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

NCT07647848 | Not Yet Recruiting

• 3 other identifiers: TAILOR-HF101112022No 10088702
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Heart Failure; Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

• time to death or a worsening heart failure event

  time to death or a worsening heart failure event

  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

  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

  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

  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

  6 months

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

  6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Additional blood samples are collected. These samples will be used for the assessment of biomarkers and proteomic analysis at the end of the trial.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06