Cardiovascular DiseasesINDEPENDENCYNCT05946174
Tackling Disruptions to Frailty Interventions: Developing Personalized Interventions Targeted for Older Persons With Cardiac Frailty
A study testing Intervention Set A, Intervention Set B and Intervention Set C in people with Cardiovascular Diseases, run by National Heart Centre Singapore at 6 sites in Singapore.
Trial summary
Background: Muscle mass loss and metabolic dysfunction, exacerbated by inactivity and nutritional inadequacies, underpin both cardiovascular disease and frailty in ageing. The investigators' proposal seeks to develop interventions in exercise and diet that are targeted for older adults with cardiac frailty. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Intervention Set A, Intervention Set B and Intervention Set C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 6 sitesSingapore
- Study dates
- 12 Jul 2023to 21 Jun 2028
- Phase
- Interventional
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years old
- Outdoor ambulant
Who cannot join
- Bed-bound
- Dementia (Stage 6 onwards)
- Residing in sheltered or nursing home
- Cancer (to avoid confounding with cardiac disease sequelae from cancer)
- Participation in ongoing clinical trials that involve interventional drugs or devices
- Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥90mmHg) despite being on treatment for hypertension
Show all 23Show fewer
- Low blood pressure (systolic blood pressure <90mmHg or diastolic blood pressure <40mmHg)
- Uncontrolled atrial fibrillation (controlled atrial fibrillation is allowed)
- Ventricular arrhythmias (such as ventricular tachycardia)
- Renal failure on dialysis
- Chronic kidney disease Stage 4 and above
- Nephrotic syndrome
- Liver cirrhosis Child's B and above
- Inflammatory Bowel Disease
- Severe uncontrolled gout
- Poorly controlled Diabetes Hba1c ≥9%
- On warfarin
- Presence of food allergies (such as shell-fish, prawn)
- Patient's life expectancy is expected to be less than one year at the time of potential enrolment as assessed by the investigator
- Nasogastric or parenteral nutrition
- Hypertrophic cardiomyopathy
- Cardiac amyloidosis
- Cardiac sarcoidosis
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Singapore6 sites, 6 recruiting
- Recruiting
Alexandra Hospital
Singapore, 159964
Laureen Yi-Ting Wang
- Recruiting
National Heart Centre Singapore
Singapore, 169609
Angela Su-Mei Koh, MBBS, MPH, +65 6704 8961, angela.koh.s.m@singhealth.com.sg
Gina Sihui Lee, +65 6704 2228, gina.lee.s.h@nhcs.com.sg
- Recruiting
Changi General Hospital
Singapore, 529889
Chun How Ooi
- Recruiting
Sengkang General Hospital
Singapore, 544886
Zijuan Huang
- Recruiting
Jurong Community Hospital
Singapore, 609606
Alvin Ong
- Recruiting
NHG Polyclinics
Singapore
Shu Yun Tan
About this study
Background: Muscle mass loss and metabolic dysfunction, exacerbated by inactivity and nutritional inadequacies, underpin both cardiovascular disease and frailty in ageing. The investigators' proposal seeks to develop interventions in exercise and diet that are targeted for older adults with cardiac frailty.
Methods:
Read more
The investigators' proposal is a five-year study comprising of first phase (first 2-2.5 years) and second phase (next 2-2.5 years). In the first phase cardiac frail participants (up to N=500) from each healthcare transition (inpatient hospital, step-down community hospital, outpatient clinic/community) will be randomized to receive Intervention Sets or usual care. The second phase will scale up these programs. Three Intervention Sets A, B, and C will be implemented in the outpatient, step-down community hospital, and acute hospital settings. Diet intervention comprises meal sets prepared with nutrients involved in energy metabolism. Exercise training is facilitated by hospital gyms and hospital physiotherapists. Diet and exercise behavior will be monitored using questionnaires, video conferencing and meal photos.
Significance: Clinical studies are urgently needed using consistent frailty tools to evaluate the efficacy and promise of frailty interventions, targeted to achieve reversal/retardation of frailty. When scaled up, these approaches will provide high-quality science needed to manage cardiac frailty towards healthier population ageing.
Read the detailed description
BACKGROUND Cardiovascular disease is a formidable disruptor of interventions related to exercise intervention. Patients and physicians face uncertainty about dispensing safe and effective exercise programs to frail patients with concomitant cardiovascular disease. This hesitancy permeates across transitions from acute to step-down care to community settings. Uncertainties include fear of exacerbating heart conditions, individual variability in exercise response and what exercise targets to reach that is rational for each patient. Often, little or no exercise intervention is applied in the acute to step-down phases, which are the periods most critical for frailty reversal. Current dietary interventions do not address the special nutritional needs of acute cardiovascular conditions like heart failure, and may paradoxically induce a syndrome of cardiac cachexia that contributes to the downward spiral of frailty.
STUDY DESIGN:
This will be a prospective randomized clinical trial.
The investigators' proposal is a five-year study comprising of first phase (first 2-2.5 years) and second phase (next 2-2.5 years). In the first phase cardiac frail participants (up to N=500) from each healthcare transition (inpatient hospital, step-down community hospital, outpatient clinic/community) will be randomized to receive Intervention Sets or usual care. The second phase will scale up these programs. At enrolment, pre-defined study time points and end of study, participants will undergo assessments of clinical status, frailty status, cardiovascular function, nutrition, quality of life (QOL), diet/exercise behaviour, and biospecimen sampling. Three Intervention Sets will be implemented in the outpatient, step-down community hospital, and acute hospital settings. Diet intervention comprises meal sets prepared with nutrients involved in energy metabolism. During the trial, exercise intervention is performed in hospitals and community hospitals by physiotherapists. Associated factors such as dietary, comorbidities and other related habits will be tracked simultaneously during the trial
Intervention Set A: exercise sessions and meals over approximately 12 weeks. Intervention Set B : exercise sessions and meals over approximately 3 weeks. Intervention Set C: meals over approximately 3 weeks.
PROCEDURES
- Baseline Procedures i. Cardiovascular measurements
- Non-invasive brachial blood pressure machine
- Echocardiography
- Electrocardiography ii. Biospecimen collection iii. Six-minute walk test iv. Musculoskeletal Analysis v. Cardiopulmonary exercise test (CPET)/ Treadmill vi. Questionnaires vii. Timed up and go (TUG) test
- Post-intervention procedures i. Cardiovascular measurements
- Non-invasive brachial blood pressure machine
- Echocardiography
- Electrocardiography ii. Biospecimen collection iii. Six-minute walk test iv. Musculoskeletal Analysis v. Questionnaires vi. Timed up and go (TUG) test
- Closing questionnaires
- Conditions
- Cardiovascular Diseases
- Being tested
- Intervention Set A, Intervention Set B, Intervention Set C
- Keywords
- Frailty, Intervention, Cardiac Frailty Interventions
- Medical subject headings
- Cardiovascular Diseases, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Set AOther
exercise sessions and meals over approximately 12 weeks
Intervention Set BOther
exercise sessions and meals over approximately 3 weeks
Intervention Set COther
meals over approximately 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Outpatient clinic/community participants receiving exercise sessions and meals (A1) | Experimental | Outpatient clinic/community participants receiving intervention Set A (exercise sessions and meals over approximately 12 weeks) Receives: Other: Intervention Set A |
| Outpatient clinic/community participants receiving control/usual care (A2) | No intervention | Outpatient clinic/community participants receiving control/usual care |
| Step-down community hospital participants receiving exercise sessions and meals (B1) | Experimental | Step-down community hospital participants receiving Intervention Set B (exercise sessions and meals over approximately 3 weeks) Receives: Other: Intervention Set B |
| Step-down community hospital participants receiving control/usual care (B2) | No intervention | Step-down community hospital participants receiving control/usual care |
| Acute hospital participants receiving meals (C1) | Experimental | Acute hospital participants receiving Intervention Set C (meals over approximately 3 weeks) Receives: Other: Intervention Set C |
| Acute hospital participants receiving control/usual care (C2) | No intervention | Acute hospital participants receiving control/usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in cardiovascular markers
- Change in cardiovascular variables are diastolic function variables such as mitral annular velocities (m/s) OR;
- Change in Aerobic capacity (V02, ml/kg/min)
Measured: at 14 weeks from baseline
Improvement in skeletal muscle
Change in skeletal muscle mass (grams)
Measured: at 14 weeks from baseline
Improvement in Fried Frailty Phenotype Score (improvement in any domain) (i.e., reduction in score)
Measured: at six months from baseline
Secondary outcomes (2)
Improvement in metabolite level
Any change in metabolite (microM)
Measured: Three months and six months from baseline
Improvement in Quality of life (QOL): EuroQOL-5D-5L (higher score)
A unit increase (i.e., improvement) in QOL score
Measured: Three months and six months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start12 Jul 2023
- Primary completion21 Jun 2028 (estimated)
- Study completion21 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Set A comprises of outpatient clinic/ community participants, who will be randomized in a 1:1 ratio into Group A1 (receiving Intervention Set A- exercise sessions and meals over approximately 12 weeks) or Group A2 (control/ usual care) Set B comprises of step-down community hospital participants, who will be randomized in a 1:1 ratio into Group B1 (receiving Intervention Set B- exercise sessions and meals over approximately 3 weeks) or Group B2 (control/ usual care) Set C comprises of acute community hospital participants, who will be randomized in a 1:1 ratio into Group C1 (receiving Intervention Set C- meals over approximately 3 weeks) or Group C2 (control/ usual care)
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Su-Mei Koh, MBBS, MPH, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946174
- Sponsor's protocol ID
- 2023/2086
- Acronym
- INDEPENDENCY
- Status last verified
- Apr 2025
- First submitted
- 15 Jun 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koh AS, Gao F, Leng S, Kovalik JP, Zhao X, Tan RS, Fridianto KT, Ching J, Chua SJ, Yuan JM, Koh WP, Zhong L. Dissecting Clinical and Metabolomics Associations of Left Atrial Phasic Function by Cardiac Magnetic Resonance Feature Tracking. Sci Rep. 2018 May 25;8(1):8138. doi: 10.1038/s41598-018-26456-8.
PubMed 29802321Koh AS, Gao F, Liu J, Fridianto KT, Ching J, Tan RS, Wong JI, Chua SJ, Leng S, Zhong L, Keng BM, Huang FQ, Yuan JM, Koh WP, Kovalik JP. Metabolomic profile of arterial stiffness in aged adults. Diab Vasc Dis Res. 2018 Jan;15(1):74-80. doi: 10.1177/1479164117733627. Epub 2017 Oct 4.
PubMed 28976207Keng BMH, Gao F, Teo LLY, Lim WS, Tan RS, Ruan W, Ewe SH, Koh WP, Koh AS. Associations between Skeletal Muscle and Myocardium in Aging: A Syndrome of "Cardio-Sarcopenia"? J Am Geriatr Soc. 2019 Dec;67(12):2568-2573. doi: 10.1111/jgs.16132. Epub 2019 Aug 16.
PubMed 31418823Koh AS, Gao F, Tan RS, Zhong L, Leng S, Zhao X, Fridianto KT, Ching J, Lee SY, Keng BMH, Yeo TJ, Tan SY, Tan HC, Lim CT, Koh WP, Kovalik JP. Metabolomic correlates of aerobic capacity among elderly adults. Clin Cardiol. 2018 Oct;41(10):1300-1307. doi: 10.1002/clc.23016.
PubMed 30350416
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tackling Disruptions to Frailty Interventions: Developing Personalized Interventions Targeted for Older Persons With Cardiac Frailty
- ClinicalTrials.gov ID
- NCT05946174
- Acronym / sponsor ID
- INDEPENDENCY / 2023/2086
- Conditions
- Cardiovascular Diseases
- Keywords
- Frailty, Intervention, Cardiac Frailty Interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 21 Jun 2028 (estimated)
- Study completion
- 21 Jun 2028 (estimated)
- First posted
- 14 Jul 2023 (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.
Background: Muscle mass loss and metabolic dysfunction, exacerbated by inactivity and nutritional inadequacies, underpin both cardiovascular disease and frailty in ageing. The investigators' proposal seeks to develop interventions in exercise and diet that are targeted for older adults with cardiac frailty.
Methods:
The investigators' proposal is a five-year study comprising of first phase (first 2-2.5 years) and second phase (next 2-2.5 years). In the first phase cardiac frail participants (up to N=500) from each healthcare transition (inpatient hospital, step-down community hospital, outpatient clinic/community) will be randomized to receive Intervention Sets or usual care. The second phase will scale up these programs. Three Intervention Sets A, B, and C will be implemented in the outpatient, step-down community hospital, and acute hospital settings. Diet intervention comprises meal sets prepared with nutrients involved in energy metabolism. Exercise training is facilitated by hospital gyms and hospital physiotherapists. Diet and exercise behavior will be monitored using questionnaires, video conferencing and meal photos.
Significance: Clinical studies are urgently needed using consistent frailty tools to evaluate the efficacy and promise of frailty interventions, targeted to achieve reversal/retardation of frailty. When scaled up, these approaches will provide high-quality science needed to manage cardiac frailty towards healthier population ageing.
Detailed description
BACKGROUND Cardiovascular disease is a formidable disruptor of interventions related to exercise intervention. Patients and physicians face uncertainty about dispensing safe and effective exercise programs to frail patients with concomitant cardiovascular disease. This hesitancy permeates across transitions from acute to step-down care to community settings. Uncertainties include fear of exacerbating heart conditions, individual variability in exercise response and what exercise targets to reach that is rational for each patient. Often, little or no exercise intervention is applied in the acute to step-down phases, which are the periods most critical for frailty reversal. Current dietary interventions do not address the special nutritional needs of acute cardiovascular conditions like heart failure, and may paradoxically induce a syndrome of cardiac cachexia that contributes to the downward spiral of frailty.
STUDY DESIGN:
This will be a prospective randomized clinical trial.
The investigators' proposal is a five-year study comprising of first phase (first 2-2.5 years) and second phase (next 2-2.5 years). In the first phase cardiac frail participants (up to N=500) from each healthcare transition (inpatient hospital, step-down community hospital, outpatient clinic/community) will be randomized to receive Intervention Sets or usual care. The second phase will scale up these programs. At enrolment, pre-defined study time points and end of study, participants will undergo assessments of clinical status, frailty status, cardiovascular function, nutrition, quality of life (QOL), diet/exercise behaviour, and biospecimen sampling. Three Intervention Sets will be implemented in the outpatient, step-down community hospital, and acute hospital settings. Diet intervention comprises meal sets prepared with nutrients involved in energy metabolism. During the trial, exercise intervention is performed in hospitals and community hospitals by physiotherapists. Associated factors such as dietary, comorbidities and other related habits will be tracked simultaneously during the trial
Intervention Set A: exercise sessions and meals over approximately 12 weeks. Intervention Set B : exercise sessions and meals over approximately 3 weeks. Intervention Set C: meals over approximately 3 weeks.
PROCEDURES
- Baseline Procedures i. Cardiovascular measurements
- Non-invasive brachial blood pressure machine
- Echocardiography
- Electrocardiography ii. Biospecimen collection iii. Six-minute walk test iv. Musculoskeletal Analysis v. Cardiopulmonary exercise test (CPET)/ Treadmill vi. Questionnaires vii. Timed up and go (TUG) test
- Post-intervention procedures i. Cardiovascular measurements
- Non-invasive brachial blood pressure machine
- Echocardiography
- Electrocardiography ii. Biospecimen collection iii. Six-minute walk test iv. Musculoskeletal Analysis v. Questionnaires vi. Timed up and go (TUG) test
- Closing questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Set A comprises of outpatient clinic/ community participants, who will be randomized in a 1:1 ratio into Group A1 (receiving Intervention Set A- exercise sessions and meals over approximately 12 weeks) or Group A2 (control/ usual care) Set B comprises of step-down community hospital participants, who will be randomized in a 1:1 ratio into Group B1 (receiving Intervention Set B- exercise sessions and meals over approximately 3 weeks) or Group B2 (control/ usual care) Set C comprises of acute community hospital participants, who will be randomized in a 1:1 ratio into Group C1 (receiving Intervention Set C- meals over approximately 3 weeks) or Group C2 (control/ usual care)
| Arm | Type | Receives |
|---|---|---|
| Outpatient clinic/community participants receiving exercise sessions and meals (A1) | Experimental | Other: Intervention Set AOutpatient clinic/community participants receiving intervention Set A (exercise sessions and meals over approximately 12 weeks) |
| Outpatient clinic/community participants receiving control/usual care (A2) | No intervention | –Outpatient clinic/community participants receiving control/usual care |
| Step-down community hospital participants receiving exercise sessions and meals (B1) | Experimental | Other: Intervention Set BStep-down community hospital participants receiving Intervention Set B (exercise sessions and meals over approximately 3 weeks) |
| Step-down community hospital participants receiving control/usual care (B2) | No intervention | –Step-down community hospital participants receiving control/usual care |
| Acute hospital participants receiving meals (C1) | Experimental | Other: Intervention Set CAcute hospital participants receiving Intervention Set C (meals over approximately 3 weeks) |
| Acute hospital participants receiving control/usual care (C2) | No intervention | –Acute hospital participants receiving control/usual care |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 21 years old
- Outdoor ambulant
Key exclusion criteria (23 listed)
- Bed-bound
- Dementia (Stage 6 onwards)
- Residing in sheltered or nursing home
- Cancer (to avoid confounding with cardiac disease sequelae from cancer)
- Participation in ongoing clinical trials that involve interventional drugs or devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Set Aexercise sessions and meals over approximately 12 weeks | Other | Outpatient clinic/community participants receiving exercise sessions and meals (A1) |
| Intervention Set Bexercise sessions and meals over approximately 3 weeks | Other | Step-down community hospital participants receiving exercise sessions and meals (B1) |
| Intervention Set Cmeals over approximately 3 weeks | Other | Acute hospital participants receiving meals (C1) |
Primary outcome
Improvement in cardiovascular markers
Time frame: at 14 weeks from baseline
* Change in cardiovascular variables are diastolic function variables such as mitral annular velocities (m/s) OR; * Change in Aerobic capacity (V02, ml/kg/min)
Improvement in skeletal muscle
Time frame: at 14 weeks from baseline
Change in skeletal muscle mass (grams)
Improvement in Fried Frailty Phenotype Score (improvement in any domain) (i.e., reduction in score)
Time frame: at six months from baseline
2 secondary outcomes
Improvement in metabolite level
Time frame: Three months and six months from baseline
Improvement in Quality of life (QOL): EuroQOL-5D-5L (higher score)
Time frame: Three months and six months from baseline
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 5 Jun 2025.
- Background: PubMed 29802321Koh AS, Gao F, Leng S, Kovalik JP, Zhao X, Tan RS, Fridianto KT, Ching J, Chua SJ, Yuan JM, Koh WP, Zhong L. Dissecting Clinical and Metabolomics Associations of Left Atrial Phasic Function by Cardiac Magnetic Resonance Feature Tracking. Sci Rep. 2018 May 25;8(1):8138. doi: 10.1038/s41598-018-26456-8.
- Background: PubMed 28976207Koh AS, Gao F, Liu J, Fridianto KT, Ching J, Tan RS, Wong JI, Chua SJ, Leng S, Zhong L, Keng BM, Huang FQ, Yuan JM, Koh WP, Kovalik JP. Metabolomic profile of arterial stiffness in aged adults. Diab Vasc Dis Res. 2018 Jan;15(1):74-80. doi: 10.1177/1479164117733627. Epub 2017 Oct 4.
- Background: PubMed 31418823Keng BMH, Gao F, Teo LLY, Lim WS, Tan RS, Ruan W, Ewe SH, Koh WP, Koh AS. Associations between Skeletal Muscle and Myocardium in Aging: A Syndrome of "Cardio-Sarcopenia"? J Am Geriatr Soc. 2019 Dec;67(12):2568-2573. doi: 10.1111/jgs.16132. Epub 2019 Aug 16.
- Background: PubMed 30350416Koh AS, Gao F, Tan RS, Zhong L, Leng S, Zhao X, Fridianto KT, Ching J, Lee SY, Keng BMH, Yeo TJ, Tan SY, Tan HC, Lim CT, Koh WP, Kovalik JP. Metabolomic correlates of aerobic capacity among elderly adults. Clin Cardiol. 2018 Oct;41(10):1300-1307. doi: 10.1002/clc.23016.
- Individual participant dataSharing planned: No
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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.
Angela Su-Mei Koh, MBBS, MPH principal investigator
National Heart Centre Singapore
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Set A, Intervention Set B and Intervention Set C in people with Cardiovascular Diseases, run by National Heart Centre Singapore at 6 sites in Singapore.
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 2 inclusion and 23 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Singapore. 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 Angela Su-Mei Koh (+65 6704 8961, angela.koh.s.m@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in cardiovascular markers (time frame: at 14 weeks from baseline). The study lists 3 primary outcomes in all. 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 NCT05946174, which also lists 4 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 5 Jun 2025.