Heart FailureDYNAMICNCT06131008
Diastology-Guided Management of Decompensated Heart Failure
A study testing Diastology and Diastology-Guided Diuresis in people with Heart Failure and Diastolic Dysfunction, run by McMaster University.
Trial summary
More than 30% of people hospitalized with decompensated heart failure return to the hospital within 90 days. Emerging evidence suggests that hemodynamic monitoring with guided management may enhance prognosis and management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic Dysfunction
- What is being tested?
- Diastology and Diastology-Guided Diuresis
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2023to 31 Jul 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
- Age ≥18 years at the time of enrolment
- Decompensated heart failure with reduced ejection fraction (≤40%)
- Sinus rhythm without conduction abnormalities (second-degree Mobitz II, third-degree, permanent pacemaker)
- Written informed consent from either the patient or a substitute decision maker
Who cannot join
- Mitral annular calcification (at least moderate or severe)
- Moderate or severe aortic or mitral valvular heart disease, or history of prosthetic mitral valve
- Atrial fibrillation or flutter
- History of non-diagnostic echocardiogram
- Hemodialysis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: DiastologY-Guided MaNAgement of DecoMpensated Heart Failure: A Pilot RandomIzed, Controlled Trial
More than 30% of people hospitalized with decompensated heart failure return to the hospital within 90 days. Emerging evidence suggests that hemodynamic monitoring with guided management may enhance prognosis and management. Hemodynamic monitoring with echocardiography using diastology and an evidence-informed therapeutic protocol have the potential to achieve this aim in a minimally invasive manner.
- Conditions
- Heart Failure, Diastolic Dysfunction
- Being tested
- Diastology, Diastology-Guided Diuresis, Usual Care
- Keywords
- diastology, echocardiography, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiastologyDiagnostic test
We will follow American Society of Echocardiography criteria to determine the degree of diastolic dysfunction after performing each focused echocardiogram.
Diastology-Guided DiuresisBehavioural
If the daily urine output or weight loss are less than study-specified targets, then the research team will recommend changes to the diuretic regimen based on the degree of diastolic dysfunction.
Usual CareBehavioural
Clinicians will rely on usual care metrics and parameters to guide diuresis.
| Study group | Role | What they receive |
|---|---|---|
| Diastology-Guided Management | Experimental | Participants in this arm will undergo a focused echocardiogram every 24 hours. The degree of diastolic dysfunction will be reported to the healthcare team. If the degree of diastolic dysfunction is greater than or equal to grade 2, the research team will recommend escalating the diuretic regimen if either (1) urine output is less than 4,000 mL over 24 hours or (2) weight loss is less than 2 kg over 24 hours. If the degree of diastolic dysfunction is grade 1, the research team will recommend transitioning to or discontinuing oral diuresis. Receives: Diagnostic Test: Diastology; Behavioral: Diastology-Guided Diuresis |
| Usual Care | Active comparator | Participants in this arm will also undergo a focused echocardiogram every 24 hours. However, the results of these echocardiograms will not be available for clinical decision-making. Instead, participants will receive usual care by the healthcare team without daily hemodynamic parameters from a study echocardiogram. Receives: Diagnostic Test: Diastology; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
This is calculated as the number of participants enrolled in the study per month.
Measured: 12 months (anticipated study duration)
Secondary outcomes (4)
Compliance with Echocardiograms
This is calculated as the number of echocardiograms completed divided by the number scheduled as per the study protocol.
Measured: 12 months (anticipated study duration)
Interpretability of Echocardiograms
This is calculated as the number of studies without indeterminate diastolic dysfunction divided by the total number of studies performed.
Measured: 12 months (anticipated study duration)
Adherence to Protocol Recommendations
This is calculated as the number of treatment decisions in the intervention arm that is aligned (increase, maintain, or decrease) with the therapeutic recommendations of the trial based on the severity of diastolic dysfunction divided by the number of studies completed.
Measured: 12 months (anticipated study duration)
Follow-Up at 30 and 90 Days
This is calculated as the number of participants that complete a follow-up visit with a study team member at 30 and 90 days, respectively.
Measured: 12 months (anticipated study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start6 Nov 2023 (estimated)
- Primary completion8 Apr 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 McMaster 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Belley-Cote, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131008
- Sponsor's protocol ID
- 15276
- Acronym
- DYNAMIC
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan MS, Sreenivasan J, Lateef N, Abougergi MS, Greene SJ, Ahmad T, Anker SD, Fonarow GC, Butler J. Trends in 30- and 90-Day Readmission Rates for Heart Failure. Circ Heart Fail. 2021 Apr;14(4):e008335. doi: 10.1161/CIRCHEARTFAILURE.121.008335. Epub 2021 Apr 19.
PubMed 33866827Van Spall HGC, Lee SF, Xie F, Oz UE, Perez R, Mitoff PR, Maingi M, Tjandrawidjaja MC, Heffernan M, Zia MI, Porepa L, Panju M, Thabane L, Graham ID, Haynes RB, Haughton D, Simek KD, Ko DT, Connolly SJ. Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: The PACT-HF Randomized Clinical Trial. JAMA. 2019 Feb 26;321(8):753-761. doi: 10.1001/jama.2019.0710.
PubMed 30806695Felker GM, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL Jr, Mark DB, Pina IL, Passmore G, Whellan DJ, Yang H, Cooper LS, Leifer ES, Desvigne-Nickens P, O'Connor CM. Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2017 Aug 22;318(8):713-720. doi: 10.1001/jama.2017.10565.
PubMed 28829876Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3.
PubMed 21315441Nagueh 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 27037982Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB; CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. 2016 Jan 30;387(10017):453-61. doi: 10.1016/S0140-6736(15)00723-0. Epub 2015 Nov 9.
PubMed 26560249
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiastologY-Guided MaNAgement of DecoMpensated Heart Failure: A Pilot RandomIzed, Controlled Trial
- ClinicalTrials.gov ID
- NCT06131008
- Acronym / sponsor ID
- DYNAMIC / 15276
- Conditions
- Heart Failure, Diastolic Dysfunction
- Keywords
- diastology, echocardiography, heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 6 Nov 2023 (estimated)
- Primary completion
- 8 Apr 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 14 Nov 2023 (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.
More than 30% of people hospitalized with decompensated heart failure return to the hospital within 90 days. Emerging evidence suggests that hemodynamic monitoring with guided management may enhance prognosis and management. Hemodynamic monitoring with echocardiography using diastology and an evidence-informed therapeutic protocol have the potential to achieve this aim in a minimally invasive manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diastology-Guided Management | Experimental | Diagnostic Test: Diastology, Behavioral: Diastology-Guided DiuresisParticipants in this arm will undergo a focused echocardiogram every 24 hours. The degree of diastolic dysfunction will be reported to the healthcare team. If the degree of diastolic dysfunction is greater than or equal to grade 2, the research team will recommend escalating the diuretic regimen if either (1) urine output is less than 4,000 mL over 24 hours or (2) weight loss is less than 2 kg over 24 hours. If the degree of diastolic dysfunction is grade 1, the research team will recommend transitioning to or discontinuing oral diuresis. |
| Usual Care | Active comparator | Diagnostic Test: Diastology, Behavioral: Usual CareParticipants in this arm will also undergo a focused echocardiogram every 24 hours. However, the results of these echocardiograms will not be available for clinical decision-making. Instead, participants will receive usual care by the healthcare team without daily hemodynamic parameters from a study echocardiogram. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years at the time of enrolment
- Decompensated heart failure with reduced ejection fraction (≤40%)
- Sinus rhythm without conduction abnormalities (second-degree Mobitz II, third-degree, permanent pacemaker)
- Written informed consent from either the patient or a substitute decision maker
Key exclusion criteria (5 listed)
- Mitral annular calcification (at least moderate or severe)
- Moderate or severe aortic or mitral valvular heart disease, or history of prosthetic mitral valve
- Atrial fibrillation or flutter
- History of non-diagnostic echocardiogram
- Hemodialysis
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 |
|---|---|---|
| DiastologyWe will follow American Society of Echocardiography criteria to determine the degree of diastolic dysfunction after performing each focused echocardiogram. | Diagnostic test | Diastology-Guided Management, Usual Care |
| Diastology-Guided DiuresisIf the daily urine output or weight loss are less than study-specified targets, then the research team will recommend changes to the diuretic regimen based on the degree of diastolic dysfunction. | Behavioural | Diastology-Guided Management |
| Usual CareClinicians will rely on usual care metrics and parameters to guide diuresis. | Behavioural | Usual Care |
Primary outcome
Recruitment Rate
Time frame: 12 months (anticipated study duration)
This is calculated as the number of participants enrolled in the study per month.
4 secondary outcomes
Compliance with Echocardiograms
Time frame: 12 months (anticipated study duration)
Interpretability of Echocardiograms
Time frame: 12 months (anticipated study duration)
Adherence to Protocol Recommendations
Time frame: 12 months (anticipated study duration)
Follow-Up at 30 and 90 Days
Time frame: 12 months (anticipated study duration)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 33866827Khan MS, Sreenivasan J, Lateef N, Abougergi MS, Greene SJ, Ahmad T, Anker SD, Fonarow GC, Butler J. Trends in 30- and 90-Day Readmission Rates for Heart Failure. Circ Heart Fail. 2021 Apr;14(4):e008335. doi: 10.1161/CIRCHEARTFAILURE.121.008335. Epub 2021 Apr 19.
- Background: PubMed 30806695Van Spall HGC, Lee SF, Xie F, Oz UE, Perez R, Mitoff PR, Maingi M, Tjandrawidjaja MC, Heffernan M, Zia MI, Porepa L, Panju M, Thabane L, Graham ID, Haynes RB, Haughton D, Simek KD, Ko DT, Connolly SJ. Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: The PACT-HF Randomized Clinical Trial. JAMA. 2019 Feb 26;321(8):753-761. doi: 10.1001/jama.2019.0710.
- Background: PubMed 28829876Felker GM, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL Jr, Mark DB, Pina IL, Passmore G, Whellan DJ, Yang H, Cooper LS, Leifer ES, Desvigne-Nickens P, O'Connor CM. Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2017 Aug 22;318(8):713-720. doi: 10.1001/jama.2017.10565.
- Background: PubMed 21315441Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3.
- 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.
- Background: PubMed 26560249Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB; CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. 2016 Jan 30;387(10017):453-61. doi: 10.1016/S0140-6736(15)00723-0. Epub 2015 Nov 9.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Diastology and Diastology-Guided Diuresis in people with Heart Failure and Diastolic Dysfunction, run by McMaster University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin J Um, MD (905-521-2100 ext. 40741, kevin.um@dataparty.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 12 months (anticipated study duration)). 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 NCT06131008, which also lists 6 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 14 Nov 2023.