Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07647848

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 cardiovascular (CV) mortality

  2. 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 first (re)-hospitalization due to heart failure

  3. 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.

    Time to all-cause hospitalization

  4. Change in clinical congestion score(10) between baseline and 6 months

    Time frame: 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

  5. Change in QoL according to the KCCQ-CSS between baseline and 6 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Charite University, Berlin, Germany
  • Desio Hospital
  • Erasmus Medical Center
  • Fidenza Hospital
  • Gorizia Hospital
  • Leiden University Medical Center
  • Medizinischen Universität Wien
  • Ospedale San Donato
  • UMCG, University Hospital (Groningen, The Netherlands)
  • UZ Antwerpen
  • Uniklinik RTWH Aachen
  • University College Dublin
  • University of Glasgow
  • University of Ulster

Registry information

Official study title

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

Acronym: TAILOR-HF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.