Water Immersion in Chronic Stable Heart Failure (IMMERSE-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
water immersion
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Age >18
- Established diagnosis of heart failure with NTpro BNP >100
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Castle Hill Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
water immersion
Arm Description
patients with heart failure will be immersed to the neck for 15 minutes
Outcomes
Primary Outcome Measures
Cardiac output
Secondary Outcome Measures
Heart rate (beats/minute)
Blood pressure (mmHg)
systemic vascular resistance (dyn·s/cm5)
Stroke volume (millilitres)
Jugular venous pressure (not raised, raised 1-4cm, raised to earlobes, undetectable)
BORG dyspnoea score (score between 1-10)
cardiac output (milliliters/minute)
N-terminal pro b-type natriuretic peptide (ng/L)
Left ventricular end systolic diameter (mm)
Left ventricular end diastolic diameters (mm)
Full Information
NCT ID
NCT02949544
First Posted
October 13, 2016
Last Updated
June 17, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02949544
Brief Title
Water Immersion in Chronic Stable Heart Failure
Acronym
IMMERSE-HF
Official Title
Water Immersion and Water-based Exercise in Patients With Chronic Stable Heart Failure: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 22, 2016 (Actual)
Primary Completion Date
April 4, 2017 (Actual)
Study Completion Date
April 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
water immersion
Arm Type
Other
Arm Description
patients with heart failure will be immersed to the neck for 15 minutes
Intervention Type
Other
Intervention Name(s)
water immersion
Intervention Description
warm water immersion
Primary Outcome Measure Information:
Title
Cardiac output
Time Frame
15 minutes of water immersion
Secondary Outcome Measure Information:
Title
Heart rate (beats/minute)
Time Frame
15 minutes of water immersion
Title
Blood pressure (mmHg)
Time Frame
15 minutes of water immersion
Title
systemic vascular resistance (dyn·s/cm5)
Time Frame
15 minutes of water immersion
Title
Stroke volume (millilitres)
Time Frame
15 minutes of water immersion
Title
Jugular venous pressure (not raised, raised 1-4cm, raised to earlobes, undetectable)
Time Frame
15 minutes of water immersion
Title
BORG dyspnoea score (score between 1-10)
Time Frame
15 minutes of water immersion
Title
cardiac output (milliliters/minute)
Time Frame
3 minutes of exercise in water
Title
N-terminal pro b-type natriuretic peptide (ng/L)
Time Frame
10 mins after water immersion
Title
Left ventricular end systolic diameter (mm)
Time Frame
15 minutes of water immersion
Title
Left ventricular end diastolic diameters (mm)
Time Frame
15 minutes of water immersion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age >18
Established diagnosis of heart failure with NTpro BNP >100
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Clark
Organizational Affiliation
Castle Hill Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU165JQ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30267153
Citation
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.
Results Reference
result
Links:
URL
https://link.springer.com/content/pdf/10.1007%2Fs00392-018-1376-2.pdf
Description
Full PDF Original Paper
Learn more about this trial
Water Immersion in Chronic Stable Heart Failure
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