Acute Decompensated Heart Failure, Chronic Heart Failure
Conditions
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.
Interventions
None listed
Sponsors
Maastricht University Medical Center
UMCG, University Hospital (Groningen, The Netherlands)
Leiden University Medical Center
Erasmus Medical Center
Uniklinik RTWH Aachen
Charite University, Berlin, Germany
Ospedale San Donato
Fidenza Hospital
Desio Hospital
Gorizia Hospital
UZ Antwerpen
Medizinischen Universität Wien
University College Dublin
University of Ulster
University of Glasgow
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | time to death or a worsening heart failure event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 cardiovascular (CV) mortality |
| 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 first (re)-hospitalization due to heart failure |
| 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. | Time to all-cause hospitalization |
| Change in clinical congestion score(10) between baseline and 6 months | 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 |
| Change in QoL according to the KCCQ-CSS between baseline and 6 months | 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. |
Outcome results
None listed