NCT07530029 Sarcopenia in Older Patients Hospitalized for Acute Heart Failure.
| NCT ID | NCT07530029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
| Condition | Acute Heart Failure (AHF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-05-05 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2026-05-05 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Acute heart failure (AHF) is the leading cause of hospitalization in people over 65, with the group with preserved ejection fraction (HFpEF) being the most closely related to aging. Among its comorbidities, sarcopenia stands out, and its assessment requires measurement of muscle mass. Muscle ultrasound is an accessible and economical alternative, although its prognostic value is still uncertain. The presence of common pathophysiological mechanisms between HF-PEF and sarcopenia leads to the study of biomarkers to improve their characterization. Multimodal characterization of sarcopenia, integrating muscle mass and strength with skeletal and cardiac muscle biomarkers, will improve prognostic stratification at discharge in elderly patients with HFpEF hospitalized for ACS. We seek to evaluate the prognostic value of muscle mass estimated by ultrasound, in combination with strength measurements and circulating biomarkers related to sarcopenia, as this could improve the prediction of clinical events after hospitalization for AHF in elderly patients with HFpEF. In addition, ultrasound estimation of muscle mass will be analyzed against BIA, the relationship between skeletal and cardiac muscle will be characterized, and the usefulness of the multimodal approach to sarcopenia will be evaluated. This study is observational, prospective, and single-center. It will include 110 patients hospitalized for AHF aged ≥80 years. Events will be monitored for 6 months after discharge. Variables include clinical data, ultrasound data (lung, VExUS, and muscle mass), congestion markers (BNP, CA125), biomarkers (GDF-15, sST2, BDNF, and myostatin/follistatin), bioimpedance, and dynamometry. Data will be analyzed using regression models and survival analysis to identify prognostic factors. This study has the potential to improve the clinical management of patients with acute heart failure by providing key information on its interaction with sarcopenia. The results could help identify more effective strategies to reduce rehospitalization and mortality in these patients, improving their prognosis and quality of life.
Eligibility Criteria
Inclusion Criteria: * Patients with HF-pEF (LVEF ≥50%), hospitalized for AHF, with signs of fluid overload and requiring intravenous diuretic treatment. The diagnosis of HF will be made in accordance with ESC-2021 guidelines based on the presence of typical signs and symptoms, elevated natriuretic peptides (BNP \>100 pg/mL or NTproBNP \>300 pg/mL), and evidence of underlying structural heart disease by transthoracic echocardiography (performed during admission or within a period of 24 months prior to admission). * Age ≥ 80 years. * NYHA functional class II-IV. Exclusion Criteria: * End-of-life care. * Inability to comply with study procedures. * Already included patients on readmission.
Contact & Investigator
Alberto Pérez Nieva
PRINCIPAL INVESTIGATOR
Hospital Universitario Ramón y Cajal
Frequently Asked Questions
Who can join the NCT07530029 clinical trial?
This trial is open to participants of all sexes, aged 80 Years or older, studying Acute Heart Failure (AHF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07530029 currently recruiting?
Yes, NCT07530029 is actively recruiting participants. Contact the research team at apnieva@salud.madrid.org for enrollment information.
Where is the NCT07530029 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07530029 clinical trial?
NCT07530029 is sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. The principal investigator is Alberto Pérez Nieva at Hospital Universitario Ramón y Cajal. The trial plans to enroll 110 participants.
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