Heart FailureSETTLECONCT06039397
The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure
A study testing Semifowler 30' Right Lateral Body Position in people with Heart Failure and Dyspnea; Cardiac, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Heart failure is a special clinical syndrome such as difficulty breathing, fatigue, and swollen legs characterized by increased JVP, crackle lung sounds, and peripheral edema caused by heart disorders both structural and/or functional, resulting in decreased cardiac output and increased intracardiac pressure at rest… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Dyspnea; Cardiac, Acute Decompensated Heart Failure
- What is being tested?
- Semifowler 30' Right Lateral Body Position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Oct 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient was diagnosed with acute decompensated heart failure,
- fully conscious,
- not intubated,
- >18 years old,
- had no mobility problems,
- palpable radial artery pulsation,
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- was not under the influence of anti-hypotensive drugs,
- willing to be a respondent,
- LVEF <50%.
Who cannot join
- Pulmonary edema,
- severe valve disease comorbidities,
- receiving high doses of anti-hypotensive treatment,
- heart failure readmission in the last 3 months,
- finger edema,
- use of mechanical circulatory support,
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- irregular rhythms,
- artificial pacemaker attached,
- obesity
- peripheral perfusion disorders
- cardiogenic shock
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita Hospital
Jakarta, West Jakarta, 11420
About this study
Heart failure is a special clinical syndrome such as difficulty breathing, fatigue, and swollen legs characterized by increased JVP, crackle lung sounds, and peripheral edema caused by heart disorders both structural and/or functional, resulting in decreased cardiac output and increased intracardiac pressure at rest and activity. Body positioning has been shown to affect stroke volume and parasympathetic modulating activity. The right lateral 30" semifowler position is a very safe position in heart failure patients admitted to the ICU. Although body positioning can affect stroke volume, and parasympathetic modulation, it is not yet clear what effect it has on cardiac output
- Being tested
- Semifowler 30' Right Lateral Body Position, Semi-Fowler 30 Degree Position (Standard Care)
- Keywords
- Cardiac Output, Heart Failure, Body Positioning, Right Lateral Body Position, Semifowler
- Medical subject headings
- Heart Failure, Dyspnea, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semifowler 30' Right Lateral Body PositionBehavioural
Semifowler 30' Right Lateral Body Position Is a regulation of body position by placing the patient's body in a semi-fowler and lateral resting position of 30 degrees
Semi-Fowler 30 Degree Position (Standard Care)Behavioural
Standard semi-Fowler position with the head of the bed elevated to 30 degrees in the supine position, maintained for 10 minutes before cardiac output measurement. Used as the comparator condition in the crossover design.
| Study group | Role | What they receive |
|---|---|---|
| Semi-fowler 30" Right Lateral | Experimental | Not described Receives: Behavioral: Semifowler 30' Right Lateral Body Position |
| Conventional care | Active comparator | Not described Receives: Behavioral: Semi-Fowler 30 Degree Position (Standard Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
The amount of blood volume pumped by the heart for 1 minute in liters
Measured: 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start17 Oct 2023
- Primary completion30 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Responsible party
- Principal investigator, Ryan Budiyanto, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039397
- Sponsor's protocol ID
- 01.202303.046
- Acronym
- SETTLECO
- Status last verified
- Nov 2026
- First submitted
- 8 Sep 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (cardiac output and hemodynamic measurements for each period) of the 20 analysed participants will be shared.
Publications
Gottlieb LA, Blanco LSY, Hocini M, Dekker LRC, Coronel R. Self-Reported Onset of Paroxysmal Atrial Fibrillation Is Related to Sleeping Body Position. Front Physiol. 2021 Jul 15;12:708650. doi: 10.3389/fphys.2021.708650. eCollection 2021.
PubMed 34335312Carlisle MA, Fudim M, DeVore AD, Piccini JP. Heart Failure and Atrial Fibrillation, Like Fire and Fury. JACC Heart Fail. 2019 Jun;7(6):447-456. doi: 10.1016/j.jchf.2019.03.005.
PubMed 31146871Chen GY, Kuo CD. The effect of the lateral decubitus position on vagal tone. Anaesthesia. 1997 Jul;52(7):653-7. doi: 10.1111/j.1365-2044.1997.114-az0106.x.
PubMed 9244024Miyamoto S, Fujita M, Sekiguchi H, Okano Y, Nagaya N, Ueda K, Tamaki S, Nohara R, Eiho S, Sasayama S. Effects of posture on cardiac autonomic nervous activity in patients with congestive heart failure. J Am Coll Cardiol. 2001 Jun 1;37(7):1788-93. doi: 10.1016/s0735-1097(01)01249-9.
PubMed 11401112Pan H, Xu Z, Yan H, Gao Y, Chen Z, Song J, Zhang Y. Lying position classification based on ECG waveform and random forest during sleep in healthy people. Biomed Eng Online. 2018 Aug 30;17(1):116. doi: 10.1186/s12938-018-0548-7.
PubMed 30165874
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure
- ClinicalTrials.gov ID
- NCT06039397
- Acronym / sponsor ID
- SETTLECO / 01.202303.046
- Keywords
- Cardiac Output, Heart Failure, Body Positioning, Right Lateral Body Position, Semifowler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Sep 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.
Heart failure is a special clinical syndrome such as difficulty breathing, fatigue, and swollen legs characterized by increased JVP, crackle lung sounds, and peripheral edema caused by heart disorders both structural and/or functional, resulting in decreased cardiac output and increased intracardiac pressure at rest and activity. Body positioning has been shown to affect stroke volume and parasympathetic modulating activity. The right lateral 30" semifowler position is a very safe position in heart failure patients admitted to the ICU. Although body positioning can affect stroke volume, and parasympathetic modulation, it is not yet clear what effect it has on cardiac output
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semi-fowler 30" Right Lateral | Experimental | Behavioral: Semifowler 30' Right Lateral Body Position |
| Conventional care | Active comparator | Behavioral: Semi-Fowler 30 Degree Position (Standard Care) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient was diagnosed with acute decompensated heart failure,
- fully conscious,
- not intubated,
- >18 years old,
- had no mobility problems,
Key exclusion criteria (11 listed)
- Pulmonary edema,
- severe valve disease comorbidities,
- receiving high doses of anti-hypotensive treatment,
- heart failure readmission in the last 3 months,
- finger edema,
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 |
|---|---|---|
| Semifowler 30' Right Lateral Body PositionSemifowler 30' Right Lateral Body Position Is a regulation of body position by placing the patient's body in a semi-fowler and lateral resting position of 30 degrees | Behavioural | Semi-fowler 30" Right Lateral |
| Semi-Fowler 30 Degree Position (Standard Care)Standard semi-Fowler position with the head of the bed elevated to 30 degrees in the supine position, maintained for 10 minutes before cardiac output measurement. Used as the comparator condition in the crossover design. | Behavioural | Conventional care |
Primary outcome
Cardiac Output
Time frame: 15 Minutes
The amount of blood volume pumped by the heart for 1 minute in liters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 34335312Gottlieb LA, Blanco LSY, Hocini M, Dekker LRC, Coronel R. Self-Reported Onset of Paroxysmal Atrial Fibrillation Is Related to Sleeping Body Position. Front Physiol. 2021 Jul 15;12:708650. doi: 10.3389/fphys.2021.708650. eCollection 2021.
- Background: PubMed 31146871Carlisle MA, Fudim M, DeVore AD, Piccini JP. Heart Failure and Atrial Fibrillation, Like Fire and Fury. JACC Heart Fail. 2019 Jun;7(6):447-456. doi: 10.1016/j.jchf.2019.03.005.
- Background: PubMed 9244024Chen GY, Kuo CD. The effect of the lateral decubitus position on vagal tone. Anaesthesia. 1997 Jul;52(7):653-7. doi: 10.1111/j.1365-2044.1997.114-az0106.x.
- Results publication: PubMed 11401112Miyamoto S, Fujita M, Sekiguchi H, Okano Y, Nagaya N, Ueda K, Tamaki S, Nohara R, Eiho S, Sasayama S. Effects of posture on cardiac autonomic nervous activity in patients with congestive heart failure. J Am Coll Cardiol. 2001 Jun 1;37(7):1788-93. doi: 10.1016/s0735-1097(01)01249-9.
- Results publication: PubMed 30165874Pan H, Xu Z, Yan H, Gao Y, Chen Z, Song J, Zhang Y. Lying position classification based on ECG waveform and random forest during sleep in healthy people. Biomed Eng Online. 2018 Aug 30;17(1):116. doi: 10.1186/s12938-018-0548-7.
- Effect of right lateral position on hemodynamics and comfort of patients with heart failure at Harapan KitaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (cardiac output and hemodynamic measurements for each period) of the 20 analysed participants will be shared.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semifowler 30' Right Lateral Body Position in people with Heart Failure and Dyspnea; Cardiac, run by Universitas Indonesia at 1 site in Indonesia.
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 9 inclusion and 11 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: finished, as of the sponsor's last update on 4 Nov 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (time frame: 15 Minutes). 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 NCT06039397, which also lists 5 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 4 Nov 2026.