Heart Failure With Preserved Ejection FractionNCT05002075
Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction
A study testing m-health cardiac rehabilitation in people with Heart Failure With Preserved Ejection Fraction, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- m-health cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2021to 13 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age> 18 years
- HFpEF with left ventricular ejection fraction >50%
- Clinically stable and no hospitalization in last 4 weeks
- Estimated glomerular filtration rate > 45 mL/min/1.73 m2 as measured by the simplified MDRD formula
- Stable diuretic regimen
- SPPB <10 or historical (within 12 months) or current Peak (measured or estimated) VO2 <= 60% predicted value for age and gender.
Who cannot join
- History of cancer or end stage lung disease
- Estimated glomerular filtration rate < 45 mL/min/1.73 m2 as measured by the simplified MDRD formula
- Recent HF decompensation
- Inability to do exercise test
- Inability to provide written informed consent
- History of falls
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Controlled Trial
Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden and is projected to be the predominant subtype of HF in the near future. While multiple therapies have proven efficacious for patients with HFrEF, no pharmacological agents have demonstrably been shown to improve outcomes in HFpEF, highlighting the need for novel approaches to HFpEF treatment. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers. Home-based exercise using an m-Health platform is an alternative to supervised exercise that can deliver clinician prescribed exercise interventions and wellness education though monitoring and care coordination. The goal of this study is to evaluate the feasibility and efficacy of a patient specific progressive home-based cardiac rehabilitation program leveraging the technology of the m-Health program in improving functional status, exercise capacity, and QOL in patients with HFpEF.
Read the detailed description
Approximately 6.2 million adults in the United States suffer from heart failure (HF), of which almost one-half maintain a left ventricle ejection fraction (EF) >50% known as heart failure with preserved ejection fraction (HFpEF). The prevalence of HFpEF has been increasing as compared with HF with reduced ejection fraction (HFrEF) over time, particularly in older adults. HFpEF is associated with a high morbidity and mortality burden and remains recalcitrant to available pharmacotherapies, significantly highlighting the need for novel strategies for management. Emerging data suggests HFpEF is a multiorgan disease with complex pathophysiology culminating in debilitating exercise intolerance (EI). This key clinical manifestation of HFpEF, stems from multiple causal pathways: accelerated fitness decline with aging, high comorbidity burden, sarcopenia, impaired cardiovascular reserve, and skeletal muscle myopathy. EI demonstrated by dyspnea and fatigue cascades into functional deconditioning and reduced quality of life (QOL). In addition to EI, >90% of patients with HFpEF are pre-frail or frail and demonstrate physical function limitations. Unfortunately, these characteristic clinical findings in HFpEF are strongly predictive of death and hospitalization. There is an urgent need to develop effective therapeutic approaches targeting EI and physical function to achieve meaningful improvements in patient-reported and clinical outcomes in HFpEF.
Supervised exercise training has been shown to improve functional status, exercise capacity, quality of life (QOL), and lower risk of hospitalization in patients with HF with most studies conducted in the HFrEF population. Smaller trials have demonstrated significant improvements in exercise capacity and QOL with supervised exercise training in HFpEF.5 Accordingly, the AHA/ACC 2013 HF guidelines recommend exercise and cardiac rehabilitation (CR) for patients with chronic HF who can participate in exercise to improve QOL and functional status. Furthermore, a statement from the AHA committee on exercise, rehabilitation, and prevention recommends exercise intensity, duration, and frequency should be tailored to the individual needs of patients. In 2014, HFrEF became a reimbursable diagnosis for comprehensive cardiac rehabilitation (CR) but HFpEF was excluded due to lack of large-scale clinical end-point driven trial evidence. Despite the established benefits, CR is widely underutilized with <10% of eligible HF participants engaging in the same. CR participation barriers include comprehensive institutional expertise needed, widespread regulations, low reimbursement rates, high patient cost, patient time and travel, and facility requirement. Considering the benefits effects of exercise training on patient-oriented functional outcomes in HFpEF and the lack of availability of the current supervised exercise CR model (3 times/week x 12 weeks) for this patient population, there is a need for a more feasible, scalable, and cost-effective alternative approach to delivering exercise training.
Home-based CR using a m-Health platform is a novel alternative to supervised CR that can deliver clinician specific exercise interventions and CR wellness education with remote monitoring and care coordination. The feasibility and efficacy of home-based CR among patients with HFpEF have not been evaluated but have a critical potential impact for this population. This is particularly relevant given the focus on telehealth and home-based in the era of COVID-19. This represents a significant knowledge gap and opportunity considering the current clinical reality that patients with HFpEF have a high burden of physical function impairment and exercise intolerance, the previously reported benefits of exercise training in this patient population, and the current lack of therapeutic opportunities that can be feasibly implemented on a population scale.
Home-based CR with m-health platform is not the standard of care currently, but is an exploratory intervention.
- Being tested
- m-health cardiac rehabilitation
- Keywords
- HFpEF, Cardiac rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m-health cardiac rehabilitationOther
Participants randomized to m-Health cardiac rehabilitation will receive a 24-week home-based exercise program delivered via a previously validated, commercially available smartphone platform called Movn (Moving Analytics, California). This app includes a patient-facing iOS and Android compatible smartphone app and an integrated hospital-facing online dashboard for remote monitoring and care coordination by a trained coach
| Study group | Role | What they receive |
|---|---|---|
| Usual care arm | No intervention | Participants in the usual control group will receive standard of care per their providers' discretion. |
| m-health cardiac rehabilitation intervention arm | Experimental | Participants randomized to m-Health cardiac rehabilitation will receive a 24-week home-based exercise program Receives: Other: m-health cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Standard physical performance battery score at 3 and 6 months
SPPB score is a well-validated measure of physical function using 3 components: 4-m gait speed, time to complete 5 chair rises, and standing balance. Each component is scored on a 0-4 scale and summed for an overall score range of 0-12.
Measured: 3 months and 6 months
Secondary outcomes (3)
Peak VO2
Peak VO2 is a gold-standard measure of aerobic exercise capacity and will be measured by maximal exercise test using a previously established ergometer protocol
Measured: 6 months
6-minute walk distance
6-MWD is a simple and well-validated measure of submaximal exercise capacity and does not require any exercise equipment or advanced training for technicians
Measured: 3 months and 6 months
Quality of Life using Kansas City Cardiomyopathy Questionnaire (KCCQ) score
QOL will be assessed using the KCCQ score, which is a self-administered questionnaire that assesses a patient's perception of their heart failure with regard to the psychological, physical, and socioeconomic aspects of life. Minimum value is 0 and maximum value is 100. Lower scores means a worse outcome
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start20 Nov 2021
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ambarish Pandey, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002075
- Sponsor's protocol ID
- STU-2021-0329
- Status last verified
- May 2024
- First submitted
- 28 Jul 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Packer M, Fowler MB, Roecker EB, Coats AJ, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Staiger C, Holcslaw TL, Amann-Zalan I, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study Group. Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study. Circulation. 2002 Oct 22;106(17):2194-9. doi: 10.1161/01.cir.0000035653.72855.bf.
PubMed 12390947Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14.
PubMed 21073363McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.
PubMed 25176015McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
PubMed 31535829Lam CSP, Voors AA, de Boer RA, Solomon SD, van Veldhuisen DJ. Heart failure with preserved ejection fraction: from mechanisms to therapies. Eur Heart J. 2018 Aug 7;39(30):2780-2792. doi: 10.1093/eurheartj/ehy301.
PubMed 29905796Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
PubMed 23747642Pina IL, Apstein CS, Balady GJ, Belardinelli R, Chaitman BR, Duscha BD, Fletcher BJ, Fleg JL, Myers JN, Sullivan MJ; American Heart Association Committee on exercise, rehabilitation, and prevention. Exercise and heart failure: A statement from the American Heart Association Committee on exercise, rehabilitation, and prevention. Circulation. 2003 Mar 4;107(8):1210-25. doi: 10.1161/01.cir.0000055013.92097.40. No abstract available.
PubMed 12615804Pandey A, MacNamara J, Sarma S, Velasco F, Kannan V, Willard J, Skinner C, Keller T, Basit M, Levine B, Willett D. Rapid-Cycle Implementation of a Multi-Organization Registry for Heart Failure with Preserved Ejection Fraction Using Health Information Exchange Standards. Stud Health Technol Inform. 2019 Aug 21;264:1560-1561. doi: 10.3233/SHTI190534.
PubMed 31438231Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
PubMed 23877260Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
PubMed 25559473Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.
PubMed 27037982
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05002075
- Acronym / sponsor ID
- STU-2021-0329
- Keywords
- HFpEF, Cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 12 Aug 2021 (actual)
- 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.
Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden and is projected to be the predominant subtype of HF in the near future. While multiple therapies have proven efficacious for patients with HFrEF, no pharmacological agents have demonstrably been shown to improve outcomes in HFpEF, highlighting the need for novel approaches to HFpEF treatment. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers. Home-based exercise using an m-Health platform is an alternative to supervised exercise that can deliver clinician prescribed exercise interventions and wellness education though monitoring and care coordination. The goal of this study is to evaluate the feasibility and efficacy of a patient specific progressive home-based cardiac rehabilitation program leveraging the technology of the m-Health program in improving functional status, exercise capacity, and QOL in patients with HFpEF.
Detailed description
Approximately 6.2 million adults in the United States suffer from heart failure (HF), of which almost one-half maintain a left ventricle ejection fraction (EF) >50% known as heart failure with preserved ejection fraction (HFpEF). The prevalence of HFpEF has been increasing as compared with HF with reduced ejection fraction (HFrEF) over time, particularly in older adults. HFpEF is associated with a high morbidity and mortality burden and remains recalcitrant to available pharmacotherapies, significantly highlighting the need for novel strategies for management. Emerging data suggests HFpEF is a multiorgan disease with complex pathophysiology culminating in debilitating exercise intolerance (EI). This key clinical manifestation of HFpEF, stems from multiple causal pathways: accelerated fitness decline with aging, high comorbidity burden, sarcopenia, impaired cardiovascular reserve, and skeletal muscle myopathy. EI demonstrated by dyspnea and fatigue cascades into functional deconditioning and reduced quality of life (QOL). In addition to EI, >90% of patients with HFpEF are pre-frail or frail and demonstrate physical function limitations. Unfortunately, these characteristic clinical findings in HFpEF are strongly predictive of death and hospitalization. There is an urgent need to develop effective therapeutic approaches targeting EI and physical function to achieve meaningful improvements in patient-reported and clinical outcomes in HFpEF.
Supervised exercise training has been shown to improve functional status, exercise capacity, quality of life (QOL), and lower risk of hospitalization in patients with HF with most studies conducted in the HFrEF population. Smaller trials have demonstrated significant improvements in exercise capacity and QOL with supervised exercise training in HFpEF.5 Accordingly, the AHA/ACC 2013 HF guidelines recommend exercise and cardiac rehabilitation (CR) for patients with chronic HF who can participate in exercise to improve QOL and functional status. Furthermore, a statement from the AHA committee on exercise, rehabilitation, and prevention recommends exercise intensity, duration, and frequency should be tailored to the individual needs of patients. In 2014, HFrEF became a reimbursable diagnosis for comprehensive cardiac rehabilitation (CR) but HFpEF was excluded due to lack of large-scale clinical end-point driven trial evidence. Despite the established benefits, CR is widely underutilized with <10% of eligible HF participants engaging in the same. CR participation barriers include comprehensive institutional expertise needed, widespread regulations, low reimbursement rates, high patient cost, patient time and travel, and facility requirement. Considering the benefits effects of exercise training on patient-oriented functional outcomes in HFpEF and the lack of availability of the current supervised exercise CR model (3 times/week x 12 weeks) for this patient population, there is a need for a more feasible, scalable, and cost-effective alternative approach to delivering exercise training.
Home-based CR using a m-Health platform is a novel alternative to supervised CR that can deliver clinician specific exercise interventions and CR wellness education with remote monitoring and care coordination. The feasibility and efficacy of home-based CR among patients with HFpEF have not been evaluated but have a critical potential impact for this population. This is particularly relevant given the focus on telehealth and home-based in the era of COVID-19. This represents a significant knowledge gap and opportunity considering the current clinical reality that patients with HFpEF have a high burden of physical function impairment and exercise intolerance, the previously reported benefits of exercise training in this patient population, and the current lack of therapeutic opportunities that can be feasibly implemented on a population scale.
Home-based CR with m-health platform is not the standard of care currently, but is an exploratory intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care arm | No intervention | –Participants in the usual control group will receive standard of care per their providers' discretion. |
| m-health cardiac rehabilitation intervention arm | Experimental | Other: m-health cardiac rehabilitationParticipants randomized to m-Health cardiac rehabilitation will receive a 24-week home-based exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults age> 18 years
- HFpEF with left ventricular ejection fraction >50%
- Clinically stable and no hospitalization in last 4 weeks
- Estimated glomerular filtration rate > 45 mL/min/1.73 m2 as measured by the simplified MDRD formula
- Stable diuretic regimen
Key exclusion criteria (6 listed)
- History of cancer or end stage lung disease
- Estimated glomerular filtration rate < 45 mL/min/1.73 m2 as measured by the simplified MDRD formula
- Recent HF decompensation
- Inability to do exercise test
- Inability to provide written informed consent
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 |
|---|---|---|
| m-health cardiac rehabilitationParticipants randomized to m-Health cardiac rehabilitation will receive a 24-week home-based exercise program delivered via a previously validated, commercially available smartphone platform called Movn (Moving Analytics, California). This app includes a patient-facing iOS and Android compatible smartphone app and an integrated hospital-facing online dashboard for remote monitoring and care coordination by a trained coach | Other | m-health cardiac rehabilitation intervention arm |
Primary outcome
Change from baseline Standard physical performance battery score at 3 and 6 months
Time frame: 3 months and 6 months
SPPB score is a well-validated measure of physical function using 3 components: 4-m gait speed, time to complete 5 chair rises, and standing balance. Each component is scored on a 0-4 scale and summed for an overall score range of 0-12.
3 secondary outcomes
Peak VO2
Time frame: 6 months
6-minute walk distance
Time frame: 3 months and 6 months
Quality of Life using Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: 3 months and 6 months
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 16 May 2024.
- Background: PubMed 12390947Packer M, Fowler MB, Roecker EB, Coats AJ, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Staiger C, Holcslaw TL, Amann-Zalan I, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study Group. Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study. Circulation. 2002 Oct 22;106(17):2194-9. doi: 10.1161/01.cir.0000035653.72855.bf.
- Background: PubMed 21073363Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14.
- Background: PubMed 25176015McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.
- Background: PubMed 31535829McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
- Background: PubMed 29905796Lam CSP, Voors AA, de Boer RA, Solomon SD, van Veldhuisen DJ. Heart failure with preserved ejection fraction: from mechanisms to therapies. Eur Heart J. 2018 Aug 7;39(30):2780-2792. doi: 10.1093/eurheartj/ehy301.
- Background: PubMed 23747642Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
- Background: PubMed 12615804Pina IL, Apstein CS, Balady GJ, Belardinelli R, Chaitman BR, Duscha BD, Fletcher BJ, Fleg JL, Myers JN, Sullivan MJ; American Heart Association Committee on exercise, rehabilitation, and prevention. Exercise and heart failure: A statement from the American Heart Association Committee on exercise, rehabilitation, and prevention. Circulation. 2003 Mar 4;107(8):1210-25. doi: 10.1161/01.cir.0000055013.92097.40. No abstract available.
- Background: PubMed 31438231Pandey A, MacNamara J, Sarma S, Velasco F, Kannan V, Willard J, Skinner C, Keller T, Basit M, Levine B, Willett D. Rapid-Cycle Implementation of a Multi-Organization Registry for Heart Failure with Preserved Ejection Fraction Using Health Information Exchange Standards. Stud Health Technol Inform. 2019 Aug 21;264:1560-1561. doi: 10.3233/SHTI190534.
- Background: PubMed 23877260Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
- Background: PubMed 25559473Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
- Background: PubMed 27037982Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
ELEVATE-HFpEF Clinical Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing m-health cardiac rehabilitation in people with Heart Failure With Preserved Ejection Fraction, run by University of Texas Southwestern Medical Center 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 6 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 16 May 2024. 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?
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?
Change from baseline Standard physical performance battery score at 3 and 6 months (time frame: 3 months and 6 months). 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 NCT05002075, which also lists 11 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 16 May 2024.