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Not yet recruiting NCT07647848

Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure

— Observational Chronic Heart Failure Acute Decompensated Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Heart Failure, Acute Decompensated Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure (TAILOR-HF)

Overview

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.

Primary outcome measures

  • 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 outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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,
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07647848 · TAILOR-HF · 101112022 · No 10088702

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗