Heart FailureCADYSHNCT06532825
Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure
An observational study of Heart Failure, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The main hypothesis is that autonomic dysfunction cannot improve among patients reaching end-stage heart failure. To evaluate this, patients admitted with acute decompensated heart failure in Bispebjerg hospital, and history one or more admissions with the same condition within the prior year, will undergo repeated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- heart monitoring
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2024to 31 Dec 2025
- Phase
- Observational
- 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
Study population: Patients admitted to the hospital with acute decompensated heart failure, regardless of measured left ventricle ejection fraction. Patients will be grouped according to rhythm: sinus rhythm and atrial fibrillation.
Who may be able to join
- 18-years age or older
- admitted with acute decompensated heart failure for less than 48 h
Who cannot join
- pacemaker
- not signed informed consent
- other heart rhythm than sinus rhythm or atrial fibrillation
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Cardiology department Y, Bispebjerg-Frederiksberg Hospital
Frederiksberg, 2000
Helena Dominguez, MD, PhD, +4538163916 ext. 6068, mdom0002@regionh.dk
Christoffer V Madsen, MD, +4520661178, cmad0140@regionh.dk
About this study
The main hypothesis is that autonomic dysfunction cannot improve among patients reaching end-stage heart failure. To evaluate this, patients admitted with acute decompensated heart failure in Bispebjerg hospital, and history one or more admissions with the same condition within the prior year, will undergo repeated brief heart monitoring (10 min). Baseline recordings (at admission) will be compared with equivalent measurements before discharge to explore whether heart rate variability increases. Patients will be followed for six months after discharge from the hospital.
Read the detailed description
If the patient accepts to participate and signed the project informed consent, their clinical record will be followed until the last patient included has been followed for six months.
- Conditions
- Heart Failure
- Being tested
- heart monitoring
- Keywords
- heart failure, decompensated
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart monitoringDiagnostic test
Also called heart rate variability
individual comparison of heart rate variability at admission with a repeated measurement before discharge
What is being measured
The primary outcome is the main question the study is designed to answer.
number of rehospitalizations
number of emergency rehospitalizations, classified according to:
- new decompensation of heart failure
- side effects / complications to therapy for heart failure
- other
Measured: up to six months after discharge from index admission
Secondary outcomes (1)
Heart rate Variability change from admission to discharge
Measurement of heart-rate oscillations over a short term (30 min) of continuous three-lead electrocardiogram recording divided into two time domains:
Domain 10min: relaxed, supine position for 10 min Domain 30 min: comprising the first 10 min-domain in addition to stand-up and walking for 5 min, followed by sitting relaxed until completing 30 min recording in total
Measured: repeated measurement at baseline (within 48h from time of index admission) and before discharge (estimated one week on average from index admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Aug 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena DOMINGUEZ, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532825
- Sponsor's protocol ID
- H-24002374
- Acronym
- CADYSH
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT06532825
- Acronym / sponsor ID
- CADYSH / H-24002374
- Conditions
- Heart Failure
- Keywords
- heart failure, decompensated
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 2024 (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.
The main hypothesis is that autonomic dysfunction cannot improve among patients reaching end-stage heart failure. To evaluate this, patients admitted with acute decompensated heart failure in Bispebjerg hospital, and history one or more admissions with the same condition within the prior year, will undergo repeated brief heart monitoring (10 min). Baseline recordings (at admission) will be compared with equivalent measurements before discharge to explore whether heart rate variability increases. Patients will be followed for six months after discharge from the hospital.
Detailed description
If the patient accepts to participate and signed the project informed consent, their clinical record will be followed until the last patient included has been followed for six months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital with acute decompensated heart failure, regardless of measured left ventricle ejection fraction. Patients will be grouped according to rhythm: sinus rhythm and atrial fibrillation.
Key inclusion criteria (2 listed)
- 18-years age or older
- admitted with acute decompensated heart failure for less than 48 h
Key exclusion criteria (3 listed)
- pacemaker
- not signed informed consent
- other heart rhythm than sinus rhythm or atrial fibrillation
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 |
|---|---|---|
| heart monitoringAlso: heart rate variabilityindividual comparison of heart rate variability at admission with a repeated measurement before discharge | Diagnostic test | – |
Primary outcome
number of rehospitalizations
Time frame: up to six months after discharge from index admission
number of emergency rehospitalizations, classified according to: 1. new decompensation of heart failure 2. side effects / complications to therapy for heart failure 3. other
1 secondary outcome
Heart rate Variability change from admission to discharge
Time frame: repeated measurement at baseline (within 48h from time of index admission) and before discharge (estimated one week on average from index admission)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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 2 inclusion and 3 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 25 Feb 2025. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helena Dominguez (22989343, mdom0002@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of rehospitalizations (time frame: up to six months after discharge from index admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025.