Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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,
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 1 trial groupGroup A: The cohort
Trial outcomes
Primary outcomes
1
time to death or a worsening heart failure event
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.Secondary outcomes
1
Time to cardiovascular (CV) mortality
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.2
Time to first (re)-hospitalization due to heart failure
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.3
Time to all-cause hospitalization
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.4
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
Time frame
6 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Maastricht University Medical Center
Lead sponsor
UMCG, University Hospital (Groningen, The Netherlands)
Collaborator
Leiden University Medical Center
Collaborator
Erasmus Medical Center
Collaborator
Uniklinik RTWH Aachen
Collaborator
Charite University, Berlin, Germany
Collaborator
Ospedale San Donato
Collaborator
Fidenza Hospital
Collaborator
Desio Hospital
Collaborator
Gorizia Hospital
Collaborator
UZ Antwerpen
Collaborator
Medizinischen Universität Wien
Collaborator
University College Dublin
Collaborator
University of Ulster
Collaborator
University of Glasgow
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: