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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Heart Failure; Acute Decompensated Heart Failure

• Study Type: Observational
• Enrollment (Estimated): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

1. Provide written and dated informed consent for participation prior to trial admission,
2. Age ≥18 years, female or male
3. A clinical diagnosis of new onset or worsening of heart failure with a left-ventricular ejection fraction of <50%
4. On treatment with oral or i.v. furosemide ≥40 mg/day or equivalent (bumetanide 1mg, torasemide 10mg)
5. Receiving <50% of the target doses of at least one of the guidelines recommended pharmacological therapies (clear intolerance not considered)
6. Anticipated or planned uptitration

Exclusion Criteria:

1. Scheduled or on renal replacement therapy,
2. Clearly documented intolerance to two or more of the following groups of drugs: BB, ARNI, SGLT2i or MRAs.
3. 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.
4. The presence of a mechanical assist device,
5. Scheduled for mechanical assist device or heart transplant,
6. Current angina pectoris ≥class III,
7. Requiring valvular surgery or revascularization in the upcoming 3 months or Coronary Artery Bypass Grafting (CABG) within the past 3 months,
8. Anticipated need for surgery or any other cardiovascular intervention, except implantable cardioverter defibrillator and/or cardiac resynchronization therapy, within 4 weeks,
9. Other non-cardiac conditions with limited life expectancy (≤ duration of the trial/ 1 year),
10. Participation in another clinical trial apart from non-interventional studies.
11. 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.
12. Women who are pregnant, breastfeeding or those considering becoming pregnant
13. Subjects unable to provide informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to cardiovascular (CV) mortality	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	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	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	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	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.	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TAILOR-HF; No 10088702 (Other Grant/Funding Number: UK Research and Innovation (UKRI)); 101112022 (Other Grant/Funding Number: Innovative Health Initiative Joint Undertaking (IHI JU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No