Acute Heart Failure (AHF)MUSICANCT07530029
Sarcopenia in Older Patients Hospitalized for Acute Heart Failure.
An observational study of Acute Heart Failure (AHF) and Sarcopenia, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Sarcopenia, Heart Failure
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 80 years of age of both sexes hospitalized for AHF in the Internal Medicine or the Geriatrics wards of a tertiary care hospital, with signs of fluid overload and intravenous (IV) diuretic treatment. The clinical diagnosis of HF will be made based on the presence of typical signs and symptoms, evidence of underlying structural heart disease by transthoracic echocardiography, and elevated natriuretic peptides. Only patients with LVEF ≥50% (preserved) will be included.
Who may be able to join
- 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.
Who cannot join
- End-of-life care.
- Inability to comply with study procedures.
- Already included patients on readmission.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034
Alberto Perez-Nieva, 0034913368000, apnieva@salud.madrid.org
About this study
Official title: Multimodal Approach to Sarcopenia and Its Prognostic Impact in Older Patients Hospitalized for Acute Heart Failure (MUSICA Study).
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.
Read more
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.
- Conditions
- Acute Heart Failure (AHF), Sarcopenia, Heart Failure
- Keywords
- Acute Heart Failure (AHF), Sarcopenia, Point-of-care ultrasound (PoCUS), Biomarkers, Heart Failure with Preserved Ejection Fraction
- Medical subject headings
- Sarcopenia, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of all-cause mortality and worsening heart failure
We will measure a composite outcome of all-cause mortality and worsening heart failure in a 6-month period. Worsening heart failure will be defined as rehospitalization for any cause, urgent emergency room visits for heart failure, or visits to the Heart Failure Unit with administration of iv diuretics.
Measured: From enrollment to the end of the 6-month period after hospital discharge.
Secondary outcomes (4)
All cause mortality
All-cause mortality will be determined in a 6-month period by using information from the electronic health records.
Measured: From enrollment to the end of the 6-month period after hospital discharge.
Hospitalization for any cause
Hospitalizations for any cause in a 6-month period will be recorded by review of the electronic health records.
Measured: From enrollment to the end of the 6-month period after hospital discharge.
Emergency room (ER) visits for heart failure
ER visits for heart failure will be recorded in a 6-month period by reviewing health care electronic records.
Measured: From enrollment to the end of the 6-month period after hospital discharge.
Need for intravenous diuretics in a Heart Failure Unit visit
All episodes of Heart Failure Unit visits requiring intravenous diuretic administration will be recorded by reviewing electronic health records in a 6-month period.
Measured: From enrollment to the end of the 6-month period after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start5 May 2026
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Pérez Nieva, Principal investigator, Hospital Universitario Ramon y CajalBeatriz Montero, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530029
- Sponsor's protocol ID
- IMP-25/C14
- Acronym
- MUSICA
- Status last verified
- May 2026
- First submitted
- 8 Apr 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Castiglione V, Aimo A, Vergaro G, Saccaro L, Passino C, Emdin M. Biomarkers for the diagnosis and management of heart failure. Heart Fail Rev. 2022 Mar;27(2):625-643. doi: 10.1007/s10741-021-10105-w. Epub 2021 Apr 14.
PubMed 33852110Ladang A, Beaudart C, Reginster JY, Al-Daghri N, Bruyere O, Burlet N, Cesari M, Cherubini A, da Silva MC, Cooper C, Cruz-Jentoft AJ, Landi F, Laslop A, Maggi S, Mobasheri A, Ormarsdottir S, Radermecker R, Visser M, Yerro MCP, Rizzoli R, Cavalier E. Biochemical Markers of Musculoskeletal Health and Aging to be Assessed in Clinical Trials of Drugs Aiming at the Treatment of Sarcopenia: Consensus Paper from an Expert Group Meeting Organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the Centre Academique de Recherche et d'Experimentation en Sante (CARES SPRL), Under the Auspices of the World Health Organization Collaborating Center for the Epidemiology of Musculoskeletal Conditions and Aging. Calcif Tissue Int. 2023 Feb;112(2):197-217. doi: 10.1007/s00223-022-01054-z. Epub 2023 Jan 12.
PubMed 36633611Staempfli JS, Kistler-Fischbacher M, Gewiess J, Bastian JD, Eggimann AK. The Validity of Muscle Ultrasound in the Diagnostic Workup of Sarcopenia Among Older Adults: A Scoping Review. Clin Interv Aging. 2024 May 30;19:993-1003. doi: 10.2147/CIA.S463917. eCollection 2024.
PubMed 38831963Voulgaridou G, Tyrovolas S, Detopoulou P, Tsoumana D, Drakaki M, Apostolou T, Chatziprodromidou IP, Papandreou D, Giaginis C, Papadopoulou SK. Diagnostic Criteria and Measurement Techniques of Sarcopenia: A Critical Evaluation of the Up-to-Date Evidence. Nutrients. 2024 Feb 1;16(3):436. doi: 10.3390/nu16030436.
PubMed 38337720Kirk B, Cawthon PM, Arai H, Avila-Funes JA, Barazzoni R, Bhasin S, Binder EF, Bruyere O, Cederholm T, Chen LK, Cooper C, Duque G, Fielding RA, Guralnik J, Kiel DP, Landi F, Reginster JY, Sayer AA, Visser M, von Haehling S, Woo J, Cruz-Jentoft AJ; Global Leadership Initiative in Sarcopenia (GLIS) group. The Conceptual Definition of Sarcopenia: Delphi Consensus from the Global Leadership Initiative in Sarcopenia (GLIS). Age Ageing. 2024 Mar 1;53(3):afae052. doi: 10.1093/ageing/afae052.
PubMed 38520141Sato K, Kamiya K, Hamazaki N, Nozaki K, Ichikawa T, Uchida S, Ueno K, Yamashita M, Noda T, Ogura K, Miki T, Hotta K, Maekawa E, Yamaoka-Tojo M, Matsunaga A, Ako J. Association of sarcopenia defined by different skeletal muscle mass measurements with prognosis and quality of life in older patients with heart failure. J Cardiol. 2024 Jul;84(1):59-64. doi: 10.1016/j.jjcc.2023.12.003. Epub 2023 Dec 21.
PubMed 38135146Trullas JC, Perez-Calvo JI, Conde-Martel A, Llacer Iborra P, Suarez Pedreira I, Ormaechea G, Soler Rangel L, Gonzalez Franco A, Cepeda JM, Montero-Perez-Barquero M; en representacion de los investigadores del registro RICA. Epidemiology of heart failure with preserved ejection fraction: Results from the RICA Registry. Med Clin (Barc). 2021 Jul 9;157(1):1-9. doi: 10.1016/j.medcli.2020.05.059. Epub 2020 Aug 21. English, Spanish.
PubMed 32829921
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Approach to Sarcopenia and Its Prognostic Impact in Older Patients Hospitalized for Acute Heart Failure (MUSICA Study).
- ClinicalTrials.gov ID
- NCT07530029
- Acronym / sponsor ID
- MUSICA / IMP-25/C14
- Conditions
- Acute Heart Failure (AHF), Sarcopenia, Heart Failure
- Keywords
- Acute Heart Failure (AHF), Sarcopenia, Point-of-care ultrasound (PoCUS), Biomarkers, Heart Failure with Preserved Ejection Fraction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 80 years of age of both sexes hospitalized for AHF in the Internal Medicine or the Geriatrics wards of a tertiary care hospital, with signs of fluid overload and intravenous (IV) diuretic treatment. The clinical diagnosis of HF will be made based on the presence of typical signs and symptoms, evidence of underlying structural heart disease by transthoracic echocardiography, and elevated natriuretic peptides. Only patients with LVEF ≥50% (preserved) will be included.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- End-of-life care.
- Inability to comply with study procedures.
- Already included patients on readmission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite outcome of all-cause mortality and worsening heart failure
Time frame: From enrollment to the end of the 6-month period after hospital discharge.
We will measure a composite outcome of all-cause mortality and worsening heart failure in a 6-month period. Worsening heart failure will be defined as rehospitalization for any cause, urgent emergency room visits for heart failure, or visits to the Heart Failure Unit with administration of iv diuretics.
4 secondary outcomes
All cause mortality
Time frame: From enrollment to the end of the 6-month period after hospital discharge.
Hospitalization for any cause
Time frame: From enrollment to the end of the 6-month period after hospital discharge.
Emergency room (ER) visits for heart failure
Time frame: From enrollment to the end of the 6-month period after hospital discharge.
Need for intravenous diuretics in a Heart Failure Unit visit
Time frame: From enrollment to the end of the 6-month period after hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 33852110Castiglione V, Aimo A, Vergaro G, Saccaro L, Passino C, Emdin M. Biomarkers for the diagnosis and management of heart failure. Heart Fail Rev. 2022 Mar;27(2):625-643. doi: 10.1007/s10741-021-10105-w. Epub 2021 Apr 14.
- Background: PubMed 36633611Ladang A, Beaudart C, Reginster JY, Al-Daghri N, Bruyere O, Burlet N, Cesari M, Cherubini A, da Silva MC, Cooper C, Cruz-Jentoft AJ, Landi F, Laslop A, Maggi S, Mobasheri A, Ormarsdottir S, Radermecker R, Visser M, Yerro MCP, Rizzoli R, Cavalier E. Biochemical Markers of Musculoskeletal Health and Aging to be Assessed in Clinical Trials of Drugs Aiming at the Treatment of Sarcopenia: Consensus Paper from an Expert Group Meeting Organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the Centre Academique de Recherche et d'Experimentation en Sante (CARES SPRL), Under the Auspices of the World Health Organization Collaborating Center for the Epidemiology of Musculoskeletal Conditions and Aging. Calcif Tissue Int. 2023 Feb;112(2):197-217. doi: 10.1007/s00223-022-01054-z. Epub 2023 Jan 12.
- Background: PubMed 38831963Staempfli JS, Kistler-Fischbacher M, Gewiess J, Bastian JD, Eggimann AK. The Validity of Muscle Ultrasound in the Diagnostic Workup of Sarcopenia Among Older Adults: A Scoping Review. Clin Interv Aging. 2024 May 30;19:993-1003. doi: 10.2147/CIA.S463917. eCollection 2024.
- Background: PubMed 38337720Voulgaridou G, Tyrovolas S, Detopoulou P, Tsoumana D, Drakaki M, Apostolou T, Chatziprodromidou IP, Papandreou D, Giaginis C, Papadopoulou SK. Diagnostic Criteria and Measurement Techniques of Sarcopenia: A Critical Evaluation of the Up-to-Date Evidence. Nutrients. 2024 Feb 1;16(3):436. doi: 10.3390/nu16030436.
- Background: PubMed 38520141Kirk B, Cawthon PM, Arai H, Avila-Funes JA, Barazzoni R, Bhasin S, Binder EF, Bruyere O, Cederholm T, Chen LK, Cooper C, Duque G, Fielding RA, Guralnik J, Kiel DP, Landi F, Reginster JY, Sayer AA, Visser M, von Haehling S, Woo J, Cruz-Jentoft AJ; Global Leadership Initiative in Sarcopenia (GLIS) group. The Conceptual Definition of Sarcopenia: Delphi Consensus from the Global Leadership Initiative in Sarcopenia (GLIS). Age Ageing. 2024 Mar 1;53(3):afae052. doi: 10.1093/ageing/afae052.
- Background: PubMed 38135146Sato K, Kamiya K, Hamazaki N, Nozaki K, Ichikawa T, Uchida S, Ueno K, Yamashita M, Noda T, Ogura K, Miki T, Hotta K, Maekawa E, Yamaoka-Tojo M, Matsunaga A, Ako J. Association of sarcopenia defined by different skeletal muscle mass measurements with prognosis and quality of life in older patients with heart failure. J Cardiol. 2024 Jul;84(1):59-64. doi: 10.1016/j.jjcc.2023.12.003. Epub 2023 Dec 21.
- Background: PubMed 32829921Trullas JC, Perez-Calvo JI, Conde-Martel A, Llacer Iborra P, Suarez Pedreira I, Ormaechea G, Soler Rangel L, Gonzalez Franco A, Cepeda JM, Montero-Perez-Barquero M; en representacion de los investigadores del registro RICA. Epidemiology of heart failure with preserved ejection fraction: Results from the RICA Registry. Med Clin (Barc). 2021 Jul 9;157(1):1-9. doi: 10.1016/j.medcli.2020.05.059. Epub 2020 Aug 21. English, Spanish.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alberto Pérez Nieva principal investigator
Hospital Universitario Ramon y Cajal
Beatriz Montero principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure (AHF) and Sarcopenia, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Pérez-Nieva, MD (+34 913 36 80 00, apnieva@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of all-cause mortality and worsening heart failure (time frame: From enrollment to the end of the 6-month period after hospital discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07530029, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.