Heart FailureIMMERSE-HFNCT02949544
Water Immersion in Chronic Stable Heart Failure
A study testing water immersion in people with Heart Failure, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study aims to investigate the effects of water immersion and exercise on heart function and blood flow in patients with chronic stable heart failure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- water immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2016to 4 Apr 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age >18
- Established diagnosis of heart failure with NTpro BNP >100
Who cannot join
- Uncontrolled or severe heart failure, defined by NYHA class IV symptoms (breathlessness at rest)
- Severe fluid overload characterised as more than minimal pitting oedema of the ankles only
- Presence of haemodynamically significant valvular heart disease in the opinion of the investigator
- Haemoglobin <125 g/L
- Weight >120 kilograms
- Requiring long term oxygen supplementation in the community
Show all 27Show fewer
- Hospitalisation for any cause within the last 6 weeks, that in the opinion of the investigator would affect the patients wellbeing in this study
- Unstable or severe stable angina that requires three or more antianginals
- Patients known to have disease causing immunocompromise such as HIV infection or undergoing chemotherapy
- Patients with active infection
- Dialysis patients
- Uncontrolled seizures; patients in whom the pool environment may trigger seizures, new diagnosis of epilepsy
- Insulin treated diabetic patients with hypoglycaemic episodes in the last 3 months.
- Pregnant women
- Central venous lines which are not tunnelled and are exposed superficially.
- Open access ports to lungs including tracheotomy sites
- Ventilation tubes for ears
- Nasogastric or gastrostomy tube in situ
- Presence of colostomy, ileostomy or urostomy.
- Presence of open, macerated, infected or non-intact skin or oedema with leakage of serous fluid.
- Skin condition such as severe eczema or psoriasis
- Any surgery or invasive devices fitted within the last 4 weeks
- Any form of mobility impairment requiring mobility aids (e.g. stick or wheelchair) or rendering patient unable to perform gentle exercises, including recent injury or trauma
- History of chlorine sensitivity
- Urinary or faecal incontinence
- Hydrophobia
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Water Immersion and Water-based Exercise in Patients With Chronic Stable Heart Failure: A Pilot Study
This study aims to investigate the effects of water immersion and exercise on heart function and blood flow in patients with chronic stable heart failure.
- Conditions
- Heart Failure
- Being tested
- water immersion
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water immersionOther
warm water immersion
| Study group | Role | What they receive |
|---|---|---|
| water immersion | Other | patients with heart failure will be immersed to the neck for 15 minutes Receives: Other: water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Measured: 15 minutes of water immersion
Secondary outcomes (10)
Heart rate (beats/minute)
Measured: 15 minutes of water immersion
Blood pressure (mmHg)
Measured: 15 minutes of water immersion
systemic vascular resistance (dyn·s/cm5)
Measured: 15 minutes of water immersion
Stroke volume (millilitres)
Measured: 15 minutes of water immersion
Jugular venous pressure (not raised, raised 1-4cm, raised to earlobes, undetectable)
Measured: 15 minutes of water immersion
BORG dyspnoea score (score between 1-10)
Measured: 15 minutes of water immersion
cardiac output (milliliters/minute)
Measured: 3 minutes of exercise in water
N-terminal pro b-type natriuretic peptide (ng/L)
Measured: 10 mins after water immersion
Left ventricular end systolic diameter (mm)
Measured: 15 minutes of water immersion
Left ventricular end diastolic diameters (mm)
Measured: 15 minutes of water immersion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start22 Nov 2016
- Primary completion4 Apr 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrew Clark, Principal investigator, Castle Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949544
- Sponsor's protocol ID
- R1996
- Acronym
- IMMERSE-HF
- Status last verified
- Jun 2019
- First submitted
- 13 Oct 2016
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah P, Pellicori P, Kallvikbacka-Bennett A, Zhang J, Pan D, Clark AL. Warm water immersion in patients with chronic heart failure: a pilot study : Shah immerse: HF. Clin Res Cardiol. 2019 May;108(5):468-476. doi: 10.1007/s00392-018-1376-2. Epub 2018 Sep 28.
PubMed 30267153
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Immersion and Water-based Exercise in Patients With Chronic Stable Heart Failure: A Pilot Study
- ClinicalTrials.gov ID
- NCT02949544
- Acronym / sponsor ID
- IMMERSE-HF / R1996
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 4 Apr 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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.
This study aims to investigate the effects of water immersion and exercise on heart function and blood flow in patients with chronic stable heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| water immersion | Other | Other: water immersionpatients with heart failure will be immersed to the neck for 15 minutes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18
- Established diagnosis of heart failure with NTpro BNP >100
Key exclusion criteria (27 listed)
- Uncontrolled or severe heart failure, defined by NYHA class IV symptoms (breathlessness at rest)
- Severe fluid overload characterised as more than minimal pitting oedema of the ankles only
- Presence of haemodynamically significant valvular heart disease in the opinion of the investigator
- Haemoglobin <125 g/L
- Weight >120 kilograms
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 |
|---|---|---|
| water immersionwarm water immersion | Other | water immersion |
Primary outcome
Cardiac output
Time frame: 15 minutes of water immersion
10 secondary outcomes
Heart rate (beats/minute)
Time frame: 15 minutes of water immersion
Blood pressure (mmHg)
Time frame: 15 minutes of water immersion
systemic vascular resistance (dyn·s/cm5)
Time frame: 15 minutes of water immersion
Stroke volume (millilitres)
Time frame: 15 minutes of water immersion
Jugular venous pressure (not raised, raised 1-4cm, raised to earlobes, undetectable)
Time frame: 15 minutes of water immersion
BORG dyspnoea score (score between 1-10)
Time frame: 15 minutes of water immersion
cardiac output (milliliters/minute)
Time frame: 3 minutes of exercise in water
N-terminal pro b-type natriuretic peptide (ng/L)
Time frame: 10 mins after water immersion
Left ventricular end systolic diameter (mm)
Time frame: 15 minutes of water immersion
Left ventricular end diastolic diameters (mm)
Time frame: 15 minutes of water immersion
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 19 Jun 2019.
- Results publication: PubMed 30267153Shah P, Pellicori P, Kallvikbacka-Bennett A, Zhang J, Pan D, Clark AL. Warm water immersion in patients with chronic heart failure: a pilot study : Shah immerse: HF. Clin Res Cardiol. 2019 May;108(5):468-476. doi: 10.1007/s00392-018-1376-2. Epub 2018 Sep 28.
- Full PDF Original PaperLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Andrew Clark principal investigator
Castle Hill Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water immersion in people with Heart Failure, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 27 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 19 Jun 2019. 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 United Kingdom. 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 of water immersion). 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 NCT02949544, which also lists 1 linked publication.
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 19 Jun 2019.