Study Summary
This trial is testing whether a patient specific, progressive home-based cardiac rehabilitation program delivered through an m-Health program can help improve functional status, exercise capacity, and quality of life in patients with heart failure with preserved ejection fraction.
Eligible Conditions
- Diastolic Heart Failure
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 3 months and 6 months
Month 6
6-minute walk distance
Change from baseline Standard physical performance battery score at 3 and 6 months
Quality of Life using Kansas City Cardiomyopathy Questionnaire (KCCQ) score
6 months
Peak VO2
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Usual care arm
1 of 2
m-health cardiac rehabilitation intervention arm
1 of 2
Active Control
Experimental Treatment
20 Total Participants · 2 Treatment Groups
Primary Treatment: m-health cardiac rehabilitation · No Placebo Group · N/A
m-health cardiac rehabilitation intervention arm
Other
Experimental Group · 1 Intervention: m-health cardiac rehabilitation · Intervention Types: OtherUsual care armNoIntervention Group · 1 Intervention: Usual care arm · Intervention Types:
Trial Logistics
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months and 6 months
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
971 Previous Clinical Trials
1,115,791 Total Patients Enrolled
16 Trials studying Heart Failure
12,517 Patients Enrolled for Heart Failure
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Connecticut | 100.0% |
What site did they apply to?
| UT Southwestern Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How many prior treatments have patients received?
| 1 | 100.0% |
References
- Packer, Milton, Michael B. Fowler, Ellen B. Roecker, Andrew J.S. Coats, Hugo A. Katus, Henry Krum, Paul Mohacsi, et al.. 2002. “Effect of Carvedilol on the Morbidity of Patients with Severe Chronic Heart Failure”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.cir.0000035653.72855.bf.
- Zannad, Faiez, John J.V. McMurray, Henry Krum, Dirk J. van Veldhuisen, Karl Swedberg, Harry Shi, John Vincent, Stuart J. Pocock, and Bertram Pitt. 2011. “Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1009492.
- McMurray, John J.V., Milton Packer, Akshay S. Desai, Jianjian Gong, Martin P. Lefkowitz, Adel R. Rizkala, Jean L. Rouleau, et al.. 2014. “Angiotensin–neprilysin Inhibition Versus Enalapril in Heart Failure”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1409077.
- McMurray, John J.V., Scott D. Solomon, Silvio E. Inzucchi, Lars Køber, Mikhail N. Kosiborod, Felipe A. Martinez, Piotr Ponikowski, et al.. 2019. “Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1911303.
- Lam, Carolyn S P, Adriaan A Voors, Rudolf A de Boer, Scott D Solomon, and Dirk J van Veldhuisen. 2018. “Heart Failure with Preserved Ejection Fraction: From Mechanisms to Therapies”. European Heart Journal. Oxford University Press (OUP). doi:10.1093/eurheartj/ehy301.
- Yancy, Clyde W., Mariell Jessup, Biykem Bozkurt, Javed Butler, Donald E. Casey Jr., Mark H. Drazner, Gregg C. Fonarow, et al.. 2013. “2013 ACCF/AHA Guideline for the Management of Heart Failure”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2013.05.019.
- Piña, Ileana L., Carl S. Apstein, Gary J. Balady, Romualdo Belardinelli, Bernard R. Chaitman, Brian D. Duscha, Barbara J. Fletcher, Jerome L. Fleg, Jonathan N. Myers, and Martin J. Sullivan. 2003. “Exercise and Heart Failure”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.cir.0000055013.92097.40.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Fletcher, Gerald F., Philip A. Ades, Paul Kligfield, Ross Arena, Gary J. Balady, Vera A. Bittner, Lola A. Coke, et al.. 2013. “Exercise Standards for Testing and Training”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0b013e31829b5b44.
- Lang, Roberto M., Luigi P. Badano, Victor Mor-Avi, Jonathan Afilalo, Anderson Armstrong, Laura Ernande, Frank A. Flachskampf, et al.. 2015. “Recommendations for Cardiac Chamber Quantification by Echocardiography in Adults: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging”. Journal of the American Society of Echocardiography. Elsevier BV. doi:10.1016/j.echo.2014.10.003.
- Nagueh, Sherif F., Otto A. Smiseth, Christopher P. Appleton, Benjamin F. Byrd III, Hisham Dokainish, Thor Edvardsen, Frank A. Flachskampf, et al.. 2016. “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”. Journal of the American Society of Echocardiography. Elsevier BV. doi:10.1016/j.echo.2016.01.011.
- Fletcher 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.
- Pina 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.
- 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.
- McMurray 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.
- Yancy 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.
- Nagueh 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.
- Lam 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. Erratum In: Eur Heart J. 2019 Feb 7;40(6):528.
- Ambarish Pandey 2021. "Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05002075.
Frequently Asked Questions
How many individuals have been chosen to participate in this research?
"Absolutely. Clinicaltrials.gov has the most recent information on this trial which was first posted on November 20th 2021 and is still actively recruiting participants. Currently, only one medical centre needs to enrol a total of twenty patients for the study." - Anonymous Online Contributor
Unverified Answer
Is this experiment still recruiting participants?
"Affirmative. The information from clinicaltrials.gov states that this research is currently enrolling candidates. This study was initially advertised on November 20th 2021 and has since been updated to reflect current findings as of November 30th 2022. It seeks to include a total of 20 patients across one location." - Anonymous Online Contributor
Unverified Answer