Clinical trial NCT02179242: Study to Evaluate the Effectiveness of Cardiac Rehabilitation (Rehab) for Acute Decompensated Heart Failure Patients on 6 Minute Walk Test and Quality of Life
Official title: Randomized, Single Center Study to Determine if a Cardiac Rehabilitation Program Immediately Following Hospitalization Reduces Hospital Readmissions and Improves Quality of Life Outcomes in Heart Failure Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: cardiac rehab
heart failure
KCCQ
6 minute walk test
readmission
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the investigators' project is to determine if patients admitted with a primary diagnosis of heart failure to Sanford Health facilities in regional southeastern South Dakota demonstrate benefits in improvement in functional capacity, quality of life, and a reduction in hospital readmission rates from a cardiac rehab program immediately following a discharge for an acute decompensated heart failure diagnosis related inpatient hospitalization encounter. The investigators hypothesize that those that receive cardiac rehab will have improved quality of life and reduced readmission rates at 30 and 90 days.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Admitted with acute, decompensated heart failure
* Signed informed consent

Exclusion Criteria:

* Approved by Center for Medicare and Medicaid Services (CMS) to enroll in cardiac rehab
* Have an elective procedure that would interrupt their exercise program
* Unable to partake in an exercise program due to physical incapacities
* Pregnancy
* Unable to read and understand the consent form

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: 30 days
Secondary outcomes:
measure: Readmission
timeFrame: 30 days
measure: Readmission
timeFrame: 90 days
measure: KCCQ
timeFrame: 30 days
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Sanford Heart Hospital
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Orvar Jonsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davidson PM, Cockburn J, Newton PJ, Webster JK, Betihavas V, Howes L, Owensby DO. Can a heart failure-specific cardiac rehabilitation program decrease hospitalizations and improve outcomes in high-risk patients? Eur J Cardiovasc Prev Rehabil. 2010 Aug;17(4):393-402. doi: 10.1097/HJR.0b013e328334ea56.
citation: Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):e6-e245. doi: 10.1161/CIR.0b013e31828124ad. Epub 2012 Dec 12. No abstract available.
citation: Guazzi M, Dickstein K, Vicenzi M, Arena R. Six-minute walk test and cardiopulmonary exercise testing in patients with chronic heart failure: a comparative analysis on clinical and prognostic insights. Circ Heart Fail. 2009 Nov;2(6):549-55. doi: 10.1161/CIRCHEARTFAILURE.109.881326. Epub 2009 Sep 28.
citation: Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.
citation: Joseph SM, Novak E, Arnold SV, Jones PG, Khattak H, Platts AE, Davila-Roman VG, Mann DL, Spertus JA. Comparable performance of the Kansas City Cardiomyopathy Questionnaire in patients with heart failure with preserved and reduced ejection fraction. Circ Heart Fail. 2013 Nov;6(6):1139-46. doi: 10.1161/CIRCHEARTFAILURE.113.000359. Epub 2013 Oct 15.
citation: Sauser K, Spertus JA, Pierchala L, Davis E, Pang PS. Quality of life assessment for acute heart failure patients from emergency department presentation through 30 days after discharge: a pilot study with the Kansas City Cardiomyopathy Questionnaire. J Card Fail. 2014 Jan;20(1):18-22. doi: 10.1016/j.cardfail.2013.11.010. Epub 2013 Dec 1.
citation: Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J. 2007 Aug;154(2):260-6. doi: 10.1016/j.ahj.2007.01.041.