Heart FailurePAL-HFNCT01589601
Palliative Care in Heart Failure
A study testing Usual heart failure care and Interdisciplinary palliative care in people with Heart Failure and Heart Diseases, run by Duke University at 1 site in United States.
Trial summary
The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- What is being tested?
- Usual heart failure care and Interdisciplinary palliative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duke University Hospital inpatient adults
- Hospitalization for acute decompensated heart failure
- Dyspnea (shortness of breath) at rest or minimal exertion plus at least 1 sign of volume overload
- Previous heart failure hospitalization within the past 1 year
- At significant risk of dying from heart failure in the next 6 months
- Anticipated discharge from hospital with anticipated ability to return to outpatient follow-up appointments
Who cannot join
- Are not an inpatient at Duke University Hospital
- Acute coronary syndrome within 30 days
- Cardiac resynchronization therapy (CRT) within the past 3 months or current plan to implant CRT device
- Active myocarditis, constrictive pericarditis
- Severe stenotic valvular disease amenable to surgical intervention
- Anticipated heart transplant or ventricular assist device within 6 months
Show all 11Show fewer
- Renal replacement therapy
- Non-cardiac terminal illness
- Women who are pregnant or planning to become pregnant
- Inability to comply with study protocol
- Are not proficient in the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: Palliative Care in Heart Failure (PAL-HF)
The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.
Read the detailed description
Heart failure currently affects over 5 million Americans. Symptomatic patients have a median life expectancy of less than 5 years and those with late-stage disease have 1-year mortality rates approaching 90%. Despite recent therapeutic advances that reduce morbidity and mortality, heart failure continues to cause enormous suffering. Patients with advanced disease suffer not only from the physical effects of the illness, but also from psychosocial and spiritual distress. In addition, heart failure costs more than $34 billion annually to the healthcare system and a disproportionate amount is spent on patients in the last 6 months of life when some of the treatments may be either ineffective or undesired. Selected patients are candidates for aggressive treatments such as cardiac transplantation or mechanical circulatory support, but the application of these therapies to the broader heart failure population is limited by resource scarcity and their untested usefulness in older patients with significant co-morbidities.
The progressive nature of heart failure coupled with high mortality rates and poor quality of life mandates greater attention to palliative care as a routine component of heart failure management. Patients with advanced heart failure, particularly the elderly and those with significant co-morbidities, ought to be ideal candidates for palliative care that aims to relieve suffering and improve quality of life. Yet, several challenges have limited the use of palliative care approaches in heart failure:
- Determination of Prognosis. Several validated multivariable models have been developed to predict survival, yet considerable uncertainty remains and physicians are frequently unsure whether they are caring for a patient near or far from the end of life. Patients have an even harder time and are typically overly optimistic about their survival relative to that observed or predicted by multivariable models.
- Timing of Implementation. This prognostic uncertainty and the highly variable disease trajectories of individual patients with heart failure pose a challenge as to when palliative care interventions ought to be implemented. The most appropriate time to introduce palliative care concepts, particularly with regard to end-of-life planning, remains undefined and is linked to patient prognosis and preferences.
- Untested Interventions. There is limited evidence from randomized controlled trials of palliative care interventions in heart failure and the majority focus on resuscitation preferences. Further, practice guidelines from major cardiovascular societies are limited on this subject.
- Lack of Palliative Care Training of Cardiovascular Specialists . The education of cardiovascular specialists typically excludes formalized training in the principles and practice of palliative care.
Given these limitations, a properly designed and powered study is required to determine whether a multidimensional palliative care intervention in addition to usual care improves health-related outcomes relative to usual care alone in advanced heart failure patients with a highly probable short-term mortality.
PAL-HF is prospective, controlled, unblinded, 2-arm, single-center clinical trial of approximately 200 advanced heart failure patients with >50% predicted 6-month mortality randomized to usual, state of the art heart failure care or usual care combined with the PAL-HF intervention.
Patients will be randomized in a 1:1 ratio to either of 2 treatment regimens:
- Usual advanced HF care
- Usual advanced HF care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
The primary endpoint will be health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale (FACIT-Pal) score at 6 months
The duration of the intervention in PAL-HF is 6 months, but patients in both groups will be followed until death, or the end of the study.
The study will be completed in both arms of the trial with a post-death interview with the caregiver.
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- Being tested
- Usual heart failure care, Interdisciplinary palliative care
- Keywords
- Congestive Heart Failure, Heart Failure, Palliative Care, Palliative Medicine
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual heart failure careBehavioural
Also called Palliative Care, Palliative Medicine, Supportive Care
Usual heart failure care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
Interdisciplinary palliative careBehavioural
Interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
| Study group | Role | What they receive |
|---|---|---|
| Usual heart failure care | No intervention | Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function. |
| Usual care + palliative care | Active comparator | Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning. Receives: Behavioral: Usual heart failure care; Behavioral: Interdisciplinary palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
The primary endpoint is health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
The KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status.
Measured: Baseline, 6 months
Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)
The primary endpoint is health-related quality of life as measured by the FACIT-Pal.
The FACIT-Pal is a 46-item measure of self-reported quality of life (27 general quality of life; 19 palliative care) that assesses quality of life in several domains. The range of FACIT-Pal total score is 0-184, a higher score is better.
Measured: Baseline, 6 months
Secondary outcomes (5)
Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
Depression and anxiety will be assessed in all patients using the self-administered Hospital Anxiety and Depression Scale (HADS) at 2 weeks, 3 months, and 6 months.
Range of HADS total score is 0-42. It is divided into depression and anxiety. Each is 0-21. A score of 11 or higher indicates the possible presence of the mood disorder (clinical caseness) with a score of 8 to 10 being suggestive of the presence of the respective state. The two subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS in this study is divided into 3 ranges: normal (0-7), borderline (8-10), abnormal (11-21). Movement between categories would constitute a clinically significant change in the health status.
Measured: Baseline (2 weeks post hospital discharge), 3 months, 6 months
After-Death Bereaved Family Member Interview - Hospice Version
A structured interview with the caregiver of those subjects that die during the study will be conducted 6 weeks following the study subject's death using the After-Death Bereaved Family Member Interview - Hospice Version. The interview provides an assessment of patient-focused, family-centered care and assesses overall quality of care received. An overall rating is derived from the ratings questions. The scoring is calculated using a pre-formatted Microsoft Excel spreadsheet for data entry and analysis. For scoring, the 5 rating questions were summed and the final scale varied between 0 (indicating worst possible care) to 50 (best possible care).
Measured: 6 weeks after patient's death
Change in FACIT-Sp
Spiritual well-being will be assessed using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp) at 2 weeks, 3 months, and 6 months. The FACIT-Sp is a 12 item scale which assesses the role of faith in illness and meaning, peace, and purpose in life. The range of FACIT-Sp 12 score is 0-48, with higher values representing an increased spirituality across the range of religious traditions.
Measured: Baseline (2 weeks post hospital discharge), 3 months, 6 months
Utilization and Cost Measured by the Aggregate Cost of Care
The investigators will use administrative data from Duke Health System to estimate costs of care to determine the cost effectiveness of palliative care versus normal care. At all follow-up points in the study (2 weeks, 6 weeks, 3 months, 6 months, and every 6 months thereafter), patients will be asked if they received care outside of the Duke Health System and to estimate the number of physician visits and/or days in the hospital. The cost of such care will be estimated using the Medical Expenditure Panel Survey and included in the aggregate cost of care from randomization until completion of the study.
Due to administrative delays, constraints and time to access the cost data, the study team is still working through the data aggregation for full utilization comparison as well as cost comparison.
Measured: time of randomization until end of follow-up, approximately 3.5 years
Utilization and Cost Measured by Hospital Readmissions
We evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care.
Measured: Baseline (2 weeks post hospital discharge), 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2016
- Study completionFeb 2016
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 FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Joseph G. Rogers, MD, Principal investigator, Duke University Medical Center - DCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589601
- Sponsor's protocol ID
- Pro00032443
- Other IDs
- R01NR013428
- Acronym
- PAL-HF
- Status last verified
- Aug 2019
- First submitted
- 24 Apr 2012
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hayden D, Pauler DK, Schoenfeld D. An estimator for treatment comparisons among survivors in randomized trials. Biometrics. 2005 Mar;61(1):305-10. doi: 10.1111/j.0006-341X.2005.030227.x.
PubMed 15737107Tobin RS, Samsky MD, Kuchibhatla M, O'Connor CM, Fiuzat M, Warraich HJ, Anstrom KJ, Granger BB, Mark DB, Tulsky JA, Rogers JG, Mentz RJ, Johnson KS. Race Differences in Quality of Life following a Palliative Care Intervention in Patients with Advanced Heart Failure: Insights from the Palliative Care in Heart Failure Trial. J Palliat Med. 2022 Feb;25(2):296-300. doi: 10.1089/jpm.2021.0220. Epub 2021 Dec 1.
PubMed 34851740Truby LK, O'Connor C, Fiuzat M, Stebbins A, Coles A, Patel CB, Granger B, Pagidipati N, Agarwal R, Rymer J, Lowenstern A, Douglas PS, Tulsky J, Rogers JG, Mentz RJ. Sex Differences in Quality of Life and Clinical Outcomes in Patients With Advanced Heart Failure: Insights From the PAL-HF Trial. Circ Heart Fail. 2020 Apr;13(4):e006134. doi: 10.1161/CIRCHEARTFAILURE.119.006134. Epub 2020 Apr 9.
PubMed 32268795Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030.
PubMed 28705314Mentz RJ, Tulsky JA, Granger BB, Anstrom KJ, Adams PA, Dodson GC, Fiuzat M, Johnson KS, Patel CB, Steinhauser KE, Taylor DH Jr, O'Connor CM, Rogers JG. The palliative care in heart failure trial: rationale and design. Am Heart J. 2014 Nov;168(5):645-651.e1. doi: 10.1016/j.ahj.2014.07.018. Epub 2014 Jul 30.
PubMed 25440791
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care in Heart Failure (PAL-HF)
- ClinicalTrials.gov ID
- NCT01589601
- Acronym / sponsor ID
- PAL-HF / Pro00032443
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- Keywords
- Congestive Heart Failure, Heart Failure, Palliative Care, Palliative Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Aug 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Posted 24 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.
Detailed description
Heart failure currently affects over 5 million Americans. Symptomatic patients have a median life expectancy of less than 5 years and those with late-stage disease have 1-year mortality rates approaching 90%. Despite recent therapeutic advances that reduce morbidity and mortality, heart failure continues to cause enormous suffering. Patients with advanced disease suffer not only from the physical effects of the illness, but also from psychosocial and spiritual distress. In addition, heart failure costs more than $34 billion annually to the healthcare system and a disproportionate amount is spent on patients in the last 6 months of life when some of the treatments may be either ineffective or undesired. Selected patients are candidates for aggressive treatments such as cardiac transplantation or mechanical circulatory support, but the application of these therapies to the broader heart failure population is limited by resource scarcity and their untested usefulness in older patients with significant co-morbidities.
The progressive nature of heart failure coupled with high mortality rates and poor quality of life mandates greater attention to palliative care as a routine component of heart failure management. Patients with advanced heart failure, particularly the elderly and those with significant co-morbidities, ought to be ideal candidates for palliative care that aims to relieve suffering and improve quality of life. Yet, several challenges have limited the use of palliative care approaches in heart failure:
- Determination of Prognosis. Several validated multivariable models have been developed to predict survival, yet considerable uncertainty remains and physicians are frequently unsure whether they are caring for a patient near or far from the end of life. Patients have an even harder time and are typically overly optimistic about their survival relative to that observed or predicted by multivariable models.
- Timing of Implementation. This prognostic uncertainty and the highly variable disease trajectories of individual patients with heart failure pose a challenge as to when palliative care interventions ought to be implemented. The most appropriate time to introduce palliative care concepts, particularly with regard to end-of-life planning, remains undefined and is linked to patient prognosis and preferences.
- Untested Interventions. There is limited evidence from randomized controlled trials of palliative care interventions in heart failure and the majority focus on resuscitation preferences. Further, practice guidelines from major cardiovascular societies are limited on this subject.
- Lack of Palliative Care Training of Cardiovascular Specialists . The education of cardiovascular specialists typically excludes formalized training in the principles and practice of palliative care.
Given these limitations, a properly designed and powered study is required to determine whether a multidimensional palliative care intervention in addition to usual care improves health-related outcomes relative to usual care alone in advanced heart failure patients with a highly probable short-term mortality.
PAL-HF is prospective, controlled, unblinded, 2-arm, single-center clinical trial of approximately 200 advanced heart failure patients with >50% predicted 6-month mortality randomized to usual, state of the art heart failure care or usual care combined with the PAL-HF intervention.
Patients will be randomized in a 1:1 ratio to either of 2 treatment regimens:
- Usual advanced HF care
- Usual advanced HF care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
The primary endpoint will be health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale (FACIT-Pal) score at 6 months
The duration of the intervention in PAL-HF is 6 months, but patients in both groups will be followed until death, or the end of the study.
The study will be completed in both arms of the trial with a post-death interview with the caregiver.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual heart failure care | No intervention | –Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function. |
| Usual care + palliative care | Active comparator | Behavioral: Usual heart failure care, Behavioral: Interdisciplinary palliative carePatients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Duke University Hospital inpatient adults
- Hospitalization for acute decompensated heart failure
- Dyspnea (shortness of breath) at rest or minimal exertion plus at least 1 sign of volume overload
- Previous heart failure hospitalization within the past 1 year
- At significant risk of dying from heart failure in the next 6 months
Key exclusion criteria (11 listed)
- Are not an inpatient at Duke University Hospital
- Acute coronary syndrome within 30 days
- Cardiac resynchronization therapy (CRT) within the past 3 months or current plan to implant CRT device
- Active myocarditis, constrictive pericarditis
- Severe stenotic valvular disease amenable to surgical intervention
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 |
|---|---|---|
| Usual heart failure careAlso: Palliative Care, Palliative Medicine, Supportive CareUsual heart failure care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention. | Behavioural | Usual care + palliative care |
| Interdisciplinary palliative careInterdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention. | Behavioural | Usual care + palliative care |
Primary outcome
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline, 6 months
The primary endpoint is health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status.
Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)
Time frame: Baseline, 6 months
The primary endpoint is health-related quality of life as measured by the FACIT-Pal. The FACIT-Pal is a 46-item measure of self-reported quality of life (27 general quality of life; 19 palliative care) that assesses quality of life in several domains. The range of FACIT-Pal total score is 0-184, a higher score is better.
5 secondary outcomes
Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
Time frame: Baseline (2 weeks post hospital discharge), 3 months, 6 months
After-Death Bereaved Family Member Interview - Hospice Version
Time frame: 6 weeks after patient's death
Change in FACIT-Sp
Time frame: Baseline (2 weeks post hospital discharge), 3 months, 6 months
Utilization and Cost Measured by the Aggregate Cost of Care
Time frame: time of randomization until end of follow-up, approximately 3.5 years
Utilization and Cost Measured by Hospital Readmissions
Time frame: Baseline (2 weeks post hospital discharge), 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15737107Hayden D, Pauler DK, Schoenfeld D. An estimator for treatment comparisons among survivors in randomized trials. Biometrics. 2005 Mar;61(1):305-10. doi: 10.1111/j.0006-341X.2005.030227.x.
- Derived from this study: PubMed 34851740Tobin RS, Samsky MD, Kuchibhatla M, O'Connor CM, Fiuzat M, Warraich HJ, Anstrom KJ, Granger BB, Mark DB, Tulsky JA, Rogers JG, Mentz RJ, Johnson KS. Race Differences in Quality of Life following a Palliative Care Intervention in Patients with Advanced Heart Failure: Insights from the Palliative Care in Heart Failure Trial. J Palliat Med. 2022 Feb;25(2):296-300. doi: 10.1089/jpm.2021.0220. Epub 2021 Dec 1.
- Derived from this study: PubMed 32268795Truby LK, O'Connor C, Fiuzat M, Stebbins A, Coles A, Patel CB, Granger B, Pagidipati N, Agarwal R, Rymer J, Lowenstern A, Douglas PS, Tulsky J, Rogers JG, Mentz RJ. Sex Differences in Quality of Life and Clinical Outcomes in Patients With Advanced Heart Failure: Insights From the PAL-HF Trial. Circ Heart Fail. 2020 Apr;13(4):e006134. doi: 10.1161/CIRCHEARTFAILURE.119.006134. Epub 2020 Apr 9.
- Derived from this study: PubMed 28705314Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030.
- Derived from this study: PubMed 25440791Mentz RJ, Tulsky JA, Granger BB, Anstrom KJ, Adams PA, Dodson GC, Fiuzat M, Johnson KS, Patel CB, Steinhauser KE, Taylor DH Jr, O'Connor CM, Rogers JG. The palliative care in heart failure trial: rationale and design. Am Heart J. 2014 Nov;168(5):645-651.e1. doi: 10.1016/j.ahj.2014.07.018. Epub 2014 Jul 30.
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 3
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
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.
Joseph G. Rogers, MD principal investigator
Duke University Medical Center - DCRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual heart failure care and Interdisciplinary palliative care in people with Heart Failure and Heart Diseases, run by Duke 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 6 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 28 Aug 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 24 Jul 2017). 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?
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. 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 NCT01589601, 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 28 Aug 2019.