Heart FailureGOURMET-HFNCT02148679
Geriatric Out of Hospital Randomized Meal Trial in Heart Failure
A study testing DASH/SRD in people with Heart Failure, run by University of Michigan at 3 sites in United States.
Trial summary
Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- DASH/SRD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2014to Jul 2017
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 66 male and female patients aged ≥ 55 years with history of systemic hypertension and acutely decompensated heart failure (ADHF; primary diagnosis for admission or secondary diagnosis after hospitalization for another reason). ADHF will be confirmed by the study physician and defined as a combination of symptoms, signs, and HF-specific medical treatments. Specifically, ADHF will require that all four of the following conditions are met:
- ≥1 symptom of HF (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea) has worsened from baseline
- ≥ 2 signs of HF (pulmonary congestion on exam and/or chest X-ray, elevated jugular venous pressure, peripheral edema or rapid weight gain, and/or increased B-type natriuretic peptide (BNP; ≥100 pg/ml)
- change in medical treatment specifically targeting HF (diuretics, vasodilators, and/or neurohormonal modulating agents)
- no other cause of the patient's symptoms and signs is apparent
Who cannot join
- persistent hypotension during hospitalization or excessive risk of hypotension from the study diet as judged by the investigators or systolic BP <110 on discharge
- use of inotropic therapy at hospital discharge,
- severe valvular heart disease as the primary etiology of the patient's HF syndrome
- uncontrolled hypertension defined as the following criteria for the last 24 hours prior to discharge (systolic BP >180 mmHg or diastolic BP >100 mmHg)
- having two or more results of a serum potassium >5.0 mmol/L during hospitalization or history of serum potassium >6.0 mmol/L, and/or at an excessive risk of hyperkalemia as judged by the investigators
- severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73m^2 at discharge)
Show all 11Show fewer
- severe anemia (hemoglobin < 9 gm/dl)
- length of stay <48 hours or >14 days
- co-morbidity with expected survival < 12 months
- active alcohol or substance abuse
- history of persistent noncompliance with treatment recommendations as judged by the investigators
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ann Arbor Veterans Affairs Health System
Ann Arbor, Michigan, 48105
University of Michigan
Ann Arbor, Michigan, 48109
Columbia University
New York, New York, 10032
About this study
Official title: Effects of Home-delivered Low-sodium Meals in Older Adults Following Heart Failure Hospitalization.
Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge.
Read the detailed description
This is a three center, randomized, single-blind, attention controlled trial of 12 weeks total duration designed to determine the safety and efficacy of home-delivered sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD)-compliant meals in older adults (age >= 65 years) following discharge from a hospital admission for acutely decompensated heart failure. 66 subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction (< vs. ≥ 50%).
107 subjects yielded 66 randomized subjects.
Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge. The three study sites will be Columbia University Medical Center, the Ann Arbor Veterans Affairs Health System, and the University of Michigan Health System. Investigators will be blinded to group assignment, food diaries, and urinary electrolyte measurements until the completion of the study
- Conditions
- Heart Failure
- Being tested
- DASH/SRD, Usual care
- Keywords
- Heart Failure, Diet
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH/SRDOther
Also called Mom's Meals
Study food for this investigation will be designed and prepared by PurFoods, LLC (Des Moines, IA) dietitians under the direction of Dr. Sam Beattie, Ph. D., and in consultation with research dietitians at the University of Michigan and Columbia University. Study patients randomized to food delivery will select from an available menu of meal options that adhere to nutritional targets as above. Study food will be pre-packaged for storage with preparation (typically microwave heating) to be completed at home by the subject, and will be delivered every 1 to 2 weeks under the direction of PurFoods.
Usual careOther
Standardized advice to restrict dietary sodium intake to < 2000 mg/day
| Study group | Role | What they receive |
|---|---|---|
| DASH/SRD | Experimental | Patients receive Heart Failure Society of America pamphlet, "How to eat a low sodium diet" at hospital discharge
Study staff will phone patients at weeks 2 and 3 to confirm patients' understanding of dietary instructions
Intervention: pre-prepared, home delivered DASH/SRD-compliant meals for 4 weeks after hospital discharge Receives: Other: DASH/SRD |
| Attention Control | Placebo comparator | Patients receive Heart Failure Society of America pamphlet, "How to eat a low sodium diet" at hospital discharge
Study staff will phone patients at weeks 2 and 3 to confirm patients' understanding of dietary instructions Receives: Other: DASH/SRD; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary scores for health-related QOL in patients with chronic HF
The KCCQ, a self-administered 23-item instrument, assesses physical limitations, symptoms, self-efficacy, social interference, and overall QOL in HF patients. The KCCQ summary score ranges from 0-100, with higher scores indicating better QOL. The KCCQ summary score independently predicts clinical outcomes such as hospitalization and mortality in outpatients with HF, including those recently hospitalized for acute decompensation. It is a reliable and valid measure in HF patients that is more sensitive to change than other measures of QOL, and is especially responsive in patients with multiple comorbidities. A change in KCCQ score of 5 points is clinically significant and correlates with changes in clinical status, physical function, and outcomes.
Measured: from study enrollment to 4 weeks post-discharge
Secondary outcomes (3)
Safety Monitoring
Renal function and electrolytes will be assessed at baseline and 1 week post-discharge during a safety visit, in which vital signs and targeted physical examination for volume status will allow adjustment of diuretics as clinically indicated. The dietary intervention will be stopped in any patient who develops new or worsened renal impairment as defined by estimated glomerular filtration rate decrease of ≥50%, hyperkalemia (K >5.7 mmol/L), syncope, or other serious adverse event deemed by the investigators to be related to study participation (note participants are inherently at high risk for rehospitalization or mortality, ~20-25% over the 4-week intervention period of the study, ~30-35% over the total 12-week term of the study). Patients randomized to food delivery will have study food intake suspended if hospitalized and resumed at discharge if no safety concerns as defined above.
Measured: Baseline and 1 week post discharge
Dietary Endpoints
Dietary endpoints will include DASH/SRD adherence as measured by 3-day food diary and urinary electrolyte measures (24-hour urinary sodium and potassium). Food frequency questionnaire to establish baseline dietary intake will be obtained at baseline and 12 weeks.
Measured: baseline, 4 weeks
Mechanism-related endpoints
Mechanism-related endpoints will include changes from baseline to 4 weeks in clinic and 24-hour blood pressure, noninvasive measures of ventricular function and ventricular-arterial coupling, blood/urine measures of neurohormonal activation, oxidative stress, and systemic inflammation, blood volume measurements (subset n=20), and peripheral blood mononuclear cell (PBMC) RNA profiling (subset n=20)
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completion21 May 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 University of MichiganThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- PurFoods, LLC, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Scott L. Hummel, University of Michigan
- Investigators
- Scott L Hummel, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148679
- Sponsor's protocol ID
- HUM00083272
- Other IDs
- R21AG047939
- Acronym
- GOURMET-HF
- Status last verified
- Jul 2017
- First submitted
- 23 May 2014
- Last updated
- 27 Jul 2017
- Results posted
- No
Publications
Hummel SL, DeFranco AC, Skorcz S, Montoye CK, Koelling TM. Recommendation of low-salt diet and short-term outcomes in heart failure with preserved systolic function. Am J Med. 2009 Nov;122(11):1029-36. doi: 10.1016/j.amjmed.2009.04.025.
PubMed 19854331Hummel SL, Seymour EM, Brook RD, Kolias TJ, Sheth SS, Rosenblum HR, Wells JM, Weder AB. Low-sodium dietary approaches to stop hypertension diet reduces blood pressure, arterial stiffness, and oxidative stress in hypertensive heart failure with preserved ejection fraction. Hypertension. 2012 Nov;60(5):1200-6. doi: 10.1161/HYPERTENSIONAHA.112.202705. Epub 2012 Oct 1.
PubMed 23033371Hummel SL, Seymour EM, Brook RD, Sheth SS, Ghosh E, Zhu S, Weder AB, Kovacs SJ, Kolias TJ. Low-sodium DASH diet improves diastolic function and ventricular-arterial coupling in hypertensive heart failure with preserved ejection fraction. Circ Heart Fail. 2013 Nov;6(6):1165-71. doi: 10.1161/CIRCHEARTFAILURE.113.000481. Epub 2013 Aug 28.
PubMed 23985432Bray GA, Vollmer WM, Sacks FM, Obarzanek E, Svetkey LP, Appel LJ; DASH Collaborative Research Group. A further subgroup analysis of the effects of the DASH diet and three dietary sodium levels on blood pressure: results of the DASH-Sodium Trial. Am J Cardiol. 2004 Jul 15;94(2):222-7. doi: 10.1016/j.amjcard.2004.03.070.
PubMed 15246908Troyer JL, Racine EF, Ngugi GW, McAuley WJ. The effect of home-delivered Dietary Approach to Stop Hypertension (DASH) meals on the diets of older adults with cardiovascular disease. Am J Clin Nutr. 2010 May;91(5):1204-12. doi: 10.3945/ajcn.2009.28780. Epub 2010 Mar 3.
PubMed 20200258Racine EF, Lyerly J, Troyer JL, Warren-Findlow J, McAuley WJ. The influence of home-delivered dietary approaches to stop hypertension meals on body mass index, energy intake, and percent of energy needs consumed among older adults with hypertension and/or hyperlipidemia. J Acad Nutr Diet. 2012 Nov;112(11):1755-62. doi: 10.1016/j.jand.2012.06.358.
PubMed 23102175Wessler JD, Maurer MS, Hummel SL. Evaluating the safety and efficacy of sodium-restricted/Dietary Approaches to Stop Hypertension diet after acute decompensated heart failure hospitalization: design and rationale for the Geriatric OUt of hospital Randomized MEal Trial in Heart Failure (GOURMET-HF). Am Heart J. 2015 Mar;169(3):342-348.e4. doi: 10.1016/j.ahj.2014.11.021. Epub 2015 Jan 7.
PubMed 25728723Bilgen F, Chen P, Poggi A, Wells J, Trumble E, Helmke S, Teruya S, Catalan T, Rosenblum HR, Cornellier ML, Karmally W, Maurer MS, Hummel SL. Insufficient Calorie Intake Worsens Post-Discharge Quality of Life and Increases Readmission Burden in Heart Failure. JACC Heart Fail. 2020 Sep;8(9):756-764. doi: 10.1016/j.jchf.2020.04.004. Epub 2020 Jul 8.
PubMed 32653445Hummel SL, Karmally W, Gillespie BW, Helmke S, Teruya S, Wells J, Trumble E, Jimenez O, Marolt C, Wessler JD, Cornellier ML, Maurer MS. Home-Delivered Meals Postdischarge From Heart Failure Hospitalization. Circ Heart Fail. 2018 Aug;11(8):e004886. doi: 10.1161/CIRCHEARTFAILURE.117.004886.
PubMed 30354562
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-delivered Low-sodium Meals in Older Adults Following Heart Failure Hospitalization.
- ClinicalTrials.gov ID
- NCT02148679
- Acronym / sponsor ID
- GOURMET-HF / HUM00083272
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- PurFoods, LLC, National Institute on Aging (NIA)
- Study start
- May 2014 (actual)
- Primary completion
- 21 May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 28 May 2014 (estimated)
- 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.
Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge.
Detailed description
This is a three center, randomized, single-blind, attention controlled trial of 12 weeks total duration designed to determine the safety and efficacy of home-delivered sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD)-compliant meals in older adults (age >= 65 years) following discharge from a hospital admission for acutely decompensated heart failure. 66 subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction (< vs. ≥ 50%).
107 subjects yielded 66 randomized subjects.
Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or attention control for 4 weeks after hospital discharge. The three study sites will be Columbia University Medical Center, the Ann Arbor Veterans Affairs Health System, and the University of Michigan Health System. Investigators will be blinded to group assignment, food diaries, and urinary electrolyte measurements until the completion of the study
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH/SRD | Experimental | Other: DASH/SRDPatients receive Heart Failure Society of America pamphlet, "How to eat a low sodium diet" at hospital discharge Study staff will phone patients at weeks 2 and 3 to confirm patients' understanding of dietary instructions Intervention: pre-prepared, home delivered DASH/SRD-compliant meals for 4 weeks after hospital discharge |
| Attention Control | Placebo comparator | Other: DASH/SRD, Other: Usual carePatients receive Heart Failure Society of America pamphlet, "How to eat a low sodium diet" at hospital discharge Study staff will phone patients at weeks 2 and 3 to confirm patients' understanding of dietary instructions |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 66 male and female patients aged ≥ 55 years with history of systemic hypertension and acutely decompensated heart failure (ADHF; primary diagnosis for admission or secondary diagnosis after hospitalization for another reason). ADHF will be confirmed by the study physician and defined as a combination of symptoms, signs, and HF-specific medical treatments. Specifically, ADHF will require that all four of the following conditions are met:
- ≥1 symptom of HF (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea) has worsened from baseline
- ≥ 2 signs of HF (pulmonary congestion on exam and/or chest X-ray, elevated jugular venous pressure, peripheral edema or rapid weight gain, and/or increased B-type natriuretic peptide (BNP; ≥100 pg/ml)
- change in medical treatment specifically targeting HF (diuretics, vasodilators, and/or neurohormonal modulating agents)
- no other cause of the patient's symptoms and signs is apparent
Key exclusion criteria (11 listed)
- persistent hypotension during hospitalization or excessive risk of hypotension from the study diet as judged by the investigators or systolic BP <110 on discharge
- use of inotropic therapy at hospital discharge,
- severe valvular heart disease as the primary etiology of the patient's HF syndrome
- uncontrolled hypertension defined as the following criteria for the last 24 hours prior to discharge (systolic BP >180 mmHg or diastolic BP >100 mmHg)
- having two or more results of a serum potassium >5.0 mmol/L during hospitalization or history of serum potassium >6.0 mmol/L, and/or at an excessive risk of hyperkalemia as judged by the investigators
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 |
|---|---|---|
| DASH/SRDAlso: Mom's MealsStudy food for this investigation will be designed and prepared by PurFoods, LLC (Des Moines, IA) dietitians under the direction of Dr. Sam Beattie, Ph. D., and in consultation with research dietitians at the University of Michigan and Columbia University. Study patients randomized to food delivery will select from an available menu of meal options that adhere to nutritional targets as above. Study food will be pre-packaged for storage with preparation (typically microwave heating) to be completed at home by the subject, and will be delivered every 1 to 2 weeks under the direction of PurFoods. | Other | Attention Control, DASH/SRD |
| Usual careStandardized advice to restrict dietary sodium intake to < 2000 mg/day | Other | Attention Control |
Primary outcome
change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary scores for health-related QOL in patients with chronic HF
Time frame: from study enrollment to 4 weeks post-discharge
The KCCQ, a self-administered 23-item instrument, assesses physical limitations, symptoms, self-efficacy, social interference, and overall QOL in HF patients. The KCCQ summary score ranges from 0-100, with higher scores indicating better QOL. The KCCQ summary score independently predicts clinical outcomes such as hospitalization and mortality in outpatients with HF, including those recently hospitalized for acute decompensation. It is a reliable and valid measure in HF patients that is more sensitive to change than other measures of QOL, and is especially responsive in patients with multiple comorbidities. A change in KCCQ score of 5 points is clinically significant and correlates with changes in clinical status, physical function, and outcomes.
3 secondary outcomes
Safety Monitoring
Time frame: Baseline and 1 week post discharge
Dietary Endpoints
Time frame: baseline, 4 weeks
Mechanism-related endpoints
Time frame: Baseline to 4 weeks
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 27 Jul 2017.
- Background: PubMed 19854331Hummel SL, DeFranco AC, Skorcz S, Montoye CK, Koelling TM. Recommendation of low-salt diet and short-term outcomes in heart failure with preserved systolic function. Am J Med. 2009 Nov;122(11):1029-36. doi: 10.1016/j.amjmed.2009.04.025.
- Background: PubMed 23033371Hummel SL, Seymour EM, Brook RD, Kolias TJ, Sheth SS, Rosenblum HR, Wells JM, Weder AB. Low-sodium dietary approaches to stop hypertension diet reduces blood pressure, arterial stiffness, and oxidative stress in hypertensive heart failure with preserved ejection fraction. Hypertension. 2012 Nov;60(5):1200-6. doi: 10.1161/HYPERTENSIONAHA.112.202705. Epub 2012 Oct 1.
- Background: PubMed 23985432Hummel SL, Seymour EM, Brook RD, Sheth SS, Ghosh E, Zhu S, Weder AB, Kovacs SJ, Kolias TJ. Low-sodium DASH diet improves diastolic function and ventricular-arterial coupling in hypertensive heart failure with preserved ejection fraction. Circ Heart Fail. 2013 Nov;6(6):1165-71. doi: 10.1161/CIRCHEARTFAILURE.113.000481. Epub 2013 Aug 28.
- Background: PubMed 15246908Bray GA, Vollmer WM, Sacks FM, Obarzanek E, Svetkey LP, Appel LJ; DASH Collaborative Research Group. A further subgroup analysis of the effects of the DASH diet and three dietary sodium levels on blood pressure: results of the DASH-Sodium Trial. Am J Cardiol. 2004 Jul 15;94(2):222-7. doi: 10.1016/j.amjcard.2004.03.070.
- Background: PubMed 20200258Troyer JL, Racine EF, Ngugi GW, McAuley WJ. The effect of home-delivered Dietary Approach to Stop Hypertension (DASH) meals on the diets of older adults with cardiovascular disease. Am J Clin Nutr. 2010 May;91(5):1204-12. doi: 10.3945/ajcn.2009.28780. Epub 2010 Mar 3.
- Background: PubMed 23102175Racine EF, Lyerly J, Troyer JL, Warren-Findlow J, McAuley WJ. The influence of home-delivered dietary approaches to stop hypertension meals on body mass index, energy intake, and percent of energy needs consumed among older adults with hypertension and/or hyperlipidemia. J Acad Nutr Diet. 2012 Nov;112(11):1755-62. doi: 10.1016/j.jand.2012.06.358.
- Background: PubMed 25728723Wessler JD, Maurer MS, Hummel SL. Evaluating the safety and efficacy of sodium-restricted/Dietary Approaches to Stop Hypertension diet after acute decompensated heart failure hospitalization: design and rationale for the Geriatric OUt of hospital Randomized MEal Trial in Heart Failure (GOURMET-HF). Am Heart J. 2015 Mar;169(3):342-348.e4. doi: 10.1016/j.ahj.2014.11.021. Epub 2015 Jan 7.
- Derived from this study: PubMed 32653445Bilgen F, Chen P, Poggi A, Wells J, Trumble E, Helmke S, Teruya S, Catalan T, Rosenblum HR, Cornellier ML, Karmally W, Maurer MS, Hummel SL. Insufficient Calorie Intake Worsens Post-Discharge Quality of Life and Increases Readmission Burden in Heart Failure. JACC Heart Fail. 2020 Sep;8(9):756-764. doi: 10.1016/j.jchf.2020.04.004. Epub 2020 Jul 8.
- Derived from this study: PubMed 30354562Hummel SL, Karmally W, Gillespie BW, Helmke S, Teruya S, Wells J, Trumble E, Jimenez O, Marolt C, Wessler JD, Cornellier ML, Maurer MS. Home-Delivered Meals Postdischarge From Heart Failure Hospitalization. Circ Heart Fail. 2018 Aug;11(8):e004886. doi: 10.1161/CIRCHEARTFAILURE.117.004886.
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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.
Scott L Hummel, MD, MS principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH/SRD in people with Heart Failure, run by University of Michigan at 3 sites 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 5 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary scores for health-related QOL in patients with chronic HF (time frame: from study enrollment to 4 weeks post-discharge). 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 NCT02148679, which also lists 9 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 27 Jul 2017.