Chronic Heart FailureTAILOR-HFNCT07647848
Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure
An observational study of Chronic Heart Failure and Acute Decompensated Heart Failure, run by Maastricht University Medical Center.
Trial summary
The goal of TAILOR-HF is to integrate clinical data, laboratory parameters, treatment patterns, and circulating biomarkers to identify factors that predict individual response to pharmacological treatment in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Acute Decompensated Heart Failure
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with either de novo HF or (acute) decompensated HF who are not yet on optimal doses of guideline-recommended therapies and in whom up-titration is anticipated. Patients will be enrolled either at the outpatient clinic of participating sites or prior to dis-charge of patients who are hospitalized for worsening HF
Who may be able to join
- Provide written and dated informed consent for participation prior to trial admission,
- Age ≥18 years, female or male
- A clinical diagnosis of new onset or worsening of heart failure with a left-ventricular ejection fraction of <50%
- On treatment with oral or i.v. furosemide ≥40 mg/day or equivalent (bumetanide 1mg, torasemide 10mg)
- Receiving <50% of the target doses of at least one of the guidelines recommended pharmacological therapies (clear intolerance not considered)
- Anticipated or planned uptitration
Who cannot join
- Scheduled or on renal replacement therapy,
- Clearly documented intolerance to two or more of the following groups of drugs: BB, ARNI, SGLT2i or MRAs.
- Diagnosis of peripartum cardiomyopathy, chemotherapy induced cardiomyopathy, current viral myocarditis, right heart failure in absence of left-sided structural disease, pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloidosis.
- The presence of a mechanical assist device,
- Scheduled for mechanical assist device or heart transplant,
- Current angina pectoris ≥class III,
Show all 13Show fewer
- Requiring valvular surgery or revascularization in the upcoming 3 months or Coronary Artery Bypass Grafting (CABG) within the past 3 months,
- Anticipated need for surgery or any other cardiovascular intervention, except implantable cardioverter defibrillator and/or cardiac resynchronization therapy, within 4 weeks,
- Other non-cardiac conditions with limited life expectancy (≤ duration of the trial/ 1 year),
- Participation in another clinical trial apart from non-interventional studies.
- Patients with an unscheduled hospital visit or admission for reasons that are not primarily related to worsening of heart failure. Therefore, patients with concomitant pulmonary disease, even if severe, valvular disease, acute coronary syndrome or stroke, may be included when the primary diagnosis for admission to hospital or outpatient clinic visit has been heart failure, rather than the concomitant condition.
- Women who are pregnant, breastfeeding or those considering becoming pregnant
- Subjects unable to provide informed consent.
About this study
Official title: Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure (TAILOR-HF)
The goal of TAILOR-HF is to integrate clinical data, laboratory parameters, treatment patterns, and circulating biomarkers to identify factors that predict individual response to pharmacological treatment in patients with heart failure.
TAILOR-HF is an observational study with protocol-mandated assessments scheduled at baseline and at 1, 3, and 6 months after enrolment. Additional follow-up data will be collected through telephone visits every 6 months until the last participant has completed the protocol-mandated 6-month visit.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The cohort | Patients with either de novo HF or (acute) decompensated HF who are not yet on optimal doses of guideline-recommended therapies and in whom up-titration is anticipated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to death or a worsening heart failure event
time to death or a worsening heart failure event
Measured: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Secondary outcomes (5)
Time to cardiovascular (CV) mortality
Time to cardiovascular (CV) mortality
Measured: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Time to first (re)-hospitalization due to heart failure
Time to first (re)-hospitalization due to heart failure
Measured: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Time to all-cause hospitalization
Time to all-cause hospitalization
Measured: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Change in clinical congestion score(10) between baseline and 6 months
change in score in 7-item Clinical Congestion Index, higher meaning more signs, based on following criteria: Orthopnea, NYHA ≥III, paroxysmal nocturnal dyspnea, hepatomegaly, peripheral pitting edema, jugular venous distension, rales
Measured: 6 months
Change in QoL according to the KCCQ-CSS between baseline and 6 months
The change in health status from baseline to 6 months will be assessed using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS). Scores range from 0 to 100, with higher scores indicating better health status, including fewer symptoms and fewer physical limitations.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 600 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMCG, University Hospital (Groningen, The Netherlands), Leiden University Medical Center, Erasmus Medical Center, Uniklinik RTWH Aachen, Charite University, Berlin, Germany, Ospedale San Donato, Fidenza Hospital, Desio Hospital, Gorizia Hospital, UZ Antwerpen, Medizinischen Universität Wien, University College Dublin, University of Ulster, University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647848
- Sponsor's protocol ID
- TAILOR-HF
- Other IDs
- 101112022, No 10088702
- Acronym
- TAILOR-HF
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure (TAILOR-HF)
- ClinicalTrials.gov ID
- NCT07647848
- Acronym / sponsor ID
- TAILOR-HF / TAILOR-HF
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- UMCG, University Hospital (Groningen, The Netherlands), Leiden University Medical Center, Erasmus Medical Center, Uniklinik RTWH Aachen, Charite University, Berlin, Germany, Ospedale San Donato, Fidenza Hospital, Desio Hospital, Gorizia Hospital, UZ Antwerpen, Medizinischen Universität Wien, University College Dublin, University of Ulster, University of Glasgow
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 15 Jun 2026 (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 goal of TAILOR-HF is to integrate clinical data, laboratory parameters, treatment patterns, and circulating biomarkers to identify factors that predict individual response to pharmacological treatment in patients with heart failure.
TAILOR-HF is an observational study with protocol-mandated assessments scheduled at baseline and at 1, 3, and 6 months after enrolment. Additional follow-up data will be collected through telephone visits every 6 months until the last participant has completed the protocol-mandated 6-month visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The cohort | – | –Patients with either de novo HF or (acute) decompensated HF who are not yet on optimal doses of guideline-recommended therapies and in whom up-titration is anticipated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with either de novo HF or (acute) decompensated HF who are not yet on optimal doses of guideline-recommended therapies and in whom up-titration is anticipated. Patients will be enrolled either at the outpatient clinic of participating sites or prior to dis-charge of patients who are hospitalized for worsening HF
Key inclusion criteria (6 listed)
- Provide written and dated informed consent for participation prior to trial admission,
- Age ≥18 years, female or male
- A clinical diagnosis of new onset or worsening of heart failure with a left-ventricular ejection fraction of <50%
- On treatment with oral or i.v. furosemide ≥40 mg/day or equivalent (bumetanide 1mg, torasemide 10mg)
- Receiving <50% of the target doses of at least one of the guidelines recommended pharmacological therapies (clear intolerance not considered)
Key exclusion criteria (13 listed)
- Scheduled or on renal replacement therapy,
- Clearly documented intolerance to two or more of the following groups of drugs: BB, ARNI, SGLT2i or MRAs.
- Diagnosis of peripartum cardiomyopathy, chemotherapy induced cardiomyopathy, current viral myocarditis, right heart failure in absence of left-sided structural disease, pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloidosis.
- The presence of a mechanical assist device,
- Scheduled for mechanical assist device or heart transplant,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time to death or a worsening heart failure event
Time frame: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
time to death or a worsening heart failure event
5 secondary outcomes
Time to cardiovascular (CV) mortality
Time frame: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Time to first (re)-hospitalization due to heart failure
Time frame: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Time to all-cause hospitalization
Time frame: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Change in clinical congestion score(10) between baseline and 6 months
Time frame: 6 months
Change in QoL according to the KCCQ-CSS between baseline and 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Heart Failure
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
RecruitingPhase 3
Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
Heart Failure
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure and Acute Decompensated Heart Failure, run by Maastricht University Medical Center.
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 13 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: opening soon, as of the sponsor's last update on 15 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
time to death or a worsening heart failure event (time frame: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.). 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 15 Jun 2026.