhya B, Chen H, Nelson MD. Left Atrial Stiffness Index Independently Predicts Exercise Intolerance and Quality of Life in Older, Obese Patients With Heart Failure With Preserved Ejection Fraction. J Card Fail. 2022 Apr;28(4):567-575. doi: 10.1016/j.cardfail.2021.10.010. Epub 2021 Nov 10.
- Derived from this study: PubMed 34344169Anderson T, Cascino TM, Koelling TM, Perry D, Grafton G, Houston DK, Upadhya B, Kitzman DW, Hummel SL. Measured Versus Estimated Resting Metabolic Rate in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2021 Aug;14(8):e007962. doi: 10.1161/CIRCHEARTFAILURE.120.007962. Epub 2021 Aug 4.
- Derived from this study: PubMed 30007558Haykowsky MJ, Nicklas BJ, Brubaker PH, Hundley WG, Brinkley TE, Upadhya B, Becton JT, Nelson MD, Chen H, Kitzman DW. Regional Adipose Distribution and its Relationship to Exercise Intolerance in Older Obese Patients Who Have Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2018 Aug;6(8):640-649. doi: 10.1016/j.jchf.2018.06.002. Epub 2018 Jul 11.
- Derived from this study: PubMed 27693420Maldonado-Martin S, Brubaker PH, Eggebeen J, Stewart KP, Kitzman DW. Association Between 6-Minute Walk Test Distance and Objective Variables of Functional Capacity After Exercise Training in Elderly Heart Failure Patients With Preserved Ejection Fraction: A Randomized Exercise Trial. Arch Phys Med Rehabil. 2017 Mar;98(3):600-603. doi: 10.1016/j.apmr.2016.08.481. Epub 2016 Sep 28.
- Derived from this study: PubMed 26746456Kitzman DW, Brubaker P, Morgan T, Haykowsky M, Hundley G, Kraus WE, Eggebeen J, Nicklas BJ. Effect of Caloric Restriction or Aerobic Exercise Training on Peak Oxygen Consumption and Quality of Life in Obese Older Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Jan 5;315(1):36-46. doi: 10.1001/jama.2015.17346.
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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.
Dalane W Kitzman, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Dietary Intervention and Diet and exercise in people with Heart Failure, Diastolic and Obesity, run by Wake Forest University at 1 site 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 4 inclusion and 11 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 15 Feb 2019. 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 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. 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 11 Apr 2018). 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?
Exercise Capacity (time frame: 20 weeks). 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 NCT00959660, which also lists 5 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 15 Feb 2019.